Almac Diagnostic Services, part of the Almac Group, today announces further investment in its global Next Generation Sequencing (NGS) infrastructure to support biomarker driven clinical research.

This infrastructure expansion includes the addition of Thermo Fisher Scientific’s Ion Torrent Genexus™ System, which supports the delivery of high‑quality genomic data for biomarker discovery and patient stratification in both early- and late-phase clinical trials. It also strengthens Almac’s targeted DNA and RNA sequencing offerings, reinforcing its position as a trusted partner for precision medicine.

Sponsors will now benefit from an integrated, end‑to‑end NGS workflow made possible by the Ion Torrent Genexus™ System, which combines library preparation, sequencing, data analysis and reporting within a single platform. Automation of key steps reduces manual handling and variability, helping to deliver consistent, high‑quality genomic data with faster turnaround times.

By expanding NGS capabilities within its laboratory, Almac Diagnostic Services further strengthens its ability to support global clinical trials from its existing multi-omic laboratories in UK / Europe and the United States. This latest investment reflects its ongoing commitment to expand its clinical trial solutions, supporting biopharmaceutical partners evolving needs for global technologies that enable biomarker‑driven, drug development programmes.

Michael Sloan, Global Vice President of Commercial Operations, Almac Diagnostic Services, commented:

“This investment further enhances our NGS capabilities for biopharma partners. The platform supports faster, more streamlined genomic testing while maintaining the quality, consistency and regulatory rigour required for clinical trial applications.

It forms part of our ongoing strategy to invest in technologies that help customers accelerate development and bring targeted therapies to patients sooner.”

For more information on Almac Diagnostic Services range of services visit: www.almacgroup.com/diagnostics

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Almac Diagnostic Services, a member of the Almac Group, has today announced the launch of a new PNPLA3 genotyping kit for liver disease research. This novel kit provides accurate genotyping of the PNPLA3 gene within a simple workflow, providing researchers with further biological insights into steatotic liver disease (including MASH and MASLD).

The Almac qPCR based kit delivers highly repeatable and reproducible results (≥99%) from blood or buccal swab specimens, with hands-on time of less than 30 minutes. It includes three genotyping assay controls to ensure confidence for researchers in allelic assay calls. 

Metabolic dysfunction-associated steatotic liver disease (MASLD), is one of the most common forms of chronic liver disease, with an estimated prevalence of about 30% across many countries.¹  The I148M genotype variant of the PNPLA3 gene is linked to liver disease severity and fibrosis progression even in the absence of classical metabolic dysfunction such as obesity.

By providing a reliable method to genotype the PNPLA3 gene, Almac is enabling researchers to identify genetic risk factors to understand the underlying genetic predisposition to MASLD better, to investigate how the I148M variant influences disease severity and fibrosis progression, and to develop future targeted therapies through better disease population understanding.

Michael Sloan, Global VP of Commercial Development, Almac Diagnostic Services said: “The launch of the Almac PNPLA3 Genotyping Kit represents our commitment to providing researchers with the tools they need to uncover useful biological information to further precision medicine in liver disease.”

Almac Diagnostic Services will be attending EASL 2025 in Amsterdam from 7-10 May to launch and promote the new kit. EASL is one of Europe’s largest liver disease conferences. Almac will be exhibiting at Booth #BS7 in Hall 12. See: https://www.almacgroup.com/events/easl-congress-2025/

To find out more about Almac’s PNPLA3 Genotyping Kit and to order go to: https://www.almacgroup.com/diagnostics/almac-pnpla3-genotyping-kit/

References:

¹ – The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review https://pubmed.ncbi.nlm.nih.gov/36626630/

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The Almac Single Cell Next Generation Sequencing (NGS) solution for biomarker discovery leverages the 10x Genomics Chromium X platform and chemistries to produce RNA-Seq data at the cellular level. This service is compatible with cell suspensions stored in Cryo-preservative or treated with Formaldehyde.

Almac’s Single Cell Sequencing service features a scalable bioinformatic pipeline powered by 10x Genomics’ Cell Ranger software, ensuring comprehensive quality control and precise single cell gene expression analysis. Clients can also opt for Almac’s custom bioinformatics solutions, which include cell type identification, differential expression analysis between cell types and pathway analysis.

Almac Diagnostic Services lab is the first commercial laboratory in Northern Ireland to achieve 10x Genomics Certified Service Provider (CSP) status. The certification was awarded in recognition of Almac’s expertise and data quality for single cell RNA-Seq projects. The CSP status ensures that clients benefit from best practice, are supported to overcome research challenges and can accelerate projects with confidence in the results.

Dr Laura Knight, Global VP of Genomic Services, Almac Diagnostic Services said: “By integrating Almac’s single cell workflows and bioinformatics options with 10x Genomics’ Chromium technology, we empower our clients with high quality single cell sequencing solutions to advance their translational medicine goals.

“Almac Diagnostic Services is dedicated to expanding our Genomic Services portfolio, in response to client needs, incorporating innovative technologies like single cell sequencing. We are also exploring spatial genomics solutions as part of our ongoing commitment to innovation.”

“At 10x Genomics, we deliver powerful, reliable tools that fuel scientific discoveries, and we’re thrilled that Almac Diagnostic Services is bringing our Chromium platform to its clients, expanding access to cutting-edge single cell technology for biopharmaceutical research,” said Everton Bačić-Robinson, Vice President, EMEA, 10x Genomics. “This collaboration will help accelerate scientific insights and advancements in biomarker research, and we’re excited to be part of that impact.”

To find out more about Almac single cell RNA Sequencing Solutions visit: https://www.almacgroup.com/diagnostics/rna-sequencing-solutions/

To find out more about 10x Genomics CSP providers visit: https://www.10xgenomics.com/service-providers

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This £55 million industry-led collaborative initiative, backed by a consortium of leading companies in Precision Medicine is also supported by leading academics from Queen’s University Belfast and Ulster University. 

Almac’s significant involvement in the new Institute, for Almac Discovery and Almac Diagnostic Services in particular, is a further demonstration of our commitment to the Life and Health Sciences Sector locally.

The FMI will also focus on skills development, leveraging the local universities and colleges to address talent gaps in the sector, foster spinouts, and drive job creation to support the broader Northern Ireland economy.  This will further help to build on Almac’s existing track record of investing in the area of skills, whether through STEM engagement, apprenticeships, placements and work experience.

Alan Armstrong, Chair and CEO of Almac Group said: “Congratulations to colleagues in Almac Discovery, Almac Diagnostic Services and Group for the central role they have played in today’s announcement of the £55m Future Medicines Institute. We look forward to working with our other industrial partners and the two universities to deliver on the potential for the life and health sciences sector that the Strength in Places project and the FMI represent for NI.” 

The industry-led consortium has been offered £35m from the Northern Ireland Executive towards FMI, with the consortium members contributing an additional £20m. This will fund a wide range of collaborative R&D activities between the companies and universities. It will also create a shared lab within Queen’s University Belfast, where industry and academics can come together to collaborate and access leading edge technologies.  

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The Almac Group has today announced details of an £80 million investment programme to build new extensive manufacturing, production and diagnostic laboratory facilities at its Global Headquarters in Craigavon, Northern Ireland.  

The construction of these two significant facilities will create over 550 jobs locally, spanning a range of lab and non-lab-based roles, with recruitment already commenced for some positions.  This is part of the company’s international recruitment drive which is expected to create 1,000 jobs in Northern Ireland over three years.

The expansion, which is part of the global investment programme announced in 2022, will significantly grow operations for two of the Group’s business units, Almac Pharma Services and Almac Diagnostic Services. 

Almac Pharma Services supports the development and commercialisation of new treatment options for a wide range of therapy areas including oncology and immunology.  Almac Diagnostic Services offers a range of biomarker discovery, development and commercialisation solutions to Biopharma partners globally.

The first of these two major projects is a 100,000ft² state-of-the-art multi-product Good Manufacturing Practice (GMP) facility for Almac Pharma Services. This Centre of Excellence for manufacturing will house a custom designed dispensary area, multiple production suites, process equipment wash facilities and a lineside warehouse for ambient, refrigerated and frozen storage.  The new facility will primarily support solid oral dose products, complementing Almac’s existing capabilities in this area.

The facility, which will be operational from Q3 2024, will expand Almac Pharma Services’ existing manufacturing capabilities and offers additional capacity for further strategic production contracts.  The high-specification production suites have been designed with flexibility and a wide range of uses in mind which offers opportunities for clients to install bespoke technology specific to their individual needs.

The second project is a 40,000 ft² four-storey diagnostic development and manufacturing centre for Almac Diagnostic Services which will be completed by Q1 2024. The new facility will enable Almac Diagnostic Services to expand its assay development offering and to manufacture and distribute Companion Diagnostic (CDx) kits on a commercial scale to support growing client demand. 

This expansion will enhance Almac’s existing early phase biomarker development capabilities through to assay development and deployment in clinical trials, cementing the company’s position in the market as a fully resourced partner of choice to pharma companies for manufacturing and commercialisation of companion diagnostics.

Alan Armstrong, Chief Executive of Almac Group said: “Almac is committed to re-investing all our profit back into the business.

“This £80 million expansion and the creation of 550 new, highly skilled jobs in Northern Ireland will ensure that we remain the global leaders in our industry, giving our clients and ultimately patients across the world who benefit from these therapeutics, the best possible offering from Almac.”

These projects have been supported by Invest Northern Ireland who have welcomed the development and ongoing expansion of the Almac Group. 

Jeremy Fitch, Executive Director of Business Growth Group, Invest Northern Ireland said: “Almac’s commitment to innovation and excellence has positioned it as a cornerstone of our region’s Life & Health Sciences success story and supported it to build a world-renowned reputation for ground-breaking work in the global pharmaceutical industry.

“We are delighted to support this investment which is creating hundreds of employment opportunities in the Armagh, Banbridge and Craigavon Borough Council area and will bolster Northern Ireland’s reputation as a hub for pharma and diagnostic development. We commend Almac’s dedication and vision and we look forward to witnessing the positive impact this investment will have on Northern Ireland’s economy and the advancement of life changing medicines.”

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This investment in the newest and most powerful instrument from Illumina enhances Almac’s NGS portfolio of DNA Sequencing Service offerings, including Whole Genome Sequencing, Whole Exome Sequencing and a range of RNA Sequencing Service offerings for Biomarker Discovery projects.

Adding the Illumina NovaSeq X Plus’s powerful processing capabilities to Almac’s existing range of NGS platform offerings will enable even larger sample runs, greater read depth, including both short and long-read sequencing and faster speeds. As a result, it will increase throughput, variant detection quality and accuracy, while reducing turnaround time and cost per sample for client biomarker research projects.

Michael Sloan, Global VP of Commercial Operations, Almac Diagnostic Services said: “Almac is at the cutting edge of NGS diagnostics. Investing in this new instrument further enhances our DNA and RNA panel offerings, opens the potential for further expansion of our NGS solutions for clients and significantly increases overall sequencing capacity, ensuring that Almac continues to play a leading role within precision medicine.”

Almac Group has committed to achieving net zero by 2045 and to reducing Scope one and Scope two emissions by 50 percent by 2030.  Illumina’s focus on sequencing sustainability to reduce impact on the environment aligns with this commitment.  The NovaSeq™ X Plus has 90 per cent less packaging weight and waste, new compact cartridges and packaging design and more recyclable plastics which helps to save on disposal costs and environmental impact.

“Almac has a record for excellence in precision medicine and we are delighted that as an important strategic partner, it’s taken delivery of the first NovaSeq™ X Plus instrument in Northern Ireland and Ireland and invested in this state-of-the-art technology to significantly expand its high-throughput sequencing capabilities,” said Mark Robinson, General Manager, UK and Ireland, Illumina. “With its new chemistry, the NovaSeq X series will enable, Almac, to maximise productivity and minimise turnaround time, with faster, more powerful, and more sustainable sequencing.”

Find out more about Almac’s range of Genomic Services.

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Almac’s clara^T, which has supported over 60 oncology studies to date for multiple Biopharma and Academic clients, classifies the most biologically relevant gene expression signatures into a comprehensive easy-to-interpret report that covers all 10 Hallmarks of Cancer. 

The updates include 16 new gene expression signatures across the Hallmarks of Cancer, improved functionality with online data access and simplified reporting through an interactive dashboard.  Clients receive a unique, interactive report that allows the easy visualisation of the key discriminating biologies within either a large cohort or an individual tumour sample.

Toshimitsu Uenaka, President EPAT (Epochal Precision Anti-Cancer Therapeutics), at Eisai Inc., whose translational team have used Almac clara^T stated: “We really found the clara^T analysis of our studies to be very informative and a useful tool for our future drug discovery.”

Adding these new gene expression signatures ensures that clara^T remains current in the market with the most up to date content available. Almac clara^T offers a unique solution in the market for biomarker discovery from either RNASeq data generated from sample profiling within Almac labs or from gene expression data sets generated elsewhere that require further bioinformatics analysis.

Professor Richard Kennedy, Global VP and Medical Director, Almac Diagnostic Services said: “Being able to equip leading Biopharma and academic cancer researchers globally with a powerful gene expression analysis platform has supported the identification of exciting new data.

“Conventionally gene expression signatures are applied individually to classify patients into molecular subgroups.  Signatures designed to identify the same biology are often developed independently using different bioinformatics algorithms and therefore may not classify identically.  To address this, we developed the clara^T software solution which uses consensus between multiple published signatures, categorised into the Hallmarks of Cancer, to classify cancers in a more robust manner. Importantly, this standardised bioinformatics approach enables the analysis of datasets in a highly reproducible and cost-effective offering.

“Our proprietary clara^T report has demonstrated its ability to accelerate mRNA-based research, enabling deeper insights into translational cohorts which leads to better drug development and trial stratification, potentially contributing to better patient outcomes in the future.”

Almac Diagnostic Services is hosting a GenomeWeb Webinar on Tuesday 13^th June alongside leading cancer researchers from the University of Kansas, USA.  The webinar will focus on how clara^T was utilised effectively within breast cancer studies. 

The LIVE webinar will be held at 11am EDT / 4pm BST and interested parties can sign up here.

To find out more about Almac clara^T visit: www.almacgroup.com/diagnostics/claratreport 

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Read Almac Diagnostic Services recent genomeweb feature on our CDx collaboration with AstraZeneca in multiple chronic disease indications.

In this article, written by Justin Petrone, hear from Almac on why companion diagnostics business has always been a core service for Almac and how the change in technology focus towards qPCR and Next Generation Sequencing (NGS) is increasing with market demand.

Hear from AstraZeneca, where a precision medicine approach is an integral part of the company’s R&D efforts to develop precision medicines for chronic diseases that make it possible to diagnose and intervene earlier.

Access the full article here.

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Almac Diagnostic Services, a member of the Almac Group, today announced it has signed a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialise multiple companion diagnostic (CDx) products. Almac will work to support AstraZeneca in its drive to bring new therapies to patients globally in disease areas of high unmet need.

Under the terms of the agreement, Almac will develop and validate specific CDx assays for patient selection in various AstraZeneca clinical trials across a range of therapeutic areas including kidney disease, non-alcoholic steatohepatitis, and respiratory disease. Almac will seek regulatory approval for individual CDx assays in agreed jurisdictions in tandem with linked AstraZeneca therapeutics. To date, a number of programmes have already been initiated under this model.

Professor Paul Harkin, President & Managing Director, Almac Diagnostic Services, commented: “We are delighted to have signed this CDx master collaboration agreement, which represents a further strategic alignment with AstraZeneca, and enhancement of an already strong relationship. We are looking forward to working collaboratively together to develop and commercialise these companion diagnostic tests to help identify the right patient populations that will benefit from future AstraZeneca targeted therapies.”

Maria Orr, Head of Precision Medicine, BioPharmaceuticals R&D, AstraZeneca said: “Precision medicine is at the heart of AstraZeneca’s ambition to dramatically improve patients’ lives globally; it is an interconnected cycle from early research, innovative pharmacology and drug modalities, to clinical trial design and diagnostic development. Through collaborating with our partners we can lead the way in a new era of precision medicines for complex chronic diseases. We are committed to matching life-changing medicines to patients most likely to benefit and we believe our collaboration with Almac will help us achieve this.” 

ENDS

——-

Notes to editors

About Almac Group

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,500 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

For media enquiries:

Julie Watts, Almac Group, julie.watts@almacgroup.com

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Craigavon, N.I., Wednesday 8 December 2021 – Almac Diagnostic Services, a member of the Almac Group, is delighted to announce that its unique software driven solution for gene expression data analysis – claraT – has assisted oncology researchers at The University of Arkansas for Medical Sciences (US) and Queen’s University Belfast (UK) in the study of brain and breast cancers. The studies, recently published in the MDPI Cancer Journal and the British Journal of Cancer, have the potential to lead to better therapeutic outcomes for patients.

The research teams, led by Dr Analiz Rodriguez at the University of Arkansas for Medical Sciences and Dr Stuart McIntosh at Queen’s University Belfast, cite use of Almac’s claraT report as a key method used to uncover new findings in their oncology studies.

Almac’s claraT report assists in the analysis of gene expression data by classifying the most biologically relevant gene expression signatures into a comprehensive easy-to-interpret report that covers all 10 Hallmarks of Cancer.

In Dr Analiz Rodriguez’s study, claraT was utilised as a method to facilitate the molecular profiling of brain metastases. Together with other genomic and transcriptomic tools, claraT helped identify novel molecular subtypes and new drivers of brain cancer progression in parallel to novel drug targets. These findings have been published in the MDPI Cancer Journal.

Dr Rodriguez said “We are grateful for the Almac Group’s claraT platform as it allowed us to evaluate hundreds of gene expression signatures and single gene targets that correlated to the Hallmarks of Cancer. Transcriptome data can be difficult to analyze, especially in our heterogenous dataset which included brain metastases samples from various primary cancer subtypes. The claraT software solution immensely simplified our workflow and helped us identify a novel subgroup of brain metastases which warrants further investigation.”

Dr McIntosh’s study at Queen’s University Belfast demonstrated that the Almac DNA-damage immune-response (DDIR) assay could be used to identify a group of breast cancer patients more likely to benefit from DNA damaging chemotherapy prior to surgery. The team then used transcriptome profiling and the claraT report to demonstrate that patients with low baseline immune signalling or “cold” tumours could be immune primed through the prior use of DNA damaging chemotherapy, potentially sensitizing these tumours to immune checkpoint therapy. Taken together, these results could help refine the treatment of breast cancer patients and lead to better therapeutic outcomes. These results have been published in the British Journal of Cancer.

Dr McIntosh said “The increasing use of neoadjuvant chemotherapy for breast cancer has great potential to benefit patients, but there is a real need for validated biomarkers to identify those patients who will benefit from it. Furthermore, although there is increasing interest in the use of immune checkpoint therapies in breast cancer, we still don’t know which patients are likely to respond, nor what the best accompanying chemotherapeutic regimen is to sensitise patients to these. The use of Almac’s claraT report in our study has given us a valuable insight into the underlying biology of breast tumours before and during neoadjuvant chemotherapy, allowing us the potential to develop studies with a sound scientific rationale to further improve outcomes for these women.”

Professor Richard Kennedy, Global VP and Medical Director, Almac Diagnostic Services stated: “We are delighted to be able to equip leading cancer researchers like Professor Rodriguez and Dr McIntosh with a valuable gene expression analysis platform which has supported the identification of exciting new data in their studies. We congratulate them and their teams on their recent publications and look forward to seeing how their studies progress towards new therapeutic interventions in both brain and breast cancer.”

To see the current list of publications, posters and presentations that Almac’s claraT report has assisted research institutions with. Please see: https://www.almacgroup.com/diagnostics/claratreport/publications

ENDS

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Bringing together academia, industry and healthcare stakeholders, this unique collaboration creates alignment of academic insight and industrial capability in the field of personalised medicine. As part of the Innovate UK funded Innovation Scholar award, the appointment will see Dr Turkington, who is currently Clinical Senior Lecturer in Medical Oncology at the Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast and an Honorary Consultant at the Northern Ireland Cancer Centre, join the Almac team for three years.

As medicine is transitioning from a ‘one-size-fits-all’ approach to more personalised treatments, it is clear more robust biomarker tests are needed to guide treatment decisions. Richard has over 10 years’ experience in personalised medicine and leads an academic research group focussed on improving outcomes for patients with oesophageal and gastric cancer through biomarker-led clinical trials. During his tenure, Dr Turkington will be integral to the validation of new biomarkers and their implementation in international clinical trials in collaboration with Almac’s pharmaceutical industrial clients.

He commented: “I am delighted to join the team at Almac Diagnostic Services and hope that the array of experience I have can help build upon the excellent foundations that are already in place. As a biomarker expert and clinical triallist, the addition of my role will enhance the excellent research and development carried out by Almac Diagnostic Services in biomarkers and support our goal of providing personalised treatment for patients globally.”

Professor Paul Harkin, Managing Director & President, Almac Diagnostic Services said: “Dr Turkington’s wealth of experience and insight into precision medicine is a true asset to our team and we are delighted that he is joining us. His unique position will see him working at the intersection of academia and industry which will benefit the wider healthcare infrastructure and ultimately patients by providing effective, precise and tailored treatments.”

ENDS

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PGDx and Almac Diagnostic Services will focus on providing access to tumor profiling assays for both tissue and plasma samples, specifically, PGDx elio™ tissue complete and PGDx elio™ plasma resolve. This collaboration will combine Almac’s world-class genomics services and expertise in development and delivery of molecular diagnostics with PGDx’s leadership in cancer genomics to accelerate solutions that will deliver precision medicine to more patients. 

“We are proud to enter into this strategic collaboration with Almac. Their longstanding reputation for providing high quality lab services to patients worldwide, along with their proven track record of implementing new technologies make this partnership ideal,” said Megan Bailey, CEO, PGDx. “As we continue our quest to empower the fight against cancer, collaborating with Almac will allow us to deliver precision medicine solutions to a broader population and advance innovations in next-generation sequencing technology.”

Michael Sloan, Global Vice President of Commercial Operations, Almac Diagnostic Services said: “This collaboration with PGDx will enable Almac to provide our Pharmaceutical and Biotech partners with tissue and liquid biopsy options to support their translational research, clinical trials and CDx development requirements.  The assay panels PGDx have developed will allow our clients to access world-class next generation sequencing science and bioinformatics solutions.”

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by researchers from Johns Hopkins University who are pioneers in cancer genome sequencing and liquid biopsy technologies. For additional information, visit www.pgdx.com.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specialising in biomarker driven clinical trials. The company is focused on the discovery, development and commercialisation of diagnostic and companion diagnostic tests.

We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs.

The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics.

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

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Craigavon, N.I., 20 Jul 2020 – Almac Diagnostic Services, a member of the Almac Group, is pleased to announce the winners of its inaugural clara^T* ‘Grant Programme for Academic Cancer Researchers’. Worth

$287,000 of data analysis in total across all winners, ten selected research institutions globally will now each have the chance to utilise Almac’s clara^T software solution to further their gene expression cancer research projects.

Academic research scientists may not always have access to expertise in the comprehensive analysis of gene expression data, which could ultimately help fast-track biomarker discovery and translational research.

Almac invited global academic research scientists, with an oncology focus, who had access to good quality gene expression data, to submit applications providing details of their project and how clara^T could benefit their cancer research efforts.

The 10 successful grant recipients are:

The full Academic institution information and Academic researcher titles can be found here: https://www.almacgroup.com/diagnostics/claratreport/almac-clarat-grant-programme-for-academia/

Professor Richard Kennedy, Almac Diagnostic Services’ Global VP of Biomarker Development & Medical Director, commented: “Congratulations to all the successful Almac grant recipients. We wish them every success as they continue their research efforts, new discoveries and future publications. Almac are delighted to play a part in that journey. We are pleased to be able to offer this opportunity to cancer research scientists where Almac will cover the costs associated with utilising clara^T to help classify gene expression data. Ultimately, with a view to better understanding the significance of the underlying biologies, which could lead to novel combination or targeted therapies in the future.”

Grant applications were received from across the US, Canada and Europe. All submissions were reviewed by a multidisciplinary scientific review panel, highly experienced within the cancer research field. The review panel, comprised of Dr Kienan Savage from Queen’s University Belfast PGJCC (The Patrick G Johnston Centre for Cancer Research), Almac’s Dr Laura Knight, Global VP of Data Sciences and Dr Nuala McCabe, Biomarker Research Manager, ranked and selected the winning grant projects based on the submission pre-defined selection criteria. Applications were assessed on the study design, the translational significance & the potential to generate data for publication within a year.

Each recipient will be given the opportunity to use Almac’s innovative clara^T software solution which provides a concise, easy to interpret report ,with over twelve months of bioinformatic analysis in just a couple of days. Almac clara^T reads out 92 unique gene expression signatures across all 10 Hallmarks of Cancer^ – A process which typically requires deep technical expertise and significant time & money investment.

One winner, Dr Wei Zhang, Associate Professor, Department of Preventative Medicine, from Northwestern University Feinberg School of Medicine (Chicago, USA), upon receiving the Almac grant award, stated what this would mean for their research: “Having won this Almac grant award, we are very pleased to have an opportunity to utilise an innovative tool that could provide us with novel insights into gene networks and pathways that are related to glioblastoma and patient survival.”

Further information on Almac clara^T Total mRNA Report can be found here: almacgroup.com/diagnostics/claratreport

* clara^T is a unique software driven solution, classifying the most biologically relevant gene expression signatures into a comprehensive easy-to-interpret report. Note: clara^T is for research use only (RUO) and is not to be used for diagnostic or prognostic purposes, including predicting responsiveness to a particular therapy.

^ The Hallmarks of Cancer, originally published in Cell 144, Hanahan & Weinberg, Hallmarks of Cancer. The Next Generation, 646-674, © 2011.

ENDS

Notes to editors

About Almac Group

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Announces Winners of claraT Grant Programme for Academia appeared first on Almac.

Craigavon, U.K., 24 April 2020 – Bringing comprehensive genomic profiling (CGP) one step closer to the standard of care in oncology, Illumina is now shipping TruSight™ Oncology 500 ctDNA (TSO 500 ctDNA), our first liquid biopsy solution for detecting cancer biomarkers, and TruSight Oncology 500 High-Throughput (TSO 500 HT), enabling high-throughput implementation by large labs with high-volume tissue sample needs. TSO 500 ctDNA and TSO 500 HT provide labs with the flexibility to run tissue or blood plasma samples on a single high-throughput platform, the NovaSeq™ 6000 Sequencing System. These two new additions join the TruSight Oncology 500 (TSO 500) family – the tissue-based version of the assay, which is optimized for both the NextSeq 550 and NextSeq 550Dx Systems. TruSight Oncology 500 products are currently intended for research use only (RUO).

TSO 500 ctDNA enables non-invasive, comprehensive genomic profiling of circulating tumor DNA (ctDNA) when tissue testing is not optimal, or to complement tissue-based testing. TSO 500 ctDNA is one of the first liquid biopsy assays to enable comprehensive genomic profiling that interrogates the sequence of 523 genes in key cancer-related pathways, including single-nucleotide variants (SNVs), Indels, copy-number variants (CNVs), fusions, microsatellite instability (MSI) and tumor mutational burden (TMB).

Optimized for the NovaSeq 6000, TSO 500 ctDNA offers both the economic value and the scale of sequencing needed to properly interrogate ctDNA at high levels of sensitivity and specificity. Complementing TSO 500 ctDNA on the NovaSeq 6000 is TSO 500 HT, providing large labs the ability to perform CGP analysis of up to 192 FFPE samples at a time, in a single NovaSeq sequencing run. Additionally, the two assays offer comprehensive coverage including a majority of the known and anticipated biomarkers associated with guidelines and clinical trials.

“We believe in the advancement of personalized medicine guided by molecular-based testing to improve patient outcomes,” said Margot P. Schoenborn, CEO of OmniSeq, Inc. “TSO 500 HT gives us the scalability to process a large number of samples every week, in that we can batch from 16 to 192 samples in a single run on the NovaSeq. Having the flexibility to run multiple flow cell options will enable us to optimize sequencing runs based on clinical volumes and flexibility to meet the turnaround time requirements of our customers.”

By offering solutions that independently interrogate both tissue and liquid biopsies on the NovaSeq 6000, Illumina’s TSO 500 portfolio enables a complete solution of in-house quality comprehensive genomic profiling assays, providing customers with:

• Flexibility and efficiency to deploy the same oncology panel, on the same sequencing platform, regardless of sample type
• Ability to run comparability of results in tissue and blood from a single individual, or across individuals
• Scalability to meet high-throughput lab requirements

“Comprehensive genomic profiling on the DNA- and RNA- level will play an increasing role for cancer precision medicine,” said Professor Albrecht Stenzinger, MD, from the Institute of Pathology at University Hospital in Heidelberg, Germany. “There is a growing number of drug targets, as well as an emerging landscape of resistance mechanisms, that will make large panels, which I define as panels with more than 1 Megabase genomic footprint, not the exception, but the norm. High quality data with low TAT will be crucial in this context,” he concluded.

Offering an impressive sample-to-answer workflow, with a five-day turn-around time

Secondary analysis of large liquid biopsy CGP panels can be challenging. To address this issue, TSO 500 ctDNA utilizes the Illumina DRAGEN^TM  (Dynamic Read Analysis for GENomics) Bio-IT Platform to provide accurate and ultra-rapid secondary analysis of sequencing data. TSO 500 ctDNA leverages the combination of the DRAGEN Bio-IT server hardware and DRAGEN TruSight Oncology 500 ctDNA Analysis Software to offer an accelerated, easy-to-implement, fully integrated set of bioinformatics algorithms to overcome ctDNA challenges, and ensure optimal assay performance. This is important because it provides robust and accelerated comprehensive variant calling, at very low limits of detection, in a single solution.

Dr. Steven Walker, Head of Product Development, Almac Diagnostic Services said: “This innovate product from Illumina will enable Almac to provide Pharmaceutical and Biotech companies with a new liquid biopsy option to support their translational research, clinical trials and CDx development. The assay, based on the TSO 500 platform, allows the mutational assessment of 523 genes from a single liquid biopsy sample. Integration of the Illumina DRAGEN™ Bio-IT platform into the workflow will help to significantly reduce the turnaround time for complex data analysis for our clients. 

He continued: “Almac sees this product as a key component in our broad range of biomarker solutions. From the pharma or biotech perspective, this platform will enable biomarker discovery and testing from non-invasive samples, rather than typical tumor biopsy based methods which can be challenging. We believe this large panel and powerful analysis platform will enable our clients to effectively develop exciting new biomarkers for novel therapeutics.”

The TSO 500 menu, including TSO 500, TSO 500 ctDNA [WL1] and TSO 500 HT offer Pierian Dx’s streamlined tertiary interpretation and reporting, from their Clinical Genomics Workspace (CGW) platform. Powered by a comprehensive Clinical Genomics Knowledgebase, CGW gives customers the ability to identify and categorize pathogenic variants, and build a final annotated interpretation report. The combination of Illumina’s comprehensive tumor profiling assays coupled with DRAGEN and PierianDx’s variant interpretation and reporting solutions provides customers with a seamless and semi-automated workflow, from sample to final report.

Read Chief Medical Officer, Phil Febbo’s, perspective on the power and promise of liquid biopsies here. For more information on TSO 500 ctDNA and TSO 500 High-Throughput, click here.

###

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post TruSight Oncology Family Grows with Liquid Biopsy and High-Throughput Assay Additions appeared first on Almac.

Craigavon, N.I., 26 September 2019 – Almac Diagnostic Services, a member of the Almac Group, will launch the complete version of clara^T* at the ESMO Congress in Barcelona on 27th September.

The Almac clara^T Total mRNA Report content has expanded considerably from the initial version launched the previous year at the ESMO Congress. The complete version now includes 92 gene expression signatures, 100 single gene drug targets and over 7,000 additional biology linked genes, categorised by all 10 Hallmarks of Cancer.

The innovative clara^T Total mRNA Report benefits both academic and biopharma biomarker discovery and translational researchers by saving them valuable time in analysing gene expression data and helping to maximise the understanding of their dataset. clara^T analyses multiple published gene expression signatures that represent the Hallmarks of Cancer simultaneously, and presents the results in a comprehensive, easy-to-interpret format. Researchers are provided with an interactive report that facilitates easy visualisation of novel molecular subgroups within the sample cohort and the key discriminating biologies within an individual tumour sample.

By allowing multiple biologies to be evaluated in parallel, as opposed to the traditional method of focusing on one biology alone, the clara^T Total mRNA Report supports the identification of novel insights, highlighting consensus signatures within, and between, the Hallmarks of Cancer. This analysis allows researchers to confirm known findings in the field, but more importantly helps to identify new and unique observations such as novel pathways and biologies predicting response to therapeutic targets that may not yet be proven to do so.

One such researcher who has benefited from using Almac’s solution is Priyanka Sharma MD, Professor of Medicine at The University of Kansas Medical Centre & Vice Chair of the Breast Committee at South Western Oncology Group (SWOG). Dr Sharma stated: “RNA sequencing is a valuable tool for interpreting the gene expression shifts that occur in tumors as a result of cancer therapy. We recently used Almac’s innovative gene expression analysis tool, clara^T, to simultaneously assess multiple biologies in a breast cancer clinical trial cohort. clara^T analysis revealed the specific Hallmarks of Cancer and novel expression signatures that are directly associated with treatment response in this trial involving a drug targeting the PI3K pathway. We anticipate that these exciting new findings may guide future clinical trial design and patient selection criteria.”

RNA-Sequencing (RNA-Seq) data is complex and difficult to interpret, often requiring extensive bioinformatic capabilities. Almac has developed an optimised RNA-Seq platform alongside proprietary bioinformatics pipelines and software solutions to report and visualise this myriad of data in an intelligently simplified manner.

Professor Richard Kennedy, Global VP of Biomarker Discovery, Almac Diagnostic Services stated: “We are delighted to be able to assist leading cancer researchers like Dr Sharma with identifying exciting new data and look forward to the results being published in the near future. Our proprietary clara^T report has only been on the market for twelve months but has already generated considerable interest and has been adopted by some leading pharma companies and academic researchers for gene expression analysis. It has demonstrated its ability to accelerate RNA-based biomarker research, enabling deeper insights into translational cohorts for better trial stratification and potentially improving patient outcomes in the future.”

For further information on clara^T click here.

To discuss your RNA biomarker research project requirements and how clara^T can help, visit the Almac booth #473 at ESMO 2019.

*NOTE: The results displayed in the clara^T report are for research use only (RUO) and are not to be used for diagnostic or prognostic purposes, including predicting responsiveness to a particular therapy.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials.

Click here for more information.

About Almac Group
A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac’s unique gene expression report enables cancer researchers to discover exciting new insights appeared first on Almac.

Craigavon, N.I., 31 July 2019 – Almac Diagnostic Services, a global stratified medicine company and member of the Almac Group, today announced the launch of its Sample Management Service. 

This latest support offering includes pathology review & digital pathology, sample receipt and accessioning, sample storage and downstream processing. The service provides clients with the reassurance that samples are being stored safely, with reliable up-to-date information about sample inventory, ultimately enabling ready access to samples upon request.

Almac Diagnostic Services has over 15 years’ experience in sample preparation, analysis and reporting and as part of the Sample Management Service, offers a dedicated point of contact throughout an entire project.  This, coupled with Almac’s unique LIMS barcode system, ensures sample traceability and full chain of custody, alongside bespoke data management reporting to suit client’s exact requirements.

A range of secure storage solutions are available at Almac Diagnostic Services’ facilities to suit individual study needs including ambient and cold storage which are temperature controlled, fully validated and HTA compliant, and monitored 24/7.

Whether clients are benefitting from Almac Diagnostic Services’ downstream sample processing services such as DNA/RNA extraction, DNA panel /RNA panel Next Generation Sequencing, Whole Exome Sequencing (WES) or if they require the analysis to be performed externally with another vendor, the new Sample Management Service helps coordinate these activities on the client’s behalf.

Dr Leeona Galligan, VP UK Operations, Almac Diagnostic Services, commented “The addition of this Sample Management Service to our growing portfolio of service offerings is further evidence of our commitment to provide a fully integrated laboratory service to our global biopharma client base.  We have established a dedicated team to deliver this offering which will ultimately help simplify and streamline the clinical trial process for our customers and I am delighted to launch this new service.”

To find out more about Almac Diagnostic Services’ Sample Management Service, please visit:

https://www.almacgroup.com/diagnostics/clinical-trial-solutions/sample-management/

#END#

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specialising in biomarker driven clinical trials. The company is focused on the discovery, development and commercialisation of diagnostic and companion diagnostic tests.

We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs.

The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics. 

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Diagnostic Services Launches Sample Management Service appeared first on Almac.

Craigavon, N.I., 05 June 2019 – Almac Diagnostic Services, a global stratified medicine company and member of the Almac Group, today announced the successful CE marking of the diagnostic assay that will be used to determine molecular eligibility for enrolment into the pivotal Phase 2 portion of Turning Point Therapeutics’ TRIDENT-1 clinical trial.

The next-generation sequencing (NGS) assay is intended for use in identifying patients with ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumours.

Commenting on the CE mark, Stewart McWilliams, Global VP of Quality & Regulatory Affairs at Almac Diagnostic Services said: “CE marking of the assay allows it to be utilised for screening trial subjects for enrolment.  In addition, it provides quality assurance of the assay’s analytical performance and demonstrates that the product meets the essential requirements of the European In Vitro Diagnostic Directive 98/79/EC for its intended use.”

This important milestone follows swiftly on from the recent announcement by Turning Point Therapeutics and Almac Diagnostic Services of the US Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) approval of the assay. The CE marking of the assay evidences the further utility of the test to support the European portion of the global TRIDENT-1 clinical study.

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI), developed for the treatment of patients with advanced solid tumours harbouring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Turning Point Therapeutics’ TRIDENT-1 Phase 2 open-label, multi-cohort study is planned for initiation in the second half of 2019.

“Each milestone in our development of repotrectinib brings us one step closer to the ultimate goal of reaching global patients with new therapeutic options for their cancer,” said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point Therapeutics. “We are pleased to gain the CE Mark for the companion diagnostic assay as we continue our planning to initiate the global Phase 2 portion of Trident-1.”

#END#

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specialising in biomarker driven clinical trials. The company is focused on the discovery, development and commercialisation of diagnostic and companion diagnostic tests.

We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs.

The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics. 

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

About Turning Point Therapeutics Inc.

Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients, and is planned to enter a registrational Phase 2 study in the second half of 2019. Turning Point’s kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.

For more information, visit www.tptherapeutics.com.

The post Almac Group Announces CE Mark of Diagnostic Assay to Support Turning Point Therapeutics’ Pivotal TRIDENT-1 Clinical Trial appeared first on Almac.

The next-generation sequencing (NGS) assay is intended for use in identifying patients with ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors. Clinical investigators will use the diagnostic test to determine molecular eligibility for enrollment into Turning Point’s registrational Phase 2 portion of the global TRIDENT-1 clinical study.

“We are pleased to achieve this important milestone with our partner Almac, moving us closer to the start of our pivotal study for repotrectinib in the second half of 2019,” said Athena Countouriotis, M.D., president and chief executive officer. “With a clear unmet medical need for therapies that target genomic alterations in different cancers, the diagnostic assay will provide clinical investigators with timely information to confirm the presence of the oncogenic drivers we continue to study in patients with advanced solid tumors.”

Almac has been developing the NGS diagnostic based on Archer Dx’s Anchored Multiplex PCR (AMP™) chemistry, with the intent of submitting it for regulatory approval in the United States and using it initially at Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

“We are very pleased to have been granted IDE approval by the FDA for the development and validation of this complex NGS diagnostic assay for its intended use as a clinical trial assay,” said Paul Harkin, President & Managing Director, Almac Diagnostic Services. “We are delighted to assist Turning Point Therapeutics with this important upcoming clinical study, and furthering our partnership to progress such a promising investigational therapy as repotrectinib.”

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Turning Point Therapeutics’ TRIDENT-1 Phase 2 open-label, multi-cohort study is planned for initiation in the second half of 2019.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. Almac partners with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. Almac also facilitates biomarker clinical trial management and clinical test delivery from its CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials. For more information visit: almacgroup.com/diagnostics 

About Turning Point Therapeutics Inc.

Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients, and is planned to enter a registrational Phase 2 study in the second half of 2019. Turning Point’s kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, and the other risks described in Turning Point Therapeutics’ filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

ENDS

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Turning Point Therapeutics and Almac Diagnostic Services announce approval of an investigational device exemption for the companion diagnostic assay to the registrational TRIDENT-1 clinical study appeared first on Almac.

Current treatment for oesophageal cancer involves a course of standard chemotherapy aiming to reduce the tumour size before follow-up surgery can be carried out to remove it. Only around 20 per cent of tumours will reduce in size following the standard course of chemotherapy. For oncologists identifying the most effective chemotherapy to reduce the size of oesophageal tumours before they are operated on is a challenge.

Dr Richard Turkington, Senior Clinical Lecturer at Queen’s University Belfast, and lead author on the study explains: “The UK has the highest incidence in the world of a particular type of oesophageal cancer called oesophageal adenocarcinoma, with 16,000 cases each year.  One-third of patients are diagnosed with tumours which have not spread and can be removed by surgery following a course of chemotherapy.  However, less than one in five patients show evidence of shrinkage from the chemotherapy when their tumour is removed.”

“In order to cure more oesophageal cancers we need to identify the most effective treatment for each patient to give them the best chance of all of their cancer being removed.  At present we apply a ‘one-size-fits-all’ approach where everyone gets the same type of chemotherapy before their surgery. But we know that different chemotherapies work better for different patients so we need to match the right treatment to the right patient.  This test enabled us to gain a molecular understanding of each patient’s cancer, which could then inform the decision to select the right chemotherapy to shrink the tumour.”

Queen’s has collaborated with Almac Diagnostic Services to bring personalised medicine to oesophageal cancer.  Almac Diagnostic Services has previously developed the DNA Damage Immune Response (DDIR) Signature, previously known as DDRD, to personalise chemotherapy for breast cancer but further studies indicated that it may be applied to other cancer types.  The DDIR Signature is a 44 gene signature which uses the expression of each gene present in each tumour to generate a score for each patient.  A high score indicates that the tumour has a higher likelihood of responding to DNA damaging chemotherapies.

Professor Richard Kennedy, McClay Professor of Medical Oncology at Queen’s University Belfast and Global Vice-president of Biomarker Development at Almac Diagnostic Services commented: “This study highlights the benefits of close collaboration between academia and industry and the strong links between Queen’s and Almac in particular.  It expands the indications for the DDIR signature to oesophageal adenocarcinoma and brings stratified medicine a step closer in this difficult to treat cancer.”

This research study is part of the Oesophageal Cancer Clinical and Molecular Stratification (OCCAMS) consortium led by Professor Rebecca Fitzgerald from the Medical Research Council Cancer Unit at the University of Cambridge and funded by Cancer Research UK. 

Professor Fitzgerald commented: “The OCCAMS collaboration is a UK wide network of centres for the collection of tissue samples and clinical information to study the biology and treatment of oesophageal cancer.  A key aim of the consortium is to translate laboratory discoveries into clinical progress and this study is an example of using this knowledge to improve diagnosis and treatment for oesophageal cancer patients.”

The research has been published in the prestigious journal Gut, one of the highest ranking gastroenterology journals in the world and is freely available to the research community.  The research team is continuing to test the assay further in other sample collections and through clinical trials.

The research paper is available from the journal Gut here.

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Partner with Queen’s Researchers to pioneer potentially life-changing oesophageal cancer test appeared first on Almac.

Craigavon, N.I., 27 March 2019 – Almac Diagnostic Services, a member of the Almac Group, will launch its second iteration of clara^T* at AACR in Atlanta on 29 March.  The clara^T report is a unique software-driven solution, classifying biologically relevant gene expression signatures into a comprehensive report and classifies using the Hallmarks of Cancer for easy interpretation – saving oncology researchers’ valuable time, whilst maximising the understanding of their dataset.

The new version content now includes 62 gene expression signatures and 60 single gene drug targets, in addition to almost 4,000 other biology linked genes.

The content has expanded from the first three hallmark biologies launched at ESMO 2018: Avoiding Immune Destruction, Activating Invasion and Metastasis and Inducing Angiogenesis. Almac has now enhanced the clara^T report further by upgrading three additional hallmark biologies: Genome Instability & Mutation, Sustaining Proliferative Signalling and Resisting Cell Death. Almac will continue to grow the clara^T report by developing content to eventually cover all 10 Hallmarks of Cancer by the end of the year.

The clara^T report benefits Academic and BioPharma biomarker discovery and translational research. Clients are provided with an interactive report that allows the easy visualisation of the key discriminating biologies within both the study cohort and an individual tumour sample.

The clara^T report is a pan-cancer solution generated from raw gene expression data, utilising Almac’s RNA-Sequencing Service. RNA-Sequencing data is extremely complex and difficult to interpret, often requiring extensive bioinformatics expertise. Almac has developed proprietary bioinformatics pipelines to report this complex data through clara^T in a simplified manner, helping to save time and maximise the understanding of any dataset more quickly.

Richard Kennedy, Global VP of Biomarker Discovery, Almac Diagnostic Services stated: “Conventionally gene expression signatures are applied individually to classify patients into molecular subgroups. Signatures designed to identify the same biology are often developed independently using different bioinformatics algorithms and therefore may not classify identically.

In order to address this, we developed the clara^T software solution which uses consensus between multiple published and Almac proprietary gene signatures, categorised into the Hallmarks of Cancer, to classify cancers in a more robust manner. Importantly this standardised bioinformatics approach enables the analysis of datasets in a highly reproducible and cost effective offering.”

For further information on clara^T visit almacgroup.com/diagnostics/claratreport.  

To discuss your RNA research project requirements and how clara^T can help, visit the Almac stand #3225 at AACR 2019.

*NOTE: The results displayed in the clara^T report are for research use only (RUO) and are not to be used for diagnostic or prognostic purposes, including predicting responsiveness to a particular therapy.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics. 

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group Launches Upgraded Version of claraT – A Unique, Software-driven Gene Expression Report appeared first on Almac.

San Diego, CA, October 24, 2018 – TP Therapeutics, a clinical-stage precision oncology company developing novel drugs that address treatment resistance, and Almac Diagnostic Services, a global precision medicine company, today announced a global collaboration agreement to develop and commercialize a next-generation sequencing (NGS) companion diagnostic (CDx) for repotrectinib, TP Therapeutics’ investigational therapy rationally designed to target ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors.

Under the agreement, Almac will develop the NGS diagnostic based on the ArcherDx’s Anchored Multiplex PCR (AMP™) chemistry, with the intent of submitting it for regulatory approval in the United States. The companion diagnostic will initially allow Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

“Almac provides us with deep experience in the development and regulatory approval of next-generation sequencing diagnostic assays, which will enable the selection of patients who may not otherwise have access to a targeted therapy like repotrectinib,” said Dr. J Jean Cui, founder, president and chief scientific officer of TP Therapeutics.  “We look forward to working with Almac to co-develop repotrectinib with a next generation sequencing based companion diagnostic that detects the presence of ROS1, NTRK1-3 and ALK gene fusions.”

“Molecular testing is critical to identifying patients most likely to benefit from a targeted treatment,” said Paul Harkin, managing director, Almac Diagnostic Services. “We have great expertise in the development of biomarker assays across a wide range of technologies and targets, with an extensive track-record in developing and validating assays under design control and according to regulatory requirements. We are very pleased to work with TP Therapeutics on such a promising investigational therapy as repotrectinib.”

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Co-development of CDx and therapeutic products is critical to the advancement of targeted therapies and precision medicine. Companion diagnostics are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual molecular characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may help generate more effective treatments with improved safety profiles for patients.

The financial terms of the agreement were not disclosed.

###

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics. 

About Repotrectinib (TPX-0005)

Repotrectinib (TPX-0005) is a potent and orally bioavailable investigational small-molecule inhibitor of ALK, ROS1 and TRK family kinases. The clinical benefits of targeting ALK, ROS1 or TRK fusion kinases have been demonstrated with multiple kinase inhibitors already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), in addition to crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. The successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. Repotrectinib has demonstrated potency against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple lines of treatment. Repotrectinib may provide a new opportunity to inhibit the abnormal signaling of ALK, ROS1, or TRK family kinases in solid malignancies, and overcome multiple resistance mechanisms seen in refractory patients. Repotrectinib is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1 study, www.clinicaltrials.gov number NCT03093116). Interested patients and physicians can contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email clinical@tptherapeutics.com.

1Note: TPX-0005 had an initial generic name of “ropotrectinib,” which was later changed to repotrectinib and is now the accepted name by USAN and WHO INN.

About TP Therapeutics Inc.

TP Therapeutics is a clinical-stage precision oncology company forging a new path for targeted cancer care. Founded in October 2013 by Dr. J. Jean Cui, the lead inventor of Pfizer’s oncology drugs crizotinib and lorlatinib, the company is developing a pipeline of novel drugs that aim to tackle treatment resistance and give new hope to patients who have stopped responding to available targeted therapies. Mounting clinical data for the company’s lead program, a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors, has shown ongoing antitumor activity and durable responses among treatment-naïve and pre-treated patients. With additional programs underway to address similarly intractable oncogenic drivers, TP Therapeutics is marking a turning point in the way solid-tumor cancers are treated. For more information, visit www.tptherapeutics.com.

TP Therapeutics Investor and Media Contact:

Jason Spark

Canale Communications

619-849-6005

jason@canalecomm.com

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post TP Therapeutics and Almac Diagnostic Services Enter into Agreement to Develop Next-Generation Sequencing, Pan-Cancer Companion Diagnostic appeared first on Almac.

The clara^T report will benefit BioPharma and Academic biomarker discovery and translational research. Clients are provided with an interactive report that allows the easy visualisation of the key discriminating biologies within both the study cohort and an individual tumour sample.

clara^T classifies relevant published gene expression signatures, alongside Almac’s own proprietary assays and single gene targets linked to multiple key biologies, according to the well-established 10 Hallmarks of Cancer. The clara^T report is a pan-cancer solution generated from raw gene expression data, utilising Almac’s RNA-Sequencing Service.

RNA-Sequencing data is extremely complex and difficult to interpret, often requiring extensive bioinformatics expertise. Almac has developed proprietary bioinformatics pipelines to report this complex data through clara^T in a simplified manner, helping to save time and maximise the understanding of any dataset more quickly.

The clara^T report classifies using the Hallmarks of Cancer for easy interpretation. Initial launch content includes 35 gene expression signatures and 30 single gene drug targets (in addition to other biology linked genes). The first three featured hallmark biologies included are: immuno-oncology (IO), epithelial to mesenchymal transition (EMT) and angiogenesis. Almac will continue to expand the clara^T report by developing content to ultimately cover all 10 Hallmarks of Cancer.

Michael Sloan, Global VP of Commercial Operations, Almac Diagnostic Services stated:

“RNA-Sequencing produces vast amounts of complex raw data that can be difficult to interpret. We believe clara^T offers a unique and highly cost-effective solution to this problem for BioPharma clients. From a single tumour sample sent to Almac’s labs, clara^T provides multiple biologically relevant signature readouts in an easy to interpret report, saving time and allowing researchers to identify key patterns of gene expression within their cohort.

“clara^T further enhances Almac Diagnostic Services’ capabilities within RNA expression profiling. The value of RNA alongside DNA in stratified medicine is slowly starting to be realised and Almac are hoping to provide further proof of its importance with our clara^T gene expression report.

 We are excited by the potential effect clara^T may have for future oncology biomarker discovery research.”

For further information on clara^T visit the almacgroup.com/diagnostics/claratreport  

About clara^T Report

The results displayed in the clara^T report are for research use only (RUO) and are not to be used for diagnostic or prognostic purposes, including predicting responsiveness to a particular therapy.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specialising in biomarker driven clinical trials. The company is focused on the discovery, development and commercialisation of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics.  

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group Launches claraT – A Unique, Software-driven Gene Expression Report appeared first on Almac.

The addition of the NovaSeq’s powerful processing capabilities to Almac’s existing range of NGS platform offerings allows for larger sample runs, greater read depth and faster speeds. The new instrument will ultimately reduce sample turnaround times and increase variant detection quality and accuracy for clients.

With the NovaSeq, Almac will be able to sequence the transcriptomes of up to ~384 samples, per run (dual flow cell, 50M reads per sample) in a timeframe as short as 36 hours.  The NovaSeq provides scalable throughput and flexibility for virtually any sequencing method, genome, and scale of project.  To accommodate NovaSeq’s high capacity and efficiency, Almac has also invested in appropriate informatics infrastructure and installed high speed uplinks to cloud based providers.

The NovaSeq will form an integral part of Almac’s current DNA and RNA Sequencing offerings and future offerings for Whole Genome Sequencing (WGS) and Whole Exome Sequencing (WES).  Almac Diagnostic Services already has extensive expertise in Next Generation Sequencing (NGS) technology and Bioinformatics. The company offers a customisable solution that allows clients to tailor their diagnostic requirements across multiple platforms and chemistry options to suit their specific translational research or clinical trial needs.

Michael Sloan, Global VP of Commercial Operations, Almac Diagnostic Services said: “We are excited about the potential benefits the NovaSeq will be able to bring to our customers with its sequencing capabilities enhancing our current DNA and RNA NGS panel offerings to the market. We are positioning ourselves at the cutting edge of NGS diagnostics and the investment in this new NGS platform will help Almac to continue to play a leading role within stratified medicine.”     

The NovaSeq will also support Almac Diagnostic Services new unique gene expression report, clara^T, which will be launched to market at ESMO 2018 in Munich in October. clara^T is a unique software-driven solution, classifying biologically relevant gene expression signatures into a comprehensive, easy-to-interpret report for cancer research / biomarker discovery.

For more information on Almac Diagnostic Services DNA and RNA NGS Panels offerings go to: https://www.almacgroup.com/diagnostics/clinical-trial-solutions/

For more information and to register an interest in Almac’s upcoming clara^T gene expression report:

https://www.almacgroup.com/diagnostics/clarat-total-mrna-report/

###

 About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specialising in biomarker driven clinical trials. The company is focused on the discovery, development and commercialisation of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics.

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group Invests in Cutting Edge Next Generation Sequencing Capabilities for Bio Pharma Clients appeared first on Almac.

As part of Almac’s ongoing growth strategy, this significant expansion adds a fourth building to the Durham campus and provides additional office space for more than 100 new employees over the next three years. This additional capacity complements Almac’s existing Durham facility which offers a range of end-to-end clinical trial supply solutions to clients globally, as well as Almac Diagnostic Services which provides biomarker driven clinical trial solutions.

Donna Christopher, Global Vice President of Operations, Almac Clinical Services, commented:

“Almac’s exceptional quality is demonstrated by our dedicated employees, all of whom work hard to strengthen relationships for long-term collaboration. We are delighted that this further investment in our Durham facilities enables us to continue to support our clients’ needs and meet the increased demands for our integrated services. This expansion not only provides us with a stronger ability to service our growing customer base but it also serves to demonstrate our commitment to being the most trusted and stable name in the clinical supply marketplace.”

This expansion of service capacity comes shortly after the conclusion of Almac’s previous $5.2 million investment at the North Carolina facility in 2016, which saw the expansion of its Clinical Services operations along with the development of its Diagnostic Services and Clinical Technologies services. In its fifth decade of operations – with over twenty of these in North America – Almac’s commitment to be the partner of choice providing an array of innovative clinical solutions worldwide continues with ongoing expansion plans in development.

###

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Invests to Expand its Existing North Carolina Facility appeared first on Almac.

 CLIA compliant assay, for clinical trial use, including US and Europe

Validation performance specifications for review on Almac Diagnostic Services’ website

Craigavon, N.I., Monday 16th April 2018 – Almac Diagnostic Services, a global stratified medicine company specialising in biomarker driven clinical trials, has analytically validated Illumina’s TruSight® Tumor 170 cancer mutation panel as an IUO assay for prospective testing in clinical trials.

Almac Diagnostic Services is now in a position to partner with interested Pharmaceutical and Biotech firms with the Almac clinical trial assay to support clinical trial enrichment for future cancer trials.

Almac Diagnostic Services was one of only a handful of labs globally to be granted beta test site status for the Illumina TruSight® Tumor 170 panel. This facilitated early access to the RUO version of the panel prior to Illumina’s initial commercial release back in 2016 and has allowed the labs at Almac to build up a vast amount of experience with the cancer panel over an extended period of time.

The Almac Illumina TruSight® Tumor 170 Clinical Trial Assay is a Next Generation Sequencing (NGS) assay for use with FFPE tissue from solid tumours that targets DNA and RNA variants from the same sample. The Almac assay covers common cancer genes including key actionable mutations across multiple cancers. It targets single nucleotide variants, indels and gene fusions. The clinical trial assay does not cover amplifications or splice variants, but these can be identified in the RUO version of the assay also offered by Almac Diagnostic Services.

Michael Sloan, Global VP of Commercial Development, Almac Diagnostic Services said: “This Almac Diagnostic Services clinical trial assay will provide Pharmaceutical and Biotech companies with a new option in the marketplace to support their clinical trials and CDx development. The assay, based on the Illumina TruSight Tumor 170 chemistry and NextSeq platform, allows multiple biomarkers to be evaluated from one sample, thereby reducing the quantity of precious tissue sample necessary and offering a highly cost effective solution that will ultimately be kit-able further downstream.

He continued: “It’s a strong tool in our repertoire of broad screening assays for our clients. This offering can enable them to assess both DNA and RNA on an appropriate broad range of genes. From the Pharma or Biotech perspective, they’re going to have a drug, or a panel of drugs, for which they want to select a relevant biomarker to enable personalised treatment. So it’s an optimal screening mechanism for them.”

Almac Diagnostic Services offers clients powerful reporting for the assay through their own bioinformatics pipeline and software solution providing enhanced variant call reproducibility, accuracy and QC. Should clients also need further RUO interpretation of detected variants, Almac can also offer ‘IBM Watson for Genomics’ reporting for processed samples.

For more information on the Almac TruSight® Tumor 170 clinical trial assay and to view the validation performance specification visit the Almac Diagnostic Services website:

https://www.almacgroup.com/diagnostics/trusighttumor170/

ENDS

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specialising in biomarker driven clinical trials. The company is focused on the discovery, development and commercialisation of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

For more information visit: almacgroup.com/diagnostics  

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Diagnostic Services Validates Illumina TruSight® Tumor 170 Cancer Mutation Panel for Prospective Testing in Clinical Trials appeared first on Almac.

The DNAnexus cloud-based CTS enables the use of genomic and other -omic information in combination with trials data, to reduce the time and cost of clinical development, and improve trial results and patient care.

Almac Diagnostic Services has expertise in the development of biomarker assays for commercial partners across a wide range of technologies and has an extensive track-record in validating assays across key regulatory standards, including; CLIA, CLEP, CE-IVD and FDA.

“Genomic-based clinical trials are critical in identifying patient populations most likely to benefit from a targeted treatment,” said Dr Timothy Davison, VP of Data Sciences & Biostatistics, Almac Diagnostic Services. “The process of developing and validating a biomarker into a test fit for clinical delivery is complex. DNAnexus offers the industry’s most comprehensive security and privacy framework, which provides our global labs auditability, data immutability, and scalability to implement a streamlined integration of genome-based biomarker delivery in clinical trials.”

“The use of next-generation sequencing in clinical trials is on the rise, and we anticipate that the FDA will embrace these new clinical trial methodologies,” said Richard Daly, CEO of DNAnexus. “DNAnexus believes that the incorporation of genomic data into clinical trials will lead to more targeted therapies and improved companion diagnostics. Almac Diagnostic Services is a global leader in precision medicine and we’re excited to collaborate on bringing genomic-based targeted medicines to patients more quickly.”

Bringing a single oncology drug through FDA approval can take over a decade and cost more than $1 billion. By investing in NGS sequencing in early-stage clinical development, later phases can be optimized and de-risked through biomarker-driven participant selection and intervention guidance. The DNAnexus CTS combines secondary analysis, interpretation, and translational informatics solutions, on a GxP-compliant, quality managed, audit-friendly, cloud-based Platform-as-a-Service. The same compliant DNAnexus service powers the FDA’s precision FDA platform for advancing regulatory standards for NGS-based drugs and devices.

“Pharmaceutical companies and their research partners are looking for ways to incorporate human genome and microbiome-based insights into their clinical trial designs, and have been frustrated with the cost and time to deploy and operate GxP-compliant systems to manage high-throughput genomics data,” continued Richard Daly. “The DNAnexus Clinical Trial Solution enables our customers to rapidly integrate genomics into adaptive trial design and significantly improve outcomes, ensuring consistency and reproducibility of results across geographical regions and research partners.”

Deploying, qualifying, and validating bioinformatic tools for genomic data analysis, and operating GxP-compliant services, are specialized tasks that are required for discovery and use of genomics-based insights in clinical trials. The DNAnexus CTS enables biopharmaceutical companies to transition validated NGS pipelines from translational research into clinical development and, for approved drugs and devices, into clinical and companion diagnostics, all in compliance with HIPAA, CAP/CLIA, and GxP regulations.

For more information about Clinical Solutions and the DNAnexus Platform, please visit dnanexus.com/clinicaltrials

ENDS

About DNAnexus
DNAnexus, the global leader in biomedical informatics and data management, has created the global network for genomics and other biomedical data, operating in North America, Europe, Asia-Pacific (including China), South America, and Africa. The secure, scalable, and collaborative DNAnexus Platform helps thousands of researchers across a spectrum of industries – biopharmaceutical, bioagricultural, sequencing services, clinical diagnostics, government, and research consortia – accelerate their genomics programs globally. For more information on DNAnexus, please visit www.dnanexus.com or follow the company @DNAnexus.

About Almac Diagnostic Services
Almac Diagnostic Services is a global precision medicine company focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. We partner with biopharma companies to provide solutions ranging from pre-clinical biomarker discovery to companion diagnostic development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited lab. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials. For more information visit: almacgroup.com/diagnostics

About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo). To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Diagnostic Services Partners with DNAnexus to Power Clinical Trial Assay Development appeared first on Almac.

Whether a prostate cancer patient has a slow-growing or aggressive tumour will affect the type of treatment required. It is only through understanding the type and genetics of the particular cancer tumour that clinicians will be able to put an effective treatment plan in place.

Lead researcher, Dr Suneil Jain from the Centre for Cancer Research & Cell Biology at Queen’s University Belfast explains: “Current diagnosis of prostate cancer involves biopsies, scans and blood tests to determine how aggressive the cancer is and subsequently to develop an appropriate treatment plan. Doctors repeatedly report that these tools aren’t always effective in determining how aggressive the cancer is, which can mean it is difficult to decide on the best treatment for an individual patient.”

Global Personalised medicine company Almac Diagnostic Services has developed a gene expression biomarker, known as Metastatic Assay, which aims to identify prostate cancer patients with aggressive disease. The test analyses the genetics of the tumour enabling clinicians to understand the type of tumour, whether it is a slow-growing or aggressive and if the latter, to what extent.

Researchers at Queen’s University Belfast led the world’s largest study of this kind, using Metastatic Assay on prostate biopsies from 248 patients who had previously been treated for prostate cancer. The research findings, published in Annals of Oncology, found the diagnostic test to be more effective than the standard clinical tests.

Professor Richard Kennedy, Global VP and Medical Director at Almac Diagnostic Services and McClay Professor in Medical Oncology at Queen’s University Belfast commented: “The assay has now proven to be superior to conventional clinical tests at predicting aggressive disease in two independent studies, the first of which used surgical tissue, while this study used tissue taken from needle biopsy. We believe it will play an important role in identifying men who may benefit from treatment intensification.”

Treatment options available to prostate cancer patients include radiotherapy, chemotherapy, brachytherapy and hormone therapy. Although radiotherapy is often used to effectively treat patients with prostate cancer, 20- 30% of patients can relapse within five years. Dr Jain explains: “The relapse of many prostate patients could be avoided through undergoing more intensive treatment including higher dosages of radiotherapy. There are also potential side-effects associated with administering more intensive treatment so a test that enables us to deliver the right treatment to the right patient would be extremely beneficial in clinical practice.”

The project was funded by Prostate Cancer UK and the Movember Centre of Excellence, a joint venture between Queen’s University Belfast and academic colleagues in Manchester.

Dr Iain Frame, Director of Research at Prostate Cancer UK said: “This research could provide clinicians with the answers they need to identify which cancers are likely to spread and give men peace of mind that the decision they make regarding their treatment is the right one. It’s still early days but it’s great to see how the work taking place at the Movember Centres of Excellence has the potential to bring about real change for men. We look forward to further results.”

Notes to Editor

 1. About Almac Diagnostic Services

Almac Diagnostic Services is a global personalised medicine company focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. Our approach to personalised medicine is poised to change the way that medicines are developed, regulated and prescribed. We partner with biopharma companies to provide solutions ranging from pre-clinical biomarker discovery to companion diagnostic development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited lab. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

An emphasis on scientific and technological excellence combined with a committed and passionate multi-functional team, puts Almac Diagnostic Services in a leadership position to take companion and other diagnostic tests all the way through development and to commercialisation.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs in 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

almacgroup.com

2. The Movember Centre of Excellence is based within the Centre for Cancer Research and Cell Biology (CCRCB) at Queen’s University Belfast. The Movember Centre of Excellence was launched in 2014 in partnership with Prostate Cancer UK. The Belfast-Manchester centre specifically aims to improve outcomes for men living with advanced disease.

For further information visit: prostatecanceruk.org/research/

The post Queen’s University Belfast in Collaboration with Almac Group Lead Largest Study of its Kind to Transform Prostate Cancer Treatment appeared first on Almac.

Almac’s molecular assay detects a subgroup of patients with a defective FA/BRCA pathway, who are more susceptible to DNA damage and therefore likely beneficiaries of DNA-damage therapeutic agents such as anthracyclines and PARP inhibitors. Furthermore, DNA damage leads to the activation of a specific innate immune response pathway (cGAS/STING/TBK1/IRF3) and activation of immune checkpoint targets (such as PDL1 and IDO1), hence confirming the assay may be used to predict response to immune checkpoint inhibitors. Almac documented these findings in a study entitled “Activation of STING-Dependent Innate Immune Signalling By S-Phase-Specific DNA Damage in Breast Cancer” published by the Journal of National Cancer Institute (JNCI) last year.

“Almac has been at the forefront of RNA based genomic innovation for over 10 years and this patent is expected to be the first of many in the US and EU to protect our innovative pipeline of predictive tests,” said Professor Paul Harkin, President and Managing Director, Almac Diagnostic Services. “The biology behind the DDRD assay is now well established with the first clinical validation for predicting response to DNA damaging agents in breast cancer published in JNCI back in 2014. Further validation is planned to ensure all applications are made commercially available and the significant benefits are realised by patients in the near future.”

About Almac Diagnostic Services

Almac Diagnostic Services is a global personalised medicine company focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. Our approach to personalised medicine is poised to change the way that medicines are developed, regulated and prescribed. We partner with biopharma companies to provide solutions ranging from pre-clinical biomarker discovery to companion diagnostic development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited lab. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

An emphasis on scientific and technological excellence combined with a committed and passionate multi-functional team, puts Almac Diagnostic Services in a leadership position to take companion and other diagnostic tests all the way through development and to commercialisation.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown almost 50 years and now employs in excess of 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

almacgroup.com

The post Almac Group Awarded U.S. Patents for Ground-breaking “DDRD” Assay appeared first on Almac.

Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostic Services and McClay Professor in Medical Oncology, Queen’s University Belfast commented “An unbiased discovery approach was used to identify a molecular subtype of primary prostate cancer that demonstrated metastatic biology.  This approach has created a very robust assay with excellent performance, independent of clinical factors such as Gleason and CAPRA. We believe it will play a significant role in aiding clinicians to select the most appropriate therapy regimen for their patients.”

The study was conducted in conjunction with The Movember / Prostate Cancer UK funded Prostate Cancer Centre of Excellence at Queen’s University of Belfast and Manchester University along with Cardiff University, University College Dublin, Oslo University and the University of Surrey. Independent assay validation was performed using 322 radical prostatectomy samples with Metastatic Assay positive patients having increased risk of biochemical recurrence (Multivariable HR 1.62; p= 0.0092) and metastatic recurrence (Multivariable HR=3.20; p=0.0001). A combined model with CAPRA-S identified patients at increased risk of biochemical and metastatic recurrence superior to either model alone (HR=2.67; p<0.0001 and HR=7.53; p<0.0001) respectively.

“The publication of this manuscript in a journal of this calibre represents a significant milestone in the assay’s development and with two additional manuscripts being prepared for submission, further milestones are expected to be reached later this year.  The first is another clinical validation but this time using biopsy FFPE tissue and the second is analytical validation to demonstrate the assay can be transferred to several commercial platforms.” said Professor Paul Harkin, President and Managing Director, Almac Diagnostic Services. He went on to say “Almac has been at the forefront of RNA based genomic innovation for over 10 years and this assay represents just one of our innovative pipeline of predictive and prognostic tests”.

About Almac Diagnostic Services

Almac Diagnostic Services is a global personalised medicine company focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. Our approach to personalised medicine is poised to change the way that medicines are developed, regulated and prescribed. We partner with biopharma companies to provide solutions ranging from pre-clinical biomarker discovery to companion diagnostic development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited lab. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

An emphasis on scientific and technological excellence combined with a committed and passionate multi-functional team, puts Almac Diagnostic Services in a leadership position to take companion and other diagnostic tests all the way through development and to commercialisation.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown almost 50 years and now employs in 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Announces Publication of Prostate Cancer Metastatic Assay Validation appeared first on Almac.

Craigavon, N.I., 08 March 2017 – Almac Diagnostic Services, the global personalised medicine company, focusing on the discovery, development and commercialisation of complex diagnostic and companion diagnostic tests, has announced that it has been selected by the European Organisation for the Research and Treatment of Cancer (EORTC) as its preferred partner for molecular profiling of cancer patient samples collected by EORTC clinical trials, including SPECTA (Screening Patients for Effective Clinical Trial Access), a pan-European Cancer network.

The ambition of EORTC is to streamline patient inclusion in clinical trials of molecularly targeted treatment, gaining efficiency from reliable centralised molecular testing. In addition, EORTC seeks to standardise Next Generation Sequencing (NGS) and Gene Expression Analysis in translational research projects, enhancing reproducibility and comparability of results.

Almac Diagnostic Services will receive and process patient samples across multiple disease types from various locations across Europe, using the new Illumina Trusight Tumor 170 solid tumor NGS panel to analyse patterns of genomic variation within patient samples. The company will provide this service from its European facility in Craigavon, Northern Ireland.

The output of the analysis by Almac Diagnostic Services will contribute to the SPECTA database, which will be an invaluable resource to the Oncology community in terms of therapeutic development and identification of novel biomarkers of response and prognosis as well as diagnosis of cancer patients. This will ultimately lead to the development and commercialisation of future companion diagnostics.

Michael Sloan, VP of Commercial Operations at Almac Diagnostic Services said: “The SPECTA Programme is a unique cancer research initiative enabling personalised medicine through its key collaborations across Europe. We are proud to have been chosen by the EORTC as a partner of choice for the molecular profiling of these valuable SPECTA samples and excited by the opportunities the generation of this data will provide to improve patient care.”

Vassilis Golfinopoulos, EORTC Medical Director said: “This agreement with Almac Diagnostic Services is one of several key partnerships EORTC has established to further develop the SPECTA infrastructure. Through the Illumina Trusight Tumor 170 solid tumor NGS panel and pipeline, EORTC seeks to improve substantially all stages of therapeutic agents development, from early clinical assessment to refinement of targeted molecular indications.”

John Leite, PhD, Vice President of Oncology at Illumina said: “Illumina believes that TruSight Tumor 170 can become the standard across the industry for how cancer-relevant genetic variants are identified and, through the research done by SPECTA, lead to new diagnostics that will guide precision oncology decisions. The next step in this realization is to provide efficient access for patients to molecularly driven clinical trials. This is the goal of the collaboration between Almac Diagnostic Services and the EORTC, which Illumina fully supports.”

~ENDS~

Notes for Editors:

For more information e-mail media@almacgroup.com.

About Almac Diagnostic Services

Almac Diagnostic Services is a global personalised medicine company focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. Our approach to personalised medicine is poised to change the way that medicines are developed, regulated and prescribed. We partner with biopharma companies to provide solutions ranging from pre-clinical biomarker discovery to companion diagnostic development including regulatory submissions and commercialisation. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited lab. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilised in phase I to phase III registrational clinical trials.

An emphasis on scientific and technological excellence combined with a committed and passionate multi-functional team, puts Almac Diagnostic Services in a leadership position to take companion and other diagnostic tests all the way through development and to commercialisation.

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel.  Almac is headquartered in Craigavon, Northern Ireland with operations in Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

About EORTC

The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 4,800 collaborators from all disciplines involved in cancer treatment and research in more than 800 hospitals in over 41 countries. A unique pan-European clinical research infrastructure, EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices through translational and clinical research.

More information: www.eortc.org

The post Almac Diagnostic Services and EORTC Establish Collaboration for Tumour Molecular Profiling appeared first on Almac.

Almac Diagnostic Services, the global personalised medicine company, focusing on the discovery, development and commercialisation of complex diagnostic and companion diagnostic tests, has announced the appointment of Dr. Leeona Galligan (PhD, FRCPath) to the position of Vice President, UK Operations.

In her new role, Dr Galligan will be responsible for all UK based operations including commercial biomarker discovery, CLIA/FDA compliant analytical validation, downstream clinical testing, manufacturing and shipping of clinical specimen and release of controls and reagents for registrational clinical trials. In addition, she will continue to serve as a valuable member of the Almac Diagnostic Services’ Executive team helping to define and implement its global business strategy.

Leeona joined Almac Diagnostic Services in September 2009 as a Senior Scientist within its research and development department. In 2012, she was appointed Manager of the newly formed clinical testing laboratory and, in 2014, was subsequently promoted to Head of UK laboratory based Operations.

Leeona obtained a B.Sc (Hons) in Genetics and a M.Med.Sc. (Laboratory Science) from Queen’s University Belfast and received her PhD in molecular haematology from Trinity College Dublin in 2003. Her research focused on the isolation and characterisation of a novel cellular receptor that is targeted in the treatment of sepsis. She subsequently completed a postdoctoral fellowship on the molecular mechanisms of drug resistance in colorectal cancer at the Department of Oncology at Queen’s University Belfast.

Following her Postdoctoral Fellowship, Leeona completed a 4 year training programme in specialist haemato-oncology laboratory services leading to her registration with the UK Health and Care Professions Council as a Clinical Scientist. She has also been awarded Fellowship of the Royal College of Pathologists (FRCPath) through examination in haemato-oncology and laboratory management.

“Leeona’s appointment to VP UK Operations is in recognition of the significant contribution she has made to our business over the past eight years,” said Paul Harkin, Managing Director & President, Almac Diagnostic Services.

“Her wealth of experience and expertise in the personalised medicine arena is a valuable asset which will help strengthen and deepen our Management team.  We look forward to working together to further develop our strategy and continue to offer our global clients an expanded array of services.”

Ends

Notes to editors

About Almac Diagnostic Services

Almac Diagnostic Services is a global personalised medicine company, focusing on the discovery, development and commercialisation of complex diagnostic and companion diagnostic tests.

Our global, state of the art, CLIA-accredited labs in the USA and Europe are ready to operate both research-use-only and clinical diagnostic assays. Our flexible approach allows Almac Diagnostic Services to be platform agile and to provide genuinely novel Diagnostic and CDx solutions for even the most challenging of Pharma and BioTech clients.

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel.  Almac is headquartered in Craigavon, Northern Ireland with operations in Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Diagnostic Services Appoints Dr Leeona Galligan as Vice President UK Operations appeared first on Almac.

Craigavon, N.I., 10 October 2016 – Almac Group’s Diagnostic Services business unit today announced the identification of a novel immune response mechanism in breast tumours deficient in DNA repair. The study has been published in the Journal of the National Cancer Institute (JNCI).

The publication entitled ‘Activation of STING-Dependent Innate Immune Signalling By S-Phase-Specific DNA Damage in Breast Cancer’ follows on from Almac’s previous publication of a 44 gene immune based assay capable of prospectively identifying breast cancer patients with a defect in the FA/BRCA pathway who benefit from anthracycline based chemotherapy.

The current study explains the molecular basis of this 44-gene immune based assay and demonstrates that the genes in the assay reflect activation of the innate immune response cGAS/STING/TBK1/IRF3 pathway in response to DNA damage.

The study is particularly interesting because it provides a clear rationale for the observed link between DNA repair deficiency and activation of the immune checkpoint PD-L1. Almac will now pursue their 44-gene assay as a means of prospectively identifying breast cancer patients likely to respond to PD-L1 targeted therapies.

The study was performed in collaboration with Queens University Belfast. Dr Eileen Parkes, Academic Clinical Lecturer at the Centre for Cancer Research and Cell Biology at Queen’s University said: “This research provides a new way of explaining how immune cells are targeted to certain breast tumours, and could help decide which patients are most likely to respond to this new class of immune therapies. Approximately one third of breast cancers will have this immune-rich picture, therefore a huge amount of patients could benefit from this research.”

Professor Richard Kennedy, MD, PhD, McClay Professor in Medical Oncology, Queens University Belfast and VP and Medical Director, Almac Diagnostic Services commented “The study provides strong justification for the underlying biology that causes enhanced PD-L1 expression. Almac will now engage with pharma and academia to investigate the potential clinical benefit for predicting response to immune checkpoint inhibitors, such as PD-L1 and IDO1 and their use in combination with DNA damaging agents”.

About Almac Diagnostic Services

Almac Diagnostic Services is one of five business units operating under the ownership of the Almac Group.  The global personalised medicine company is focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics.  In addition, Almac Diagnostic Services has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com/diagnostics/

The post Almac Group Discover an Exciting Link between its Immune Response Assay and Checkpoint Inhibitor Based Therapy appeared first on Almac.

Craigavon, N.I., UK & Boulder, CO – 04 October 2016 Almac Group’s Diagnostic Services business unit today announced its partnership with ArcherDx to provide FusionPlex® and VariantPlex NGS assays as part of their CDx partnership solutions.

ArcherDX, the leader in NGS-based fusion detection assays and software, has also approved Almac Diagnostic Services as a Certified Service Provider (CSP) of Archer® NGS assays. This agreement further establishes Almac Diagnostic Services as a trusted partner providing scientific and technological excellence globally.

Almac Diagnostic Services, the personalised medicine business unit of the Almac Group partners with Biopharma on the discovery, development and commercialisation of diagnostic tests including companion diagnostics.  It also has an internal portfolio of both prognostic and predictive assays in development across a wide range of disease areas.

As an Archer Certified Service Provider, Almac Diagnostic Services will leverage their CLIA-certified lab to include Archer FusionPlex® and VariantPlex™ assays in their service offering. About becoming an Archer CSP, Michael Sloan, VP Commercial Operations at Almac Diagnostic Services, stated, “Archer assays will not only enable us to offer targeted sequencing panels across a wide range of malignancies, but they give us the ability to customise gene panels based on our partners’ needs.”

Jason Myers, PhD, CEO at ArcherDX, added “Almac Diagnostic Services has a strong support network as part of the Almac Group, which gives them the ability to provide clinical services beyond the UK. Because clinical development is a global need, we’re excited that Almac Diagnostic Services can offer ArcherDX NGS assays for international drug and CDx development and clinical support.”

About ArcherDX

ArcherDX addresses the bottlenecks associated with using NGS in translational research by offering a robust platform for targeted sequencing applications.

By combining proprietary Anchored Multiplexed PCR (AMP™) chemistry and easy-to-use, lyophilized reagents, Archer NGS assays generate highly enriched sequencing libraries to detect gene fusions, point mutations, CNVs and RNA abundance. Complemented by the Archer suite of bioinformatics software, ArcherDX technology dramatically enhances complex mutation identification and discovery.

ArcherDX is headquartered in Boulder, Colorado, USA.

http://archerdx.com

About Almac Diagnostic Services

Almac Diagnostic Services is one of five business units operating under the ownership of the Almac Group.  The global personalised medicine company is focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics.  In addition, Almac Diagnostic Services has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com/diagnostics/

The post Almac Diagnostic Services Partner with ArcherDX appeared first on Almac.

The publication entitled ‘Association Between Results of a Gene Expression Signature Assay and Recurrence-Free Interval in Patients With Stage II Colon Cancer in Cancer and Leukemia Group B 9581 (Alliance)’ demonstrates that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer therefore indicating it’s potential utility with the traditional clinical markers of risk to refine patient prognosis.

The study was performed in conjunction with the Alliance for Clinical Trials in Oncology (Alliance) comprised of investigators from renowned institutions such as Duke University, Dana-Farber Cancer Institute, University of Chicago, Brigham and Women’s Hospital and Queen’s University Belfast.

This large, independent clinical validation study utilised data and samples from 393 stage II colon cancer patients enrolled in the phase III CALGB (Alliance) 9581 clinical trial to assess the ability of the prognostic, 634-probe gene expression signature (ColDx) to improve upon current methods of differentiating patients as higher versus lower risk of recurrence within five years post-surgery.  The signature remained significant after adjustment for conventional prognostic risk factors (hazard ratio = 2.13; 95% CI, 1.3-3.5; p < 0.01), including micro-satellite instability (MSI), T-stage and number of nodes examined.

Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostic Services and McClay Professor in Medical Oncology, Queen’s University Belfast commented “These findings confirm our previous independent validation results which were also published in the Journal of Clinical Oncology in 2011 and further substantiates the ColDx assay as an effective prognostic biomarker for stage II colon cancer. The ability to accurately stratify stage II colon cancer patients into low and high risk categories provides invaluable information, ensuring clinicians are better informed when deciding the most appropriate treatment for their patients.”

The ColDx assay has been out-licensed and is currently being marketed by Helomics® Corporation under the name GeneFx® Colon in the United States.

About Almac Diagnostic Services

Almac Diagnostic Services is one of five business units operating under the ownership of the Almac Group.  The global personalised medicine company is focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics.  In addition, Almac Diagnostic Services has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit almacgroup.com or e-mail media@almacgroup.com

About Helomics® Corporation

Helomics® is a comprehensive personalized healthcare company, bringing the next generation of diagnostics to the oncology field. Helomics is dedicated to improving patient outcomes by providing a comprehensive personalized tumor profile utilizing a proprietary set of laboratory platforms that leverage both live and fixed cellular analysis to allow physicians to personally characterize malignant tumors. Helomics’ novel molecular and cellular markers and bioinformatics services are designed to support treatment decisions by providing vital information based on the specific biological processes of each individual’s cancer.

Helomics is headquartered in Pittsburgh, Pennsylvania where the company maintains two CLIA-certified laboratories.  For more information please visit: www.helomics.com.

About GeneFx® Colon

GeneFx® Colon is a microarray-based gene signature developed for FFPE tissue from stage II colon cancer patients. GeneFx® Colon is performed on a small amount of tissue, removed during surgery and identifies patients at higher risk of recurrence within 5 years following initial surgery.  GeneFx® Colon is expected to provide better-informed and more personalised treatment decisions for the physicians and patients facing this disease.

The post Almac Publish Second Validation of Stage II Colon Cancer Recurrence Assay in the Journal of Clinical Oncology appeared first on Almac.

Almac Diagnostic Services is a personalised medicine company focused on the discovery, development and commercialisation of diagnostic and companion diagnostics tests. Almac’s global CLIA-accredited high-tech laboratories based in Craigavon, UK and Durham NC, USA are ready to operate both research-use-only and clinical diagnostic assays from a range of platforms including microarray, qPCR, NGS and IHC. Almac’s recent investment in NanoString’s novel digital molecular barcoding technology further supports our commitment to CDx partnerships, providing an additional platform choice on which to validate discoveries and translate them into clinically useful diagnostic assays.

NanoString’s nCounter Dx Analysis System with FLEX is a flexible platform used to translate oncology signatures from research to the clinic. The system supports research and development of clinical applications from basic discovery to the development of future molecular diagnostic tests on a single platform. Providing simple, multiplexed digital profiling of single molecules, the NanoString platform represents a natural, digital downstream companion to next-generation sequencing.

The nCounter system is uniquely positioned to support translational research on account of its ability to generate high-quality data from the difficult sample type’s common in clinical research, including Formalin-Fixed Paraffin-Embedded (FFPE) tissues.

NanoString’s new barcoding chemistry for the nCounter platform is a triple play, offering the ability to detect DNA, RNA, and proteins from the same sample and to harmonize the data analysis.

Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services commented: “Almac offers significant expertise in the discovery, development and delivery of multiplex RNA, DNA and protein based tests and currently partners with a number of major biopharmaceutical companies to assist with companion diagnostic development. Almac’s investment in the NanoString nCounter systems serve to provide an additional platform for the delivery of complex assays expanding the options available to Almac partners.”

Find out more:

The post Almac Diagnostic Services Expand Companion Diagnostic Development Service Offering with NanoString Barcoding Technology appeared first on Almac.

Along with headquarters in Europe and partnerships in Asia, the new facility in the US will provide Almac Diagnostic Services with a strong global presence to continue to meet increasing customer demand and to support their growing client base.

The custom designed facility is located amongst one of the most prominent high-tech research and development centres in the world and contains molecular biology laboratories as well as office space. The state of the art laboratory is equipped with microarray and qPCR platforms appropriate for companion diagnostic development and will operate both research-use-only and clinical diagnostic tests. Plans are also in place to add additional technology platforms including NGS in the coming year.

‘The opening of our new CDx facility in the US is Almac Diagnostic Services’ latest initiative to better serve our global Biopharma partners. As we experience increased client demand for our companion diagnostic development services, this latest expansion will significantly enhance Almac’s offering, increasing capacity and further demonstrating our commitment to personalised healthcare’ said Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

Almac Diagnostic Services is one of six business units operating under the ownership of the Almac Group.  The global company partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics. In addition, Almac Diagnostic Services has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

For more information visit almacgroup.com or e-mail media@almacgroup.com.

The post Almac Group Opens Additional Companion Diagnostic Laboratory in Durham NC USA appeared first on Almac.

The collaboration enables Almac to develop next-generation sequencing (NGS) assays using the Illumina MiSeqDx® instrument, the first FDA-cleared IVD NGS system designed specifically for the clinical laboratory environment.

Almac offers significant expertise in the development and delivery of multiplex RNA and DNA based tests and currently partners with a number of major biopharmaceutical companies to assist with companion diagnostic development. The collaboration with Illumina serves to provide an additional platform for delivery of complex assays expanding the options available to Almac partners.

‘We are extremely pleased to announce this collaboration with Illumina. We are fully committed to the development of precision medicine and partnerships of this nature provide more avenues for test delivery, enabling development of diagnostic tests which will ultimately improve care in a wide range of disease areas,’ said Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

Almac Diagnostic Services is one of six business units operating under the ownership of the Almac Group.  The global company partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics. In addition, Almac Diagnostic Services has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

For more information visit almacgroup.com or e-mail diagnostics@almacgroup.com.

The post Almac Group to Collaborate with Illumina on Next-Generation Sequencing Based Companion Diagnostic Development appeared first on Almac.

About OncoMed

The post Almac Group Announce Companion Diagnostic Partnerships with OncoMed appeared first on Almac.

Dr. Ford is a renowned scientific executive with extensive experience in the global pharmaceutical industry having held senior oncology biomarker focused posts in BMS, Roche and Novartis. Until recently, Dr. Ford was the Global Head of Correlative Sciences in Oncology Global Development at Novartis Oncology. She led a group that is focused on developing Oncology Biomarkers and supporting translational research activities for Oncology full development programs. Prior to this Dr. Ford was a Senior Biomarker & Experimental Medicine Leader at Roche Pharma Research & Early Development. Previously she was the Director of Clinical Biomarkers Oncology at Bristol-Myers Squibb where she led a group responsible for the discovery, validation and strategic implementation of pharmacodynamic and predictive markers for the late stage oncology portfolio (Phase I/II through Life Cycle Management).

Her key accomplishments include being the lead researcher on the team that discovered that EGFR ligand gene expression and K-ras mutation status are predictive markers of benefit from cetuximab (anti-EGFR monoclonal antibody therapy) in metastatic colorectal cancer. This work was published in a seminal publication in the Journal of Clinical Oncology and has been validated by her team and others in multiple large retrospective studies.  The biomarker research from her group has led to additional publications in journals such as the New England Journal of Medicine, multiple presentations at major international oncology conferences including ASCO, AACR and ESMO meetings and numerous patent applications.  As the Biomarker Lead for cetuximab, Dr. Ford was a key participant in regulatory and diagnostic activities in addition to providing scientific leadership and expertise.

“We are delighted to welcome Shirin Ford to the Almac team. We have brought her on board to take over the management of our internal product pipeline. Many of these products are now close to commercialization and her unparalleled experience in the industry will be invaluable as we drive forward these products.” said Professor Paul Harkin, President of Almac’s Diagnostic business unit.

The post Almac Group Appoints Dr. Shirin Khambata Ford as VP Product Development appeared first on Almac.

Stewart will be responsible for regulatory compliance of both client and internal companion diagnostic tests and maintaining quality systems to support these developments. He will also lead the regulatory strategy for Almac’s internal product pipeline.

The move is a promotion for Stewart who has been employed at Almac for over a decade and has gained considerable regulatory experience working at the most senior level with clients to support their Companion Diagnostics regulatory strategies with the FDA, EMA and more recently CFDA.

Professor Paul Harkin, MD Almac’s Diagnostic Services business unit commented “Stewart’s wealth of experience and expertise has been invaluable to our team and this promotion was the natural next step. This new appointment enables us to further develop and successfully drive our strategy for planned future expansion into new markets and we look forward to Stewart’s contribution to our continued growth”.

The post Almac Appoints VP Quality and Regulatory Affairs appeared first on Almac.

The study performed by Precision Therapeutics in conjunction with the Alliance for Clinical Trials in Oncology (Alliance) comprised of investigators from renowned institutions such as Duke University, Dana-Farber Cancer Institute, University of Chicago, Brigham and Women’s Hospital, among others, demonstrates that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer. Findings were presented at the 2014 Gastrointestinal Cancers Symposium (ASCO-GI) held January 16-18^th, in San Francisco, California.

This large, independent clinical validation study utilised data and samples from 393 stage II colon cancer patients enrolled in the phase III CALGB (Alliance) 9581 clinical trial to assess the ability of the prognostic, 634-probe gene expression signature (ColDx) to improve upon current methods of differentiating patients as higher versus lower risk of recurrence within five years post-surgery.  The signature remained significant after adjustment for conventional prognostic risk factors (hazard ratio = 2.1; 95% CI, 1.3-3.4; p < 0.01), including micro-satellite instability (MSI), T-stage and number of nodes examined. These findings confirm the previous independent validation results published in the Journal of Clinical Oncology in 2011 (Kennedy, et al.). The ColDx assay will be marketed by Precision Therapeutics, Inc. under the name GeneFx^® Colon in the United States.

“We are delighted that the ColDx assay has, once again, been validated as a prognostic biomarker for early stage colon cancer” says Richard Kennedy, MD, PhD, McClay Professor in Medical Oncology, Queens University Belfast and VP and Medical Director, Almac Diagnostic Services.  “We believe this assay has the potential to help clinicians personalise the treatment of this disease and look forward to its full commercial launch this year by Precision Therapeutics.”

About GeneFx^® Colon

GeneFx^® Colon is a microarray-based gene signature developed for FFPE tissue from stage II colon cancer patients. GeneFx^® Colon is performed on a small amount of tissue, removed during surgery and identifies patients at higher risk of recurrence within 5 years following initial surgery.  GeneFx^® Colon is expected to provide better-informed and more personalised treatment decisions for the physicians and patients facing this disease.

About The Alliance for Clinical Trials in Oncology

The Alliance for Clinical Trials in Oncology is a national clinical trials network sponsored by the National Cancer Institute that consists of a network of nearly 10,000 cancer specialists at hospitals, medical centers, and community sites across the country and Canada. The Alliance is dedicated to developing and conducting clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as researching methods to alleviate side effects of cancer and cancer treatments.

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel.  Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

Almac Diagnostic Services is a division of Almac Group Ltd focusing on the discovery, development and delivery of novel prognostic and predictive tests.

Almac Diagnostic Services has a pipeline of oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

In addition Almac Diagnostic Services partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics.

Visit almacgroup.com, e-mail info@almacgroup.com

About Precision Therapeutics

Precision Therapeutics, a leading life-science company based in Pittsburgh, Pennsylvania, is dedicated to personalising cancer care and improving patient outcomes.  Precision offers a portfolio of products developed to help guide physicians with difficult clinical decisions throughout the cancer care continuum.

In addition to GeneFx Colon, Precision’s leading personalised medicine products include:

• ChemoFx^®, a proprietary drug response marker which categorises an individual patient’s tumor response to a range of standard chemotherapeutic options.  Recently published data demonstrates a 14-month improvement in overall survival (OS) when recurrent ovarian cancer patients are treated with ‘responsive’ therapies as indicated by ChemoFx^®.
• BioSpeciFx^®, a portfolio of clinically relevant molecular tests that provide information about drug response and patient prognosis.
• Precision also offers the microRNA-based Rosetta Genomics Cancer Origin Test^®, which identifies 42 tumor origins with overall specificity up to 99% and overall sensitivity up to 85%.

The post Data Presented Supporting Almac Developed Colon Signature as a Significant Predictor of Risk of Recurrence in Stage II Colon Cancer appeared first on Almac.

The article entitled “Identification and Validation of an Anthracycline/Cyclophosphamide– Based Chemotherapy Response Assay in Breast Cancer” led by Almac’s Medical Director, Professor Richard Kennedy gives detail on the development and initial validation of a predictive gene signature for chemotherapy response in breast cancer.

Breast Cancer is the world’s most common cancer among women with one in eight diagnosed in their lifetime. Although modern chemotherapy reduces the risk of recurrence for some patients, not everyone benefits. At present there is no means of identifying those patients who will and will not respond to first line therapy. Almac’s objective in the development of this assay was to provide a means of identifying those breast cancer patients more likely to respond to standard of care chemotherapy treatment.

The assay was developed by Almac in collaboration with Queens University Belfast and the Mayo Clinic, Rochester, USA. Almac carried out microarray analysis of patient samples and identified a molecular subgroup with a deficiency in DNA damage repair, termed DDRD for DNA Damage Repair Deficient. Almac then developed a 44 gene classifier capable of prospectively identifying this molecular group in patient tumour samples.

The DDRD signature was then initially validated in a neo-adjuvant breast cancer cohort. In the neo-adjuvant setting the assay predicted complete pathologic response with an odds ratio of 3.96, meaning those patients that were DDRD positive were almost four times more likely to respond to treatment compared to patients that were DDRD negative. In the adjuvant setting, a DDRD positive result predicted 5 year relapse free survival with a Hazard Ratio 0.37 compared with test negative patients.

“The publication of this data represents a significant milestone for Almac as we transition this assay into the clinic. The publication of these results combined with our recent out-licensing of the assay to Genomic Health for use in breast cancer patients, highlights the quality of the science being carried out here in Almac” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business unit.

The test has been developed and validated exclusively using formalin fixed paraffin embedded (FFPE) tissue using Almac’s own proprietary Breast Cancer DSA®.

The post Almac publishes breast cancer chemotherapy response assay in the Journal of the National Cancer Institute appeared first on Almac.

REDWOOD CITY, Calif., and (CRAIGAVON, UK) Nov. 25, 2013 — Genomic Health, Inc. (Nasdaq: GHDX) and ALMAC GROUP Ltd jointly announced today that Genomic Health will exclusively license Almac Group’s technology and intellectual property to further develop, validate and subsequently commercialise a multi-gene test to predict benefit from DNA damage-based chemotherapy drugs, such as the commonly used anthracycline-based regimens, in breast cancer.  Such a test would be particularly useful for high-risk breast cancer patients who are eligible for chemotherapy based on their Oncotype DX® score.

Genomic Health will identify a study cohort for the validation of Almac’s previously identified and published genes.  Genomic Health made an up-front payment of $9 million dollars, which the company expects to expense in the fourth quarter of 2013, and will pay additional milestones as certain clinical and commercial endpoints are achieved in the future. Upon successful commercialisation of the test, Genomic Health will pay additional royalties to Almac Group.

“Working with Almac, we have the opportunity to gain further insight on the role of DNA repair in drug efficacy, which may provide clinical utility to help select which breast cancer patients benefit from specific chemotherapy drugs and regimens,” said Steven Shak, M.D., Executive Vice President of Research and Development of Genomic Health.  “Over the past ten years Oncotype DX has played a critical role in predicting benefit of chemotherapy, in general, for more than 400,000 estrogen-receptor positive breast cancer patients.  This new test may address another unmet need by providing additional information specific to the benefit from anthracycline-based regimens for high-risk patients and possibly those with triple negative breast cancer as well.”

Anthracycline-based chemotherapy regimens are commonly used to treat breast cancer, but have significant toxicities that can be debilitating and impact long-term quality of life.  Currently, the decision to use these therapies is based on conventional clinical and pathologic factors including age, tumor grade, tumor size and patient comorbidities.  However, none of these factors accurately determine which patients will benefit from anthracycline-containing regimens.

“As developers of novel prognostic and predictive tests, we are very pleased to partner with Genomic Health and look forward to leveraging their rigorous clinical validation approach and commercial expertise to advance our development work to reach patients,” said Paul Harkin, President and Managing Director of Almac Diagnostic Services. “We see tests such as this having a significant impact on accelerating personalised healthcare thereby improving the clinical management of cancer patients.”

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from screening and surveillance, through diagnosis, treatment selection and monitoring.  Genomic Health’s lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS).  In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of September 30, 2013, more than 19,000 physicians in over 70 countries had ordered nearly 400,000 Oncotype DX tests.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.

About Almac Group

 ‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel.  Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

Almac Diagnostic Services is a division of Almac Group Ltd focusing on the discovery, development and delivery of novel prognostic and predictive tests.

Almac Diagnostic Services has a pipeline of oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

In addition Almac Diagnostic Services partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics.

Visit almacgroup.com, e-mail info@almacgroup.com

Torreya Partners LLC advised Almac Group Ltd in this transaction

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our plans to develop and validate a test for prediction of benefit from DNA damage-based regimens including Anthracycline for High Risk Breast Cancer; the expectation that the initial study results of the Almac group will be confirmed in further studies; our plans to commercially launch an Oncotype DX test for DNA damage-based regimens including Anthracycline Benefit Assay for High Risk Breast Cancer; the potential indications for use of a test;  the ability of any such test to individualize cancer treatment decisions ; the potential of the test to change medical practice for high risk breast cancer patients ; the ability of the company to develop additional tests in the future; the scope, success or results of clinical trials and the timing of such activities; the ability to meet clinical and commercial endpoints; the timing and amount of any future milestone or royalty payments;  the applicability of clinical study results to actual outcomes; the ability of the company to obtain and maintain adequate reimbursement for the test; our beliefs regarding the attributes of our product pipeline; and our ability to develop additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, the results of clinical studies; the applicability of clinical study results to actual outcomes; the risks and potential delays associated with such studies; the risks, costs and potential delays associated with the commercialization of current and future products; unanticipated costs or delays in research and development efforts; risks and uncertainties associated with the regulation of and reimbursement for our tests, both domestically and abroad; our ability to compete against third parties; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September  30, 2013. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements. 

The post Genomic Health and Almac Group Enter Exclusive In-Licensing Agreement to Develop and Commercialize Anthracycline Chemotherapy Benefit Test for High Risk Breast Cancer appeared first on Almac.

Almac, a personalised medicine company with CAP accredited and CLIA certified laboratories, extends their portfolio of services by offering TruSight Tumor™ to complement its current range of RNA, DNA and protein based technologies for biomarker analysis.

Almac is currently running many bespoke diagnostic assays for pharma customers for early phase clinical trial enrichment.  The TruSight Tumor™ panel enables additional profiling of these patient samples to provide Almac’s pharma partners with further important information on emerging biomarkers that may also impact drug response.

The TruSight Tumor™ panel was developed by Illumina for their MiSeq® system, allowing targeted DNA sequencing and reporting on the mutation status of 26 genes which are most commonly mutated in solid tumors including lung, colon, ovarian, melanoma and gastric cancers.

One of Almac’s key strengths is many years of experience in working with formalin fixed paraffin embedded (FFPE) tissue. The TruSight Tumor™ panel is specifically designed for use with FFPE samples, and enables the highest levels of sensitivity for mutation detection with limited DNA input requirements.

“Almac is committed to the development of personalised medicine through the delivery of a wide range of innovative solutions. We are pleased to announce the expansion of our NGS service to include TruSight Tumor™” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic business unit.

Notes to Editors

About Almac

‘Partnering to Advance Human Health’

Almac’s Diagnostic Services business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel.  Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

The post Almac Offering TruSight Tumor Profiling Next-Generation Sequencing Service appeared first on Almac.

These latest enhancements to Almac’s service portfolio include a comprehensive range of NGS solutions from professional study design to sample processing and expert data analysis for DNA and RNA samples.  Uniquely, the services are highly customizable and are available on a standalone basis or in combination with Almac’s established bioinformatics offerings in the areas of biological analysis, biomarker and drug discovery and development and diagnostic product development.  Almac will utilize the latest sequencing technologies and most sophisticated modern computational analysis techniques to ensure optimal results from customer data.

The solutions are delivered through a large and experienced bioinformatics team from a wide range of disciplines including biology, medicine, mathematics and biostatistics. In addition to the team’s expertise in bioinformatics and biostatistics they also have substantial experience in molecular and cell biology, drug discovery and development, and diagnostic product development.

Michael Sloan, Vice President of Business Development for Almac said:

“NGS is a rapidly maturing technology that continues to demonstrate significant benefits over traditional methods as well as making substantial steps toward routine use in the clinical setting.  By expanding our services to include this range of DNA and RNA-Seq analysis we are empowering our customers with the most cutting edge technologies, opening new avenues within their research and boosting the potential for advancement of human health in a variety of disease settings”.

Almac’s NGS services build upon long standing expertise in the application of cutting edge technology to the improvement of human health.

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The post Almac announce launch of Next Generation Sequencing (NGS) Data Analysis Services appeared first on Almac.

The laboratory’s director, Richard Kennedy, MBChB, PhD, was advised of the national recognition and congratulated for the excellence of the service provided by Almac.

The CAP Laboratory Accreditation Program commenced in the early 1960s and is recognized by the federal government as being equal to or more stringent than the government’s own inspection program.

During the CAP accreditation process, inspectors examine the laboratory’s records and quality control of procedures for the preceding two years.  CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and the overall management of the lab.  This stringent inspection program is designed to specifically ensure the highest standard of care for all laboratory patients.

President and Managing Director, Professor Paul Harkin commented on the achievement “This accreditation allows us to further support our clients by running clinical diagnostic tests for trial enrichment. This is of increasing importance to our clients and constitutes an important part of our biomarker services”.

Notes to Editors:

About Almac:

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,300 individuals and is headquartered inCraigavon,Northern Ireland.US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

About the College of American Pathologists:

The College of American Pathologists (CAP), celebrating 50 years as the gold standard in laboratory accreditation, is a medical society that serves more than 17,000 physician members and the global laboratory community.  It is the world’s largest association composed exclusively of Board-certified pathologists and is the worldwide leader in laboratory quality assurance.  The College advocates accountable, high-quality, and cost-effective patient care.  More information about the College can be found at www.cap.org.

The post Almac’s Diagnostic Laboratory Receives Accreditation from College of American Pathologists appeared first on Almac.

The article entitled “Development and Independent Validation of a Prognostic Assay for Stage II Colon Cancer Using Formalin-Fixed Paraffin-Embedded Tissue” gives detail on the development and validation of a prognostic gene signature in Stage II colon cancer.

Colon Cancer is the third most common cancer in the United States with over 101,000 cases diagnosed per year.

Current clinical guidelines for patients presenting with stage II colon cancer recommend treatment with surgery alone. This is effective for around 80% of patients, however 20% of the patients will experience recurrence of the disease and for these patients there may be benefit in offering adjuvant chemotherapy. The Almac test will identify those patients that have higher risk of disease recurrence, providing valuable information to the Oncologist to support their further treatment decisions

Most prognostic factors routinely used in the clinic do not exceed a HR of 1.5. The Almac developed test gives a hazard ratio of 2.53 with a p-value of <0.001. The signature has also been shown to be independent of other prognostic factors.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic business unit and Professor of Molecular Oncology at Queens University Belfast said:

“The stage II ColDx test represents a significant breakthrough in colon cancer management. We believe that this test will change clinical practice and benefit cancer patients.”

The test has been developed and validated exclusively using formalin fixed paraffin embedded (FFPE) tissue using Almac’s own proprietary Colorectal Cancer DSA^®.

Professor Patrick Johnston, Dean, School of Medicine, Dentistry and Biomedical Sciences at Queen’s, said:

“We are pleased to have been able to play a role in helping Almac to develop this groundbreaking technology which we hope could save many lives in the future. Both Queen’s and Almac are working tirelessly in advancing cancer research and treatments.”

The signature is currently undergoing a final external validation study and will be available to patients in 2012.

 Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

The post Almac publishes Stage II colon cancer recurrence signature in the Journal of Clinical Oncology appeared first on Almac.

The research initiative, based at the Center for Cancer Research and Cell Biology (CCRCB) at Queen’s, will be led by Professor Richard Kennedy, one of Almac’s experts in personalised medicine – which tailors specific treatment to each cancer patient.

Invest Northern Ireland and The McClay Foundation, the charitable trust established by the late Sir Allen McClay, are partnering to fund the lab facilities and staff costs. Invest NI has offered the Almac Group and QUB £1.5 million of support towards the collaboration, which includes part funding from the European Regional Development Fund (ERDF).

The collaboration was announced ahead of CCRCB’s 3rd International Cancer Symposium tomorrow (Wednesday and Thursday 7-8 September), which attracts leading cancer experts from around the world to focus on how academia can interact with industry to improve cancer treatment.

Professor Kennedy, the newly appointed McClay Chair of Experimental Cancer Medicine at Queen’s University – a joint appointment with Almac – said the project was an excellent example of how business and academia could work together in the fight against cancer, the leading cause of death in Western civilizations.

He explained: “The research will involve using cutting-edge technology developed by Almac which will allow us to analyse large numbers of patient tumours collected by Queen’s.

“We will develop these tests to help clinicians to better understand prostate, ovarian and breast cancer and prescribe the appropriate treatments tailored to the specific patient.

“We hope this will then improve the chances of cure using chemotherapy and radiotherapy.

“Queen’s and Almac will also use this information to design new therapies that could improve the chances of response and cure for these cancers in the future.

“More effective treatments will be good news for patients and also for reducing the pressure on the overburdened healthcare system.”

Enterprise Minister Arlene Foster said: “Almac remains at the cutting edge of drug development and delivery for specific types of cancer and with Invest NI support, has invested heavily in research projects which have delivered significant economic benefits and advancements in cancer treatment worldwide.

“The company is globally respected for its commitment to innovation and this collaboration project will build upon a successful and longstanding research relationship between Almac and Queen’s University, Belfast. Such academic and industrial linkages are vital to the growth of our economy as they strengthen our knowledge base and enhance Northern Ireland’s reputation as an international research and development hub.”

At this week’s symposium Professor Kennedy will present new research on better tailoring chemotherapy for breast cancer. He will also introduce the speaker of the 2011 McClay Foundation Lecture, Richard M Goldberg from the University of North Carolina and North Carolina Cancer Hospital.

Notes to Editors

The Almac Group provides a broad range of pharmaceutical services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,000 and is headquartered in Craigavon, Northern Ireland. Its North American Headquarters are in Souderton, Pennsylvania and the company also has sites at North Carolina and California.

The McClay Foundation, established by Almac founder, the late Sir Allen McClay in 2008, is a charitable trust which aims to advance the use of diagnostic tools and drugs in the prevention, control and cure of the disease; support and encourage research and innovation in the field of healthcare and allied technologies increase capacity of all people and specifically those in the developing world to access the latest benefits in healthcare and to generate and promote employment opportunities for the people of Northern Ireland.

Invest NI has offered the Almac Group and QUB £1.5 million of support which includes part funding from the European Regional Development Fund under the Sustainable Competitiveness Programme for Northern Ireland.

For more information about Almac contact Jane Wells or Andrea Clements at JPR on 028 9076 0066. Jane.wells@jprni.com, 07860 288 860

Andrea.clements@jprni.com, 07808 761 857

The post Almac-Queen’s cancer expert to lead £4.4m collaboration appeared first on Almac.

Exonhit AclarusDx™ is a micro-array-based test intended to aid in the diagnosis of Alzheimer’s disease (AD) by detecting biomarkers specific for AD in peripheral blood. The test was CE marked in March 2011 and has now been introduced for clinical diagnostic use in France. The test will be performed by Almac from its ISO17025 accredited laboratory. Almac will deliver the AclarusDx™ result to the clinicians.

Almac recently announced the opening of its CLIA registered Clinical Testing laboratory from which it is currently delivering the Therascreen® K-RAS Mutation Test. AclarusDx™ will be the second commercial clinical test that will be managed by Almac. In addition to standard molecular tests Almac will deliver a range of novel, validated biomarker assays from its Clinical Testing Laboratory to facilitate the stratification and enrichment of prospective clinical trials.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business said:

“The partnership with Exonhit is an excellent arrangement for both companies. Exonhit will focus on the sales and marketing of AclarusDx while we will focus on the delivery of the diagnostic in our ISO17025 certified laboratory.”

Loïc Maurel, M.D., Chairman of the Management Board at Exonhit said:

“We chose Almac Diagnostic Services as our reference lab to perform the analytic phase of AclarusDx™ due to its strong expertise in molecular biology and its practice of the Affymetrix platform. We also view the location of Almac Diagnostic Services in Northern Ireland as an asset for the upcoming roll-out of AclarusDx™ in Europe.”

Ends….

Notes to Editors

About Almac

Almac’s Diagnostic Services business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.  Staff have now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About Exonhit

Exonhit (Alternext: ALEHT) is a biotech company, focused on personalized medicine, which develops targeted innovative therapeutic and diagnostic products, in oncology and Alzheimer’s disease. Exonhit has a balanced investment strategy with internal development programs and strategic collaborations, in particular with Allergan.

Exonhit is headquartered in Paris, France and has a U.S. subsidiary in Gaithersburg, Maryland. The Company is listed on Alternext of NYSE Euronext Paris and is part of the NYSE Alternext OSEO innovation index. For more information, please visit http://www.exonhit.com.

Disclaimer

This press release contains elements that are not historical facts including, without limitation, certain statements on future expectations and other forward-looking statements. Such statements are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those anticipated.

In addition, Exonhit, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications, and such statistical data and predictions are used in this press release for information purposes only.

Finally, this press release may be drafted in the French and English languages. In an event of differences between the texts, the French language version shall prevail.

The post Almac to perform the analytic phase of AclarusDx™ for Exonhit appeared first on Almac.

Two of Almac’s main research projects have been selected for presentation at the 2011 ASCO meeting. Both of these studies are based on Almac’s approach of profiling large clinical datasets and analysing the data for molecular subgroups that can aid in improved diagnosis of cancer by identifying molecular subtypes and by identifying molecular subgroups which are of clinical and therapeutic relevance.

The first study was carried out in ovarian cancer and will be the subject of a podium presentation by Dr Charlie Gourley of the University of Edinburgh Cancer Research UK Center, where the patients were treated. The aim of the study was to identify molecular subtypes of ovarian cancer through profiling of a large clinical dataset of 363 patient samples. Unsupervised analysis of the full dataset identified 6 molecular subgroups which were highly associated with histology. Subsequent further analysis of the serous cancers identified 3 subgroups with the dominant biology of one of these related to angiogenesis. This subgroup may be useful in identifying patients more ideally suited to treatment with anti-angiogenic therapeutics. This research will be presented at the Clinical Science Symposium entitled ‘Ovarian Cancer: Novel Approaches to Improve Treatment Outcomes’ on 4^th June at 1.15pm in McCormick Place Room E354a.

The second study to be presented was carried out in breast cancer. In this study, a molecular subgroup was discovered which is DNA damage response deficient. This has resulted in the generation of a signature which is capable of identifying patients who do not respond to standard DNA damaging chemotherapy with a very high negative predictive value and relative risk. It is proposed that this signature will be developed into a patient stratification tool for existing chemotherapy or a trial enrichment tool for DNA damaging or repair targeted drugs in development.  This research will be presented at a poster discussion session on 4^th of June at 5pm in McCormick Place Room S100bc.

Both studies were carried out using Almac’s proprietary Cancer DSA™ discovery arrays. These tools have been optimized to obtain data from FFPE samples.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business unit said:

“The ASCO meeting is always an important event in our calendar. We are very happy to have the opportunity to showcase some of our research at the meeting this year. Both of the studies being presented have significant clinical relevance and are likely to be of significant interest to both clinicians and the Pharma companies represented.”

Dr. Charlie Gourley of the University of Edinburgh Cancer Research UK Center, who will present the Ovarian cancer data said:

“As clinicians, we know from our day to day practice that ovarian cancer is a heterogeneous disease. This study shows that when patients are categorised according to the gene expression of their primary tumour that the 6 main subgroups which result have significantly different outcomes. Intriguingly, the gene expression profiles of some of the subgroups suggest that they may be particularly amenable to treatment with novel targeted agents such as anti-angiogenics. We are hopeful that this molecular classification will act as the template for the individualisation of ovarian cancer care based upon the biology of the patient’s tumour. ”

Ends….

Notes to Editors

About Almac

Almac’s Diagnostic Services business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.  Staff have now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac data to be presented at annual ASCO meeting appeared first on Almac.

The opening of the Almac CLIA Laboratory supports the company’s ongoing Biomarker Discovery and Development Strategy by enabling the use of novel tests to stratify and enrich prospective clinical trials.  This ability is of key importance as Almac begins to transition the novel biomarkers that they have developed into clinical use, with the resulting potential to inform the drug development process and target therapies to responsive patients.

In addition to standard molecular tests, Almac have a pipeline of both internal clinical tests and companion diagnostic tests with Pharma partners in development that will be delivered from the Almac CLIA Laboratory.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business said:

“We are very happy to announce the launch of our CLIA lab, which has been opened to meet both our needs and the needs for our Pharma partners. We have come to a point where the biomarkers we have discovered and assays that we have developed are being used to stratify patients, enrich clinical trials and impact patient treatment decisions. As such, CLIA is a key necessity for the processing of these samples.”

Almac’s genomics laboratories have been supporting biomarker discovery projects for 8 years and already operate under ISO17025 accreditation and work to the principles of GLP.

About Almac

Almac’s Diagnostic Services business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.  Staff have now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac open CLIA lab for biomarker clinical trials appeared first on Almac.

Click here to register now.

Speakers for this Event:

• Max Bylesjo, Ph.D., Bioinformatics Team Leader, Almac
• Nicolas Goffard, Ph.D, Bioinformatics Scientist, Almac

One of the main challenges of biomarker discovery is the unbiased evaluation and rational selection of most promising biomarkers suitable for independent validation. The absence of a robust evaluation procedure can result in selecting too many biomarkers (thus creating multiplicity problems) with biased and often too optimistic estimates of performance and with limited clinical utility.

Almac’s Approach

Almac has developed an integrated approach to biomarker model development, evaluation and selection and applied it to real life projects. This approach is implemented in classification workflow software. This allows for parallel development of multiple biomarkers models and simultaneous generation of the data used in the model evaluation procedure we are going to describe in this webinar. An important feature of this procedure is the use of both statistical and functional characteristics of the models evaluated.

While traditional approaches to biomarker model generation commonly focus on purely statistical properties, in this webinar we demonstrate how functional analysis can be used as both an essential component of biomarker discovery as well as integral part of the biomarker selection process.

Join this webinar and learn:

• How some of the major challenges of biomarker discovery can be addressed in an integrated manner.
• How to discover and select the biomarker models most suitable for independent validation.
• The importance of functional analysis as an essential component of biomarker discovery.

The post Live Webinar March 28th: An Integrated Approach to Biomarker Discovery appeared first on Almac.

Almac’s Bioinformatics consultancy supports discovery and development of biomarkers as well as enabling an in-depth understanding of biology by partnering with customers in the pharmaceutical, biotech and diagnostics setting from the initial study design through to the interpretation of data results.

The consultancy service offers a range of customisable bioinformatics and biostatistics solutions which include; Biomarker Discovery and Development, Exploratory Analysis, Mechanistic and Functional Analysis, Traditional and Next Generation Sequencing Data Analysis, Biostatistics and Data Integration.

The solutions are delivered through a large and experienced bioinformatics team from a wide range of disciplines including biology, medicine, mathematics and biostatistics. In addition to the team’s expertise in bioinformatics and biostatistics they also have substantial experience in molecular and cell biology, drug discovery and development and diagnostic product development.

Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Services business unit said:

“Bioinformatics has always been a key strength for us in Almac. Over the years we have built up a world class team of bioinformaticians and biostatisticians. This team has provided invaluable support for both our internal research and our external work. The launch of the full bioinformatics consultancy business is the next logical step in enabling our customer’s to access this important resource”.

Almac has secured its position in the personalized medicine market, following collaborations with some of the top Pharma companies worldwide including Pfizer, Eli Lilly and Merck.

Contact:

Emma O’Neill

Almac

028 38 33 7575

Emma.oneill@almacgroup.com

Almac’s Diagnostic Services business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Staff have now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac announce Launch of Bioinformatics Consultancy appeared first on Almac.

Click here to listen to podcast featuring Michael Sloan, VP Business Development (Almac’s Diagnostic Services division).

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,700 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 2008 and will be completed 2010.

Almac’s Diagnostic Services division is a personalised medicine company focused on the discovery and development of biomarkers. They utilise their proprietary technology and extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Almac Discusses New Biomarker Service on OutsourcingPharma.com appeared first on Almac.

Almac’s solutions are to support biopharma companies in adopting biomarker strategies to enable them to better understand their drug, improve their drug’s success rate, improve the drug’s value and ultimately maximise their drug’s potential.

The use of biomarkers can add substantial value to a compound in development and the ability to identify those patients most likely to respond to a therapy greatly increases the chances of success and the licensing potential of the drug.

Biomarkers for biopharma solutions include pharmacodynamic solutions, patient selection markers, assay development and bioinformatics / biostatistics consultancy.

President and Managing Director of Almac’s Diagnostic Services division, Professor Paul Harkin said:

“With Biomarkers for biopharma, we have combined a range of key solutions which are ideally suited to growing biopharma companies. For these companies, it is of critical importance that they maximise the potential success of the drugs in their pipeline and the incorporation of a biomarker strategy enables them to do this.”

Almac support and guide companies, enabling biomarker strategies that will maximise their drugs and business’s potential.

For further information on Biomarkers for biopharma visit almacgroup.com/biomarkersforbiopharma

End

Michael Sloan

Almac Diagnostic Services

michael.sloan@almacgroup.com

Tel :+44 28 38337575

Tristan Jervis

DeFacto

T.Jervis@Defacto.com

Tel: + 44 2078 613019

Notes to Editors

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,700 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 2008 and will be completed 2010.

Almac’s Diagnostic Services division is a personalised medicine company focused on the discovery and development of biomarkers. They utilise their proprietary technology and extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Almac launch Biomarkers for biopharma appeared first on Almac.

QUÉBEC CITY, June 28 /CNW Telbec/ – Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS), (the “Company”), a late-stage drug development company specialized in oncology and endocrine therapy, today announced a collaborative study with Almac’s Diagnostic Services division for the Company’s doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108, aimed at determining LHRH receptor expression through the development of a companion diagnostic tool. Selection for treatment with AEZS-108 is determined on the basis of LHRH receptor expression, currently measured immunohistochemically. In humans, LHRH receptors are expressed in ovarian, endometrial, breast, bladder, prostate and pancreatic tumors. AEZS-108 is currently in Phase 2 trials for advanced LHRH receptor positive ovarian and endometrial cancer.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, “We are very pleased with the collaboration with Almac who have proven experience in the development and validation of companion diagnostic tools and potential biomarkers in cancer indications. AEZS-108 is a promising anticancer compound, as demonstrated by the positive final Phase 2 results in ovarian cancer expressing LHRH receptors, recently disclosed at the last ASCO meeting. This state of the art companion diagnostic tool will allow us to develop improved methods of selecting the most appropriate patients to be treated with AEZS-108 in order to enhance the efficiency of our clinical trials and help us with the future successful development of AEZS-108 in a number of different LHRH expressing cancers.”

President and Managing Director of Almac’s Diagnostic Services division, Professor Paul Harkin, said “We are very pleased to collaborate with Aeterna Zentaris on this exciting project. The plan to develop a companion diagnostic for AEZS-108 shows Aeterna Zentaris’s clear commitment to personalized medicine, which will provide this compound with the best opportunity for success ”

About AEZS-108

AEZS-108, a doxorubicin LHRH receptor targeted conjugate, is currently in a Phase 2 trial in advanced ovarian and endometrial cancer. Positive final results in ovarian cancer were disclosed at this year’s American Society of Clinical Oncology (ASCO) meeting*, while final results in endometrial cancer are expected by year-end. AEZS-108 has been granted orphan-drug designation by the U.S. Food and Drug Administration and has received a positive opinion for Orphan Medicinal Product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of ovarian cancer.

An Investigational New Drug (IND) in the U.S. is in place for the treatment of bladder cancer.

Additional clinical studies in hormone-resistant prostate cancer and other cancer types are being planned. There may be benefits during the regulatory review process from the medical and scientific logic of this personalized treatment approach to patient selection and possibly have value in reimbursement considerations.

* Asco poster presentation: abstract #5035 entitled,

“Phase 2 study of AEZS-108, a targeted cytotoxic LHRH analog, in patients with LHRH receptor positive platinum resistant ovarian cancer.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,700 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 2008 and will be completed 2010.

Almac’s Diagnostic Services division is a personalised medicine company focused on the discovery and development of biomarkers. They utilise their proprietary technology and extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

Contact:

Michael Sloan

Almac Diagnostic Services

Michael.sloan@almacgroup.com

Tel :+44 28 38337575

About Aeterna Zentaris Inc.

Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are required by a governmental authority or applicable law.

Investor Relations

Ginette Vallières

Investor Relations Coordinator

(418) 652-8525 ext. 265

gvallieres@aezsinc.com

Media Relations

Paul Burroughs

Director of Communications

(418) 652-8525 ext. 406

pburroughs@aezsinc.com

The post Almac Announces Collaboration with Aeterna Zentaris to Develop Therapy and Companion Diagnostic in Cancer appeared first on Almac.

Almac’s proprietary Xcel™ array contains 92,000 transcripts, significantly more than is available on any other platform and the technology is optimised for use with Formalin Fixed Paraffin Embedded (FFPE) tissue.

Xcel™ array is a high density transcriptome based microarray built on the industry standard Affymetrix GeneChip® platform. The content of Xcel™ has been derived from high quality proprietary sequence data, as well as mining public gene expression and sequence databases. The design methodologies of the array are derived from validated methods used for Almac’s range of cancer DSA® (Disease Specific Arrays).

The substantial content on Almac’s Xcel™ array ensures that the platform technology is ideally suited for research in cross-disease areas, a notable advantage to pharmaceutical companies.

President and Managing Director of Almac Diagnostic Services, Professor Paul Harkin commented:

“Our Xcel™ array provides an ideal platform for the discovery of biomarkers in a range of diseases and where cross disease compatibility is important. This array becomes an important part of our solutions for the delivery of personalised medicine”

The Xcel™ array adds to Almac’s portfolio of proprietary discovery arrays which include; Breast Cancer DSA®, Colorectal Cancer DSA®, Lung Cancer DSA®, Ovarian Cancer DSA® and Prostate Cancer DSA®.

Ends

Michael Sloan

Almac Diagnostic Services

Michael.sloan@almacgroup.com

Tel :+44 28 38337575

Tristan Jervis

DeFacto

T.Jervis@Defacto.com

Tel: + 44 2078 613019

Notes to Editors

About Almac Diagnostic Services

Almac is a personalised medicine company focused on the discovery and development of biomarkers. They utilise their proprietary technology and extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,600 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Almac Launch Xcel Array – the Optimum Platform for Biomarker Discovery appeared first on Almac.

CRAIGAVON, NORTHERN IRELAND, 12 April 2010

Almac, Merck KGaA, Darmstadt, Germany, and the Medical Research Council (MRC), a UK-based, publicly-funded organization dedicated to improving human health, have entered into a partnership to undertake a study in metastatic colorectal cancer (mCRC) using samples from the MRC COIN trial. The aim of the study is to assess potential biomarkers of response to cetuximab (Erbitux®).

The value of biomarkers in optimizing treatment outcomes has already been recognized. The American Society of Clinical Oncology (ASCO) acknowledged in 2008 the use of the KRAS as a predictive biomarker for cetuximab in newly diagnosed advanced colon cancer as a “major research advance” that will “help guide treatment for each patient, increasing efficacy while eliminating unnecessary adverse effects in those who will not benefit from the treatment.”1

This personalized treatment approach was also recognized by regulatory bodies such as the European Medicines Agency (EMA) which approved cetuximab in combination with standard chemotherapy as a 1st-line treatment for mCRC in patients with KRAS wildtype tumors.

Almac will utilise samples from the COIN trial to carry out quantitative polymerase chain reaction profiling and data analysis to assess other potential biomarkers in the context of combination therapy with cetuximab.

Prof. Tim Maughan, Director, Wales Cancer Trials Unit, explained

“The MRC COIN trial is the largest trial of therapy in patients with advanced colorectal cancer and tested the addition of cetuximab to oxaliplatin based chemotherapy regimen. This collaboration will enable us to identify whether biomarkers apart from the Kras status alone further define which patients may benefit most from the addition of cetuximab to chemotherapy”

Prof. Paul Harkin, president of Almac Diagnostic Services, said;

“Almac are delighted to once again be involved in such an important study. The use of retrospective analysis from formalin fixed paraffin embedded samples will be one of the keys to successfully delivering better molecular diagnostics, which is paramount in the development of personalised medicine”

The MRC COIN study is a phase III, multicenter, three arm study in 1st-line treatment of mCRC. The study focuses on examining whether the combination of oxaliplatin and cetuximab with fluoropyrimidine chemotherapy improves patient outcomes.

Ends

1. Winer E, et al. J Clin Oncol 2009;27:812-26.

Contact:

Notes to Editors

About Almac Diagnostic Services

Almac Diagnostic Services is a personalized medicine company with particular expertise in companion diagnostic development, pharmacodynamic biomarkers, prognostic test development and drug target discovery. We have our own pipeline of IVD tests, which have been developed from FF & FFPE tissue. We utilize our experience, expertise and unique Cancer DSA™ technology to partner with our customers enabling translational genomic solutions.

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,600 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac partners with Merck KGaA and the MRC to assess markers of response to Cetuximab therapy appeared first on Almac.

Almac has shown significant growth in the last year, with employee numbers growing by 15% in the UK and 10% in the US. For the Diagnostic Services division, this trend continues through the expansion of the Bioinformatics Department and the subsequent opening of a dedicated bioinformatics facility in Manchester (UK).

Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services said:  “With our commitment to the delivery of personalized medicine, we have extended our bioinformatics group to increase our expertise in companion diagnostic development, pharmacodynamic (PD) biomarkers, disease classification and prognostic markers. Our extended expert bioinformatics capability assists our dedication to the advancement of patient care through translational genomic solutions”

Almac’s Bioinformatics group specialise in gene selection, disease characterisation and classification. Bioinformatics is well recognised as a major bottleneck in genomics and the expansion of the bioinformatics group greatly expands Almac’s capacity and hence reduces this problem.

Click Here to View Video with Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services.

-Ends-

Contact:

Emma O’Neill

Almac Diagnostic Services

T: + 44 (0) 2890 38332200

E: diagnostics@almacgroup.com

Carl@stakeholdergroup.com

Carl Whyte

Stakeholder Communications

T: + 44 (0) 2890 339949

Notes to Editors

About Almac Diagnostic Services

Almac Diagnostic Services is a personalized medicine company with expertise in companion diagnostic development, pharmacodynamic biomarkers, prognostic test development and drug target discovery. We have our own pipeline of IVD tests, which have beendeveloped from FF & FFPE tissue. We utilize our experience, expertise and unique Cancer DSA™ technology to partner with our customers enabling translational genomic solutions.

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,500 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

< Back to News Page

The post Bioinformatics Expansion Heralds Further Growth for Almac appeared first on Almac.

The study focuses on evaluating Thymidylate Synthase (TS) as a predictive marker of response to Alimta in combination with cisplatin. A number of parallel exploratory analyses will be performed as alternative strategies to identify further potentially novel predictive biomarkers of response to the combination therapy. These include global gene expression profiling from FFPE tumour samples using the Almac Diagnostic Services Lung Cancer DSA™ research tool.

Paul Harkin, president of Almac Diagnostic Services, explains; “Almac is focussed on enabling personalised medicine. Our core expertise is in the discovery and validation of both prognostic and predictive biomarkers. We have a specific expertise in the development of biomarkers from FFPE tissue and are very happy to announce this partnership with Lilly.”

The project will involve a multi-center, single arm Phase II study that will recruit patients diagnosed at stage IIIB/IV.  Almac’s technical team will perform global gene expression profiling, microRNA profiling, SNP genotyping, qPCR validation as well as data analysis and  project management of the study. The final endpoint will be the development of a companion diagnostic test that will select patients likely to benefit from treatment with ALIMTA.

-Ends-

Notes to Editors

Almac Diagnostic Services Lung Cancer DSA™ research tool

This high density array has been developed through a combination of in-house sequencing and data mining to create the unique information content. It is the first microarray based on the transcriptome of an individual disease and so will maximise the data selected from the specific disease setting allowing Lilly to obtain significantly more reliable and relevant gene expression information that would not be available on a generic array.

About Almac Diagnostic Services

Almac Diagnostic Services is a personalised medicine company providing translational genomic based solutions for pharma, biotech and academic customers. Almac specialises in working with fresh and formalin fixed paraffin embedded (FFPE) tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,500 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”.  US operations are based in Pennsylvania, North Carolina and California.  Construction of the company’s new $112m North American Headquarters in PA started in July 08 and will be completed in 2010.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

For further information contact:

Michael Sloan

Almac Diagnostic Services

T: + 44 (0) 2890 38337575

Carl Whyte

Stakeholder Communications

T: + 44 (0) 2890 339949

< Back to News Page

The post Almac and Lilly Partner on Companion Diagnostic Development appeared first on Almac.

The $725,000 research grant over two years will allow Lisa Baumbach, Ph.D., Associate Professor of Pediatrics at the MillerSchool, and Mark Pegram, M.D., Professor of Medicine and Associate Director for clinical and translational research at the Braman Family Breast Cancer Institute at Sylvester, to expand their earlier work and examine the genetic differences found in African-American breast cancer patients.

Baumbach and Pegram’s study utilizes Almac’s Cancer DSA™.   The Almac Cancer DSA™ is the first high-density microarray to focus on the transcriptome of a particular disease and as a result contains significant, additional and relevant information.  The tool has been designed to enable profiling from both frozen and FFPE tissue which allows application of this unique microarray technology to current clinical practice and retrospective tissue banks.

Professor Paul Harkin,President of Almac Diagnostic Services explains that; “the Almac Diagnostic Services Breast Cancer DSA™ research tool offers the most comprehensive gene expression analysis platform for the study of breast cancer with over 60,000 biologically relevant transcripts available for interrogation.”

The UM teams preliminary findings showed ethnic-specific gene expression patterns in African-American women.  Using breast cancer tissue samples, they will now compare genome expression in African-Americans with naturalized African women, examining 50 women in each group.  In addition, Baumbach and Pegram will also analyzechromosomal alterations associated with gene expression differences.

Lisa Baumbach, Ph.D., Associate Professor of Pediatrics at the MillerSchool said:” Recent discoveries  using the Almac Breast Cancer DSA™ indicate there may be distinct genetic differences in breast tissue between African-American, Caucasian and Hispanic patients.  The new grant will allow the UM team to take those findings a step further, with an international collaboration on women of African descent.”

Baumbach stated that Almac’s particular expertise in working with FFPE samples has opened up a wealth of potential information; “determining the exact genetic differences in breast tissue samples of certain ethnicities could have worldwide ramifications in terms of reducing the global burden of breast cancer by developing more effective preventions and treatments.”

Breast cancer is the second leading cause of cancer death among African-American women, and for this ethnic group, carries a 20 percent greater mortality than that of Caucasian women.  Among the scientific community it is widely acknowledged that African-American women, regardless of their age, are more likely to have triple negative breast cancer. In addition, it is likely to occur at an earlier age, and have a higher proliferative fraction. All these factors add up to a worse prognosis.

Baumbach said: “There is a clear need for us to better understand the genetic differences in women of African ancestry so we can translate that into more effective guidelines and therapies.”

Agreeing with his colleague Pegram concluded: “We hope to identify the genes or molecular alterations that are causing these differences among ethnic groups. Once that happens, the goal is to identify a potential therapeutic target to personalize therapeutic approaches.”

-End-

Contact:

Michael Sloan

VP Business Development

Almac Diagnostic Services

T: + 44 (0) 28 38337575

E: diagnostics@almacgroup.com

Carl Whyte

Stakeholder Communications

T: +44(0)2890 339949

E: carl.whyte@stakeholdergroup.com

Notes to Editors

About Almac Diagnostic Services:

Almac Diagnostic Services is personalised medicine company whose core expertise is in the provision of genomic-based solutions.  Almac utilise their experience, expertise and unique Cancer DSA™ technology to partner with customers enabling translational genomic solutions for personalised medicine.  Current developments include a pipeline of genomics based IVD tests, all of which have been developed from FFPE tissue.

Almac Diagnostic Services has received support from Invest NI and the European Regional Development Programme.

About the Breast Cancer DSA™ research tool:

Almac Diagnostic’s range of Cancer DSA™ research tools are microarrays developed to enable accelerated research in discovery, development and validation and ultimately to deliver clinical applications.

As the first microarray based around the transcriptome colorectal cancer, the Breast Cancer DSA™ research tool generates significantly more information, which is reliable and relevant to the disease of interest, than is available on a generic array.

Array content has been generated through a process of sequencing, gene expression profiling and mining of public databases followed by extensive bioinformatics analysis to create and annotate the unique, comprehensive coverage of the breast cancer transcriptome. This provides researchers with all the information required to draw meaningful conclusions from their experimental data.

Based upon the gold standard Affymetrix GeneChip technology, the DSA™ research tools provide multiple independent measurements for each transcript and content is both reliable and reproducible.

About Almac Group:

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS and Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,400 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

< Back to News Page

The post UM Breast Cancer Researchers partner with Almac to win prestigious Department of Defense Grant appeared first on Almac.

The headquarters of Almac Diagnostic Services, a division of the Almac Group, was officially opened today by renowned oncologist Dr Martin Murphy. Almac Diagnostic Services is based within the company’s headquarters in Craigavon, Northern Ireland with additional facilities in Durham, North Carolina. Almac Chairman Sir Allen McClay has hailed today’s opening as a ‘significant step forward for Almac.’

Alongside Dr Murphy, other guests included Upper Bann MP David Simpson, Meta Crozier the Mayor of Craigavon, Managing Director of Clients & Entrepreneurship Group for Invest NI, Ian Murphy and other business representatives.

Welcoming the guests Group Chairman Sir Allen McClay said: “This is a milestone day for Almac which cements our position as a world leading pharmaceutical and biotech service company. The Diagnostics Services division develops and delivers genomic solutions for the advancement of science and the improvement of patient care. From our base here in Northern Ireland we are making a major contribution in particular to cancer research. We have a strong relationship with Dr Martin Murphy who has been a friend to Almac since we were founded. It is an honour and a pleasure to have this building dedicated to Dr Murphy and to host him and his family today.”

Dr Murphy said: “The fight against cancer is an international crusade which is led by talented, energetic and committed people and organisations. One of those organisations is Almac and I am honoured to have worked with the people behind this organisation for a number of years. The people of Northern Ireland really should be proud of the work which goes on at this site. It is no exaggeration to say that thanks to those working at Almac, Northern Ireland is now at the forefront of cancer research. I want to thank Sir Allen McClay, Professor Paddy Johnston and all of their colleagues for their support and I am proud to open the Marty Murphy building.”

-End-

Contact:

Carl Whyte

Stakeholder Communications

T: +44(0)2890 339949

E: carl.whyte@stakeholdergroup.com

Notes to Editors

About Dr Martin Murphy:

Dr Murphy is the Founding Executive Editor of the thirteen-year-old international, peer-reviewed journal, The Oncologist. He is a member of the International Board of Advisors of the H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, a member of the Queen’s University-Belfast Medical School International Review Panel, director of the Foundation for the National Institutes of Health, the American Society of Clinical Oncology Foundation, a co-founder of the All-Ireland Cancer Foundation, and a charter member of C-Change co-chaired by former President George Bush and former First Lady Barbara Bush

About Almac Diagnostic Services:

Almac Diagnostic Services is a personalised medicine company whose core expertise is in the provision of genomic-based solutions. Almac utilise their experience, expertise and unique Cancer DSA™ technology to partner with customers enabling translational genomic solutions for personalised medicine. Current developments include a pipeline of genomics based IVD tests, all of which have been developed from FFPE tissue.

Almac Diagnostic Services has received support from Invest NI and the European Regional Development Programme.

About Almac Group:

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS and Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,400 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Official opening of Almac Diagnostic Services headquarters appeared first on Almac.

Ahead of his talk, Dr Tanney took some time out to share his viewpoints with leading Genomics Journal, GEN.

Dr. Tanney comments on the challenges and issues involved in fine tuning sample preparation techniques to ensure high quality data and optimize RNA and DNA extraction.  He explains that advances in technology to enable DNA and RNA extraction are advancing the field.

“There are quite a few challenges,” comments Austin Tanney, Ph.D., scientific liaison manager, Almac Diagnostic Services . “But there are a number of really good reasons to work in this space, one of the chief reasons being what this can mean for personalized medicine.”

“One of the reasons we work with FFPE is that there are literally hundreds of thousands of samples available¿a huge amount of information to work with,”

“Doing retrospective studies can cut off years of development time for a diagnostic. What is most important, however, is that if a diagnostic test works from FFPE there is no required change to clinical practice to use this test. This is not a case when the test must be carried out on fresh frozen material.”

Almac has been able to use what they have found in FFPE samples to advance cancer studies.

“Cancer has always had a one-size-fits-all treatment regimen, even though it’s a heterogeneous disease,” continues Dr. Tanney. “Clearly, this is an area where treatment can be personalized”

For the full article see on http://www.genengnews.com/articles/chitem.aspx?aid=2876

-END-

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture.

The company has over 2,400 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

Construction of the company’s new $112m North American Headquarters commenced in July 2008 and is expected to be completed in 2010. Almac was awarded the Belfast Telegraph ‘Business of the Year’ award in 2009.

To find out more about Almac visit almacgroup.com.

< Back to News Page

The post Dr Tanney Discusses Challenges Faced in Fine Tuning Sample Preparation Techniques appeared first on Almac.

In addition, Almac has implemented a replicated HP StorageWorks XP Disk Array solution, the first of its kind in Northern Ireland. The array provides Almac with a scalable data storage capacity that is expected to handle the demands of the business for at least the next five years.

Every drug under development must be scrutinized in a clinical trial, which requires customized software applications that go through a complex compliance and validation process before the trial can proceed. By using HP Quality Center software to automate the testing process for these applications, Almac has reduced the validation time by months, which means that drugs for cancer and other illnesses can get to patients faster.

“By using HP technology we help speed the move from innovation to clinical practice, resulting in significant market advantage and enhanced competitiveness for our customers across the world,” said Sir Allen McClay, chairman, Almac Group. “Our 15-year relationship with HP has extended far beyond hardware and software; we are engaging with people who can bring innovative technology solutions to science and produce something mutually beneficial.”

Almac has achieved full Pharmaceutical Validation for HP Quality Center software, enabling it to automate its approach to software validation and testing. Almac’s achievements in applying the technology in the pharmaceutical sector were recently showcased at a global ICT summit on software in Vienna, Austria.

“HP is helping Almac shorten the validation aspects of its software development while at the same time ensuring that it can meet manufacturing best practices globally,” said Martin Murphy, managing director, Northern Ireland, HP. “HP Quality Center software helps IT organizations save time and deliver applications that do exactly what the businesses need.”

-END-

About HP

HP, the world’s largest technology company, simplifies the technology experience for consumers and businesses with a portfolio that spans printing, personal computing, software, services and IT infrastructure. More information about HP (NYSE: HPQ) is available at http://www.hp.com.

Note to editors: More news from HP, including links to RSS feeds, is available at http://www.hp.com/hpinfo/newsroom/.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

The company has almost 2,400 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters started in July 08 and is expected to be completed 2010.

To find out more about Almac visit almacgroup.com or e-mail info@almacgroup.com. This news release contains forward-looking statements that involve risks, uncertainties and assumptions. If such risks or uncertainties materialize or such assumptions prove incorrect, the results of HP and its consolidated subsidiaries could differ materially from those expressed or implied by such forward-looking statements and assumptions. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but not limited to statements of the plans, strategies and objectives of management for future operations; any statements concerning expected development, performance or market share relating to products and services; any statements regarding anticipated operational and financial results; any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. Risks, uncertainties and assumptions include macroeconomic and geopolitical trends and events; the execution and performance of contracts by HP and its customers, suppliers and partners; the achievement of expected operational and financial results; and other risks that are described in HP’s filings with the Securities and Exchange Commission, including but not limited to HP’s Annual Report on Form 10-K for the fiscal year ended October 31, 2008. HP assumes no obligation and does not intend to update these forward-looking statements.

© 2009 Hewlett-Packard Development Company, L.P. The information contained herein is subject to change without notice. The only warranties for HP products and services are set forth in the express warranty statements accompanying such products and services. Nothing herein should be construed as constituting an additional warranty. HP shall not be liable for technical or editorial errors or omissions contained herein.

The post Almac Group Uses HP Technology to Bring New Drugs to Market Faster appeared first on Almac.

The award was presented for work on their Ovarian Cancer DSA™ research tool. The product is the first high-density disease focused transcriptome based microarray for the study of ovarian cancer. With over 100,000 transcripts derived from ovarian tissue, the Ovarian Cancer DSA™ research tool represents the most complete platform available for the study of ovarian cancer.

Managing Director of Almac Diagnostic Services and Professor of Molecular Oncology within the Cancer Research Center at Queen’s University Belfast, Professor Paul Harkin said; “I am delighted with this recognition by the Cambridge Healthtech Institute. The Ovarian Cancer DSATM adds to our Cancer DSATM range of microarray based research tools, enabling further discovery in cancer research.

“Our Ovarian Cancer DSA™ has the potential to lead to the development of targeted therapies to tackle ovarian cancer,” he added.

Almac have also developed DSA™ research tools for colorectal, lung, breast and prostate cancer.

The news comes one week after Almac won the Invest Northern Ireland ‘Exporter of the Year’ award for outstanding export achievement and growth. The award follows a successful 2008 for the organisation which generates over 70% of its sales from export.

ENDS

Notes to the Editor:

About Almac Diagnostic Services:

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academia. Almac specialises in working with fresh and FFPE tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac Group:

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,400 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters started in July 08 and is expected to be completed 2010. For more information about the Almac Group, please visit almacgroup.com.

About Cambridge Healthtech Institute (CHI)

Founded in 1992, Cambridge Healthtech Institute (www.chicorporate.com) is the pre-eminent life science network for leading researchers and business experts from top pharmaceutical, biotech, academic, and niche service provider organizations. CHI’s integrated life science portfolio of products and services includes Cambridge Healthtech Institute Conferences, Pharmaceutical Strategy Series, Barnett International, Insight Pharma Reports, Marketing Services, Meeting Planners, and Cambridge Healthtech Media Group, which includes numerous eNewsletters, Bio-IT World magazine, as well as Lead Generation Programs.

Contact

Carl Whyte

Stakeholder Communications

02890 339949

Joseph Cushley

Almac Diagnostic Services

028 3839 7575

diagnostics@almacgroup.com

< Back to News Page

The post Almac Collect Top Recognition for New Ovarian Cancer Research Product appeared first on Almac.

San Carlos, Calif. and Craigavon, United Kingdom. NuGEN Technologies, Inc., a leader in nucleic acid sample preparation and Almac Diagnostic Services, provider of translational genomics-based solutions, announced today that Almac has added NuGEN Ovation® Systems to its gene expression profiling services, to address the challenges of analyzing valuable, irreplaceable clinical samples. In addition, Almac has also chosen to use Ovation Systems in its own development of genomics-based diagnostic tests.

Dr. Paul Harkin, President and Managing Director of Almac Diagnostic Services, explained how working with formalin-fixed, paraffin-embedded (FFPE) tissue samples is the foundation of Almac’s approach to the development of diagnostic tests. The Single Primer Isothermal Amplification (SPIA®) technology from NuGEN coupled with Almac Cancer DSA™ microarray platform offers a unique solution to working with this degraded material.

Almac has built a pipeline of genomics-based prognostic tests that include a prognostic test for stage II colorectal cancer and a prognostic test for stage I lung cancer. In addition, Almac also has companion diagnostics in development with their pharma and biotech partners. Ovation Systems will be utilized to support the development of both types of tests.

The family of Ovation RNA amplification and labeling products from NuGEN enables sensitive and robust gene expression profiling from small or degraded samples, such as FFPE tissues, whole blood, tissue biopsies, lasercaptured micro-dissected cells, and sorted cells. Since Ovation Systems are platform-independent, researchers may conduct downstream analyses using their preferred gene expression platform.

“The combined power of NuGEN Ovation Systems and Almac Cancer DSA™ microarray platform enables Almac to quickly and easily deliver reliable results from precious clinical samples. In addition, Almac’s choice of using Ovation Systems in its own clinical and diagnostic applications is testament to their confidence in the SPIA technology,” said Dr. Sue Pandey, NuGEN vice president of field operations. Pandey also noted that NuGEN worked diligently to achieve ISO 13485:2003 certification in early 2008 for its quality management systems, which is particularly important for supporting customers in meeting mandated regulatory requirements in some of the clinical studies.

Almac will initially offer Ovation Systems for its RNA amplification and target preparation services for FFPE and whole blood samples using the following established workflows:

• WT-Ovation™ FFPE Solution: A complete target preparation solution that enables global gene expression analysis of vast archives of degraded RNA derived from FFPE samples with as little as 50 ng of total RNA.
• Ovation® Whole Blood Solution: A target preparation solution that enables global gene expression analysis from 20 ng of whole blood RNA without the need for globin reduction procedures.

Customers may immediately engage Almac for gene expression analysis and test development using NuGEN products. For pricing and availability of Almac services using NuGEN Ovation Systems, contact Almac at:

For European Enquiries

19 Seagoe Industrial Estate

Craigavon

B63 5QD

United Kingdom

T: +44 (0) 28 3833 7575

F: +44 (0) 28 3839 8676

For North American Enquiries

801-1 Capitola Drive

Durham, NC27713

T: +1 (919) 294 0230

F: +1 (919) 544 8420

About NuGEN

NuGEN Technologies, Inc. based in San Carlos, CA, is focused on the development and commercialization of sensitive, rapid, and high-throughput amplification and sample preparation systems to enable the comprehensive analysis and discovery of biological mechanisms, cellular responses, and disease pathologies.

About Almac Diagnostic Services

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academia. Almac specializes in working with fresh and FFPE tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

For more information about the Almac Group, please visit almacgroup.com

NuGEN, Ovation, SPIA and Ribo-SPIA are registered trademarks of NuGEN Technologies, Inc. WT-Ovation, FLOvation, and Imagine More From Less are trademarks or service marks of NuGEN Technologies, Inc. Almac Diagnostic Services DSA and Almac Cancer DSA are all trademarks of Almac Diagnostic Services Limited. All other marks are the property of their respective owners.

The post Almac Selects NuGEN Ovation® Systems to Broaden Gene Expression appeared first on Almac.

The M.D. of Almac Diagnostic Services Professor Paul Harkin will present at the forthcoming event as a key speaker on Biomarkers in Prognosis and treatment. Professor Harkin will outline how Almac’s cutting edge technology can accelerate the rapid delivery and development of diagnostic, prognostic and predictive tests to improve the management of cancer patients’ treatment.

The All Ireland Cancer conference, now in its 4th year will include a multi-disciplinary overview of the latest advances in cancer care, from prevention through treatment to end-of-life care, including topics as diverse as communication skills and genome-wide association studies.

As well as M.D. of Almac Diagnostic Services, Paul Harkin is a Professor of Molecular Oncology within the Cancer Research Center at Queen’s University Belfast.  His research has been published in some of the world’s leading research journals including Cell, Nature Genetics and The Journal of the National Cancer Institute, and Lancet. He also is represented on several National committees and funding boards and acts as a reviewer for a number of major research journals. Speaking about the event he said:

“The advent of high throughput genomic-based technologies has created new opportunities to aid our understanding of the molecular basis of cancer. These technologies are also being harnessed to develop new diagnostic, prognostic and predictive tests that are likely to have a dramatic positive impact on the management of cancer patients’ treatment”.

“At Almac, we are at the cutting edge of technology in this area and work across drug development, target identification, companion diagnostics and predictive and prognostic tests with the aim of aiding research into and improving personalised medical care for cancer patients .”

The conference is organised by the Ireland-Northern Ireland-National Cancer Institute and has attracted internationally renowned speakers in the many areas of basic science, clinical care, cancer nursing, health services research and prevention from North America, Ireland and the UK.

Notes to the Editor:

About Almac Diagnostic Services:

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academia. Almac specialises in working with fresh and FFPE tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac Group:

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company has over 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit almacgroup.com.

Ends…

Emma O’Neill

Almac Diagnostic Services

028 3839 7575

The post Almac addresses leading cancer specialists at All-Ireland conference appeared first on Almac.

Ovarian cancer is considered one of the most dangerous gynaecological cancers among women worldwide and is the rated the fourth most common cancer in women in the UK.

Almac Diagnostic Services have developed a range of disease focused transcriptome based microarrays or DSA™ (disease specific array) research tools that are designed for use in specific cancers. Almac’s latest DSA™ is the first microarray based on the transcriptome of ovarian cancer and is designed on the Affymetrix Genechip™ platform, ensuring reliable and reproducible results.

The array was generated by a combination of extensive in-house sequencing and public data mining and as a result contains tens of thousands of transcripts not available on conventional arrays. The ability to work with both frozen and FFPE tissue combined with the disease-targeted content, means this is the most focused and biologically comprehensive platform for studying ovarian cancer now available.  The ability to profile from FFPE also enables application to both current and retrospective tissue banks.

The Ovarian DSA™ contains probesets representing mitochondrial transcripts, antisense transcripts, alternatively polyadenylated transcripts and novel transcripts.  It will offer researchers the ability to reveal the mechanisms and pathways underlying ovarian cancer as well as to classify and sub-classify the disease and develop diagnostic, prognostic and predictive signatures.

Ultimately this could lead to clinical applications such as the development of targeted therapies and thus increasing survival rates and decreasing the number of patients receiving unnecessary or ineffective treatments.

Prof. Paul Harkin President and M.D. of Almac Diagnostic Services said:

“With over 6,000 cases of ovarian cancer diagnosed in the US every year, the application of our DSA™ technology will not only ensure a greater understanding of the mechanisms of the disease, but also improve the provision of solutions for the oncology market and the progression of targeted treatment for the advancement of patient care. Our Ovarian DSA™ is now the most advanced platform for studying ovarian cancer and could ultimately lead to the development of targeted therapies to tackle the disease”.

To date Almac have developed DSA™ research tools for colorectal, lung, breast, prostate and ovarian cancer.

Ends

Contact:

Michael Sloan

Almac Diagnostic Services

Tel: + 44 (0) 28 38392200

Carl Whyte

Stakeholder Communications

Tel: + 44 (0) 2890 339949

Notes to Editors:

About Almac Diagnostic Services:

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academia. Almac specialises in working with fresh and FFPE tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac Group:

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company has over 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new £100m North American Headquarters started in July 08 and is expected to be completed late 2010.

For more information about the Almac Group, please visit almacgroup.com.

The post Almac Diagnostic Services Launches Ovarian Cancer Research Tool appeared first on Almac.

The aim of the study is to generate a gene expression signature that will allow clinicians to stratify patients with early NSCLC (Stages I and II) into those who will relapse after surgery and those who will have disease free survival with surgery alone. This gene signature will form the basis of a clinical test to identify patients at high risk of lung cancer recurrence after surgery and who may therefore benefit from adjuvant treatment.

The study will utilise Almac’s unique Cancer DSA™ technology; a proprietary microarray platform designed to measure gene expression in archived FFPE (formalin fixed paraffin embedded) tissue. This microarray platform identifies tens of thousands of transcripts that are specific to lung cancer and not available on conventional commercial arrays.

The use of FFPE tissue samples will enable Almac to retrospectively generate and validate this powerful prognostic test.  This has clear clinical utility, as frozen tissue is not routinely collected during surgery.

To date most prognostic gene expression signatures have been developed using relatively small numbers of samples. The benefit of being able to access large numbers of archive samples retrospectively is the ability to identify molecular sub types which are likely to influence patient’s prognosis.

Professor Paul Harkin President and Managing Director of Almac Diagnostic Services explained: “This is the largest transcriptional study of its type and has the potential to benefit many thousands of patients worldwide. Our microarray technology means we can now access a wide range of genetic material, previously not available through commercial array analysis, in order to validate prognostic tests. This fits in with Almac’s vision to be the global leader in the provision of translational genomic based solutions for the advancement of patient care”.

Dr. Dean A. Fennell, the Academic Lead on the study from the Center for Cancer Research and Cell Biology at Queen’s added: “Lung cancer is a global health burden and it accounts for around 30% of cancer deaths in the USA and Europe. Prognosis following diagnosis of NSCLC, the most common form of the disease in 80% of patients, remains abysmal with an overall 5-year survival of only 10-15%, a figure which has not changed in decades. However one fifth of patients have early stage NSCLC that is potentially curable following surgery which results in 5-year survival rate of 40-82%, depending on the tumour size and the degree of local invasion. “While it is now accepted that the use of adjuvant chemotherapy reduces the risk of recurrence in a minority of patients no routinely used molecular test exists to select those patients at a high risk of recurrence. This large scale gene expression study will generate the first such test capable of identifying patients with high risk NSCLC. It is anticipated that submission to International regulatory bodies for approval will occur by 2010 to enable its routine implementation in the clinic.” he added.

Professor Giorgio Scagliotti, University of Turin, Department of Clinical and Biological Sciences and leading world expert on Lung Cancer said:

“Potentially this study will generate data easily applicable to clinical practice and will hopefully lead to a much better treatment optimisation for our patients”

Contact:

Michael Sloan

Almac Diagnostic Services

T: + 44 (0) 2838 337575

diagnostics@almacgroup.com

almacgroup.com/diagnostics

Brendan Mulgrew

Stakeholder Communications

T: + 44 (0) 2890 339949

NOTES TO EDITOR:

About Almac Diagnostic Services:

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academic customers. Almac specialises in working with fresh and FFPE tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac Group:

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company has over 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit almacgroup.com.

About Cancer DSA™ Technology:

Almac has developed a range of Cancer DSA™ research tools to facilitate the provision of solutions for the oncology market. The Cancer DSA ™ research tools are the first high-density transcriptome based microarrays which focus on the transcriptome of a particular disease. They contain the most comprehensive information available for the disease under investigation on a single array and enable the obtaining of robust data from FFPE and FF sample, while delivering additional information on the disease setting.

The following DSA™ research tools are now available: Lung DSA™, Ovarian DSA™, Colorectal DSA ™, Breast DSA™ & Prostate DSA™.

About the study:

Collaborators in the study include Queen’s University Belfast, University of Turin, St. James Hospital, Dublin University of Texas MD Anderson Cancer Center, Royal Brompton and Harefield Hospital London and Saccomanno Research Institute at St. Mary’s Hospital & Medical Center, Grand Junction, Colorado and Guy’s & St Thomas NHS Foundation Trust.

The post Almac Announce World’s Largest Gene Expression Study To Develop Prognostic Test for Early Non Small Cell Lung Cancer appeared first on Almac.

The Coalition is an independent non-profit group comprised of leading academic, industrial, patient and provider organizations that are dedicated to the advancement, understanding and adoption of personalized medicine. The group provides leadership surrounding the issue and serves as a forum for discussion, education and advocacy.

Professor Paul Harkin, President and Managing Director of Almac Diagnostic Services said:  “At Almac we are committed to the advancement of patient care through translational genomic solutions. We believe we can positively contribute to the progression of personalized medicine through our expertise in biomarker discovery and validation, bioinformatics solutions and genomic services including our proprietary Cancer DSA™ technology.  We are looking forward to working alongside other like-minded organizations and playing a role in the acceleration of personalized medicine and ultimately its benefits to patient care”.

Edward Abrahams, Executive Director of PMC added:  “The PMC is especially pleased that Almac Diagnostic Services has joined its efforts to create a friendlier landscape for the advancement of personalized medicine. The PMC seeks to expand its international focus, and Almac Diagnostic Services is well positioned to contribute to that goal.”

Since its launch in 2004, the coalition has grown to over 140 members, providing a forum for the public, policymakers, government officials and private sector healthcare leaders to further the public interest in personalized medicine and identify policies which will accelerate its adoption. The PMC has engaged with a wide range of organisations, including the FDA, National Human Genome Research Institute and the Center for Medicare and Medicaid Services among others.

Ends

Contact:

Emma O’Neill

Almac Diagnostic Services

T: + 44 (0) 2838 337575

Carl Whyte

Stakeholder Communications

T: + 44 (0) 2890 339949

Notes to Editors

About Almac Diagnostic Services

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academic customers. Almac specialises in working with fresh and formalin fixed paraffin embedded (FFPE) tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company has over 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit almacgroup.com.

About Personalized Medical Coalition

The Personalized Medicine Coalition, representing a broad spectrum of academic, industrial, patient, provider and payers communities, sees to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients.

Further information at www.personalizedmedicinecoalition.org

The post Almac Diagnostic Services Join Personalized Medicine Coalition appeared first on Almac.

The Almac Group today announced a deal with Biogen Idec Inc (NASDAQ: BIB) a global biotechnology company based in Cambridge, Mass., to use Almac Diagnostic Services’ expertise in extracting genetic information from formalin fixed paraffin embedded tissue (FFPE) for SNP analysis in a Phase II trial of one of its drug candidates for the treatment of gastrointestinal stromal tumors (GIST).

Almac Diagnostic Services has developed unique capabilities to work with FFPE that allow researchers to use the samples in qPCR and microarray SNP genotyping and gene expression studies. Previously, such genetic analyses were not routinely possible in clinical trials due to degradation of the tissue samples during fixation and storage. This service is now available from Almac’s two facilities in Europe and the US.

Most clinical material is stored as FFPE tissue blocks, which, in the past, rendered the material unsuitable for genetic analysis. Almac has developed a proprietary process that now makes it possible to unlock the genetic information stored within these samples. The newly validated process enables qPCR and microarray SNP genotyping from FFPE samples. This process will be used in the Biogen Idec clinical trial.

Professor Paul Harkin, President and MD, Almac Diagnostic Services said: “Our validated processes have led to a huge shift in conventional thinking in how we handle the genetic information trapped in the nearly 400 million FFPE samples worldwide. Our approach means that we can now access a wide range of genetic material for analysis now and in the future. Harnessing and accessing the genetic information in clinical samples will change the way pharmaceutical and biotech companies examine results from their clinical trials. These developments will enable researchers to make significant advances towards personalised medicine.”

Julie Ranuio-Kelley, Senior Associate Scientist at Biogen Idec said: “This newly validated approach means that we can now access the full genetic information contained in our clinical trial samples. This will allow us to uncover biomarkers that will help us discover additional drug candidates and identify specific patient populations that will benefit from a particular treatment.”

Ends

Contact: Michael Sloan

T: + 44 (0)28 3833 7575

Matt Nelson

T: + 1 415 797 2607

About Almac Diagnostic Services

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academic customers, and specialises in working with fresh and formalin fixed paraffin embedded (FFPE) tissue. They partner with customers for biomarker discovery and validation, and provide bioinformatic solutions and genomic services. Almac Diagnostic Services have also developed their range of Cancer DSATM  research tools, the first disease specific transcriptome based microarrays.

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including world leaders in the pharmaceutical and biotech sectors. The company has 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit almacgroup.com.

Forward-looking Statements

All statements in this press release that are not historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Biogen Idecs’ “expectations,” “beliefs,” “hopes,” “intentions,” “strategies” or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Biogen Idec from those projected, including, but not limited to: risks and uncertainties relating to commercial success of the agreement with Almac Diagnostic Services discussed in this press release; risks of the company’s ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses; uncertainties related to technological approaches, manufacturing and product development; personnel retention; uncertainties related to cost and pricing of Biogen Idec products; dependence on collaborative partners; uncertainties related to sole-source suppliers; risks associated with past and future acquisitions; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Biogen Idec’s Form 10-K for the year ended December 31, 2006, and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Biogen Idec expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Biogen Idec’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

The post Almac Diagnostic Services in new deal to provide unique process to extract genetic information from Clinical Trial samples appeared first on Almac.

Almac, formerly known as ArraDx, signed an initial agreement with Affymetrix in 2005 to develop tests for breast cancer and colon cancer.  Now the company has obtained the right to develop prognostics and diagnostics for all cancer areas with a long-term contract that the firm said will raise its profile among potential biotech and pharmaceutical customers.

“It was important to us to expand our product portfolio [so] that we had the right [to develop tests] for all cancer areas,” Paul Harkin, president and managing director of Almac Diagnostic Services, told BioArray News last week. “This means that we can move forward with our own internal in vitro diagnostics portfolio.”

Almac has designed a line of disease-specific arrays, or DSAs, for a number of conditions, including breast, colorectal, lung, prostate, and ovarian cancers, that it sells as research tools with a long-term goal of developing them into diagnostics.

The firm currently has three gene-expression signature-based tests in its pipeline based on the DSAs that could become commercially available within the next two to three years. The most advanced test is for stage 2 colorectal cancer recurrence and Almac is preparing to submit the assay for 510(k) clearance by the US Food and Drug Administration sometime next year.

In addition to the stage 2 colorectal cancer recurrence test, Almac also has diagnostics in development for stage 1 lung cancer and ductal carcinoma in situ, an early stage of breast cancer. Almac is collaborating with Cancer Research UK on a discovery project related to DCIS.  Depending on the launch of the colorectal test, Harkin said it is possible that both the lung cancer test and the test for DCIS could become available during 2010.

All of Almac’s DSAs are designed to work with tissue from formalin-fixed, paraffin-embedded samples — an attribute that Harkin said has allowed the firm to line up a number of collaborators as its first three assays make their way to market.

In terms of the colorectal cancer recurrence test, Harkin said that Almac is working with “dozens” of centers to generate the data needed for a 510(k) submission. Partners include Massachusetts General Hospital, the University of Calgary, the Karolinska Institute, Queen’s University Belfast, Georgetown University, and St. Vincent’s Hospital in Dublin. Almac announced a collaboration with MGH to screen colorectal polyp tissue samples last April.

Ultimately the colorectal cancer recurrence test will be validated by a “major cooperative group” in the US, Harkin said. “We have an approval path agreed with the FDA, and we would hope to have that test launched by the end of 2009,” he said.

Almac’s lung cancer test is designed to identify patients with early stage, non-small-cell cancer. Harkin said that there are “over 200,000 patients diagnosed” with this kind of lung cancer worldwide each year, so he believes that a test for early identification will play in a “sizeable market.” Almac is working with 10 international centers, including Queen’s University Belfast, the University of Turin, and MD Anderson Cancer Center. “Based on our time lines for [the] colorectal [test], we think this test will be ready for commercialization in early 2010,” said Harkin.

Finally, Harkin said that it is in the process of designing a two-phase study for developing and validating its DCIS test. He suggested that the test could become available by late 2010. In addition to the tests for colorectal cancer, lung cancer, and DCIS, Almac also is at work on a test for prostate cancer, Harkin said.

According to Harkin, Almac does not intend to commercialize its first tests alone. Instead, he said the firm is in “advanced negotiations with a couple of large diagnostics companies” to license the stage 2 colorectal cancer recurrence test.

“We see ourselves as the innovator and solution provider because we have technology, but we want to be absolutely sure that we have a clear route to commercialization,” he said. “We see ourselves as a company providing a pipeline of diagnostics to partners.”

Companion Diagnostics

Almac Diagnostic Services is a division of the Almac Group, a 2,000-employee drug development services company with offices in the UK and the US. Almac Diagnostic Services employs around 100 people, 75 of whom are in Northern Ireland and the other 25 in Durham, NC. Harkin said that Almac sees the Durham facility as a launching point for marketing its tests to another group of clients — pharmaceutical and biotech companies.

This is where the lengthy contract with Affymetrix will come in handy for Almac, which needs to show its potential customers that it can provide chips over an extended period of time.

“We work with partners in those industries to provide companion diagnostics, and we wanted a mixture so we could cover broadly all type of cancer types,” Harkin said. The agreement with Affy “confirms our supply of those arrays for the long term, which allows us to provide DSAs to our partners in the long term as well,” he said. “It is this kind of commercial agreement that ensures that we have access to the technology and so do our partners.”

Harkin declined to name Almac’s pharma and biotech clients. He said that they are mostly using Almac’s chips for discovery work as well as biomarker validation. Harkin added that these firms are using Almac’s DSAs to stratify sample populations during clinical trials.

According to Harkin, Almac’s ability to work with FFPE samples as well as fresh frozen samples has made it an attractive partner for pharmas and biotech. FFPE is the “manner in which most clinical samples are stored,” he said. “If you want to design the right kind of validation study, you need access to older materials. The ability to go back and mine data sets from paraffin is quite powerful.”

© Copyright 2008 GenomeWeb Daily News. All rights Reserved.

The post Almac Inks 15-Year Deal with Affy to Secure Rights to Develop and Sell Array-Based Dxs appeared first on Almac.

21 February 2008.  Almac Diagnostic Services today announced the extension and widening of its ‘Powered by Affymetrix™’ (PbA) agreement with Affymetrix Inc. (NASDAQ: AFFX) for an additional 15 years. The new agreement enables Almac to develop diagnostic products utilising Affymetrix’ microarray technology for all cancer areas. Almac has chosen the Affymetrix system as the platform of choice for the development of its proprietary Cancer DSATM product line, the discovery tools behind Almac’s IVD pipeline.

Almac Diagnostic Services will continue to work with the U.S. Food and Drug Administration (FDA) on a 510K-approval route for its first IVD, a stage 2 colorectal cancer recurrence test being developed using the Almac Colorectal Cancer DSATM with an intended launch date in 2009.  Almac is also developing IVDs in stage I lung cancer and DCIS utilizing its Lung and Breast Cancer DSATM products respectively.

“The extended PBA agreement with Affymetrix will facilitate the expansion of the Almac IVD pipeline and that of its partners to include additional prognostic and predictive tests in all cancer types. Our DSATM technology when applied to formalin fixed paraffin embedded (FFPE) tissue facilitates a rapid transition from discovery to validation, dramatically reducing the timelines for test development,” said Prof. Paul Harkin, President & Managing Director, Almac Diagnostic Services.

“The Cancer DSATM product line also provides an exciting new solution for our partners in pharmaceutical, biotech and academic organizations, enabling the reduction of discovery timelines, acceleration of the validation process and ultimately the delivery of clinical applications.” added Prof. Harkin.

“We are pleased to expand our relationship with Almac Diagnostic Services. Almac is a leader in the diagnostic field and this decision further affirms the Affymetrix system as the platform of choice for molecular diagnostic applications,” said Greg Yap, Vice President of Strategic and Commercial Development, Molecular Diagnostics at Affymetrix. “Molecular based signature assays like these will change the paradigm for future patient care and treatment by providing clinicians with a more efficient method to diagnose, classify and manage various types of cancer.”

Affymetrix is partnering with the world’s leading diagnostic companies through the

Powered by Affymetrix™ program to bring about new diagnostic tests that can provide more efficient and complete methods to diagnose, classify and manage complex diseases like cancer. The Affymetrix GCS3000Dx is the only microarray instrumentation platform to receive regulatory clearance by the U.S. FDA and to be CE marked in the European Union for in-vitro diagnostic use. There are currently more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its 10 PbA Partners.

Notes to Editor

About Almac Cancer DSATM Research Tools

The Cancer DSATM research tools are the first high density transcriptome based microarrays which focus on the transcriptome of a particular disease. These contain the most complete transcriptome information available for the disease under investigation, on a single array.

The DSATM technology has been optimised to work with both fresh frozen and formalin fixed paraffin embedded (FFPE) samples, allowing access to the vast amount of information currently available in tissue banks and enabling retrospective discovery and validation studies.

About Almac Diagnostic Services

Almac Diagnostic Services provides translational genomic based solutions for Pharma, biotech and academic customers. Almac specialises in working with fresh and formalin fixed paraffin embedded (FFPE) tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including world leaders in the pharmaceutical and biotech sectors. The company has 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit almacgroup.com.

About Affymetrix

Affymetrix GeneChip® microarray technology is the industry-standard tool for analyzing complex genetic information. After inventing microarray technology in the late 1980s, Affymetrix scientists have been dedicated to developing innovative products that provide researchers with a more complete view of the genome. These products continue to accelerate genetic research and enable scientists to develop diagnostics and tailor treatments for individual patients by identifying and measuring the genetic information associated with complex diseases.

Today, Affymetrix technology is used by the world’s top pharmaceutical, diagnostic and biotechnology companies, as well as leading academic, government and not-for-profit research institutes. More than 1,700 systems have been shipped around the world and more than 11,000 peer-reviewed papers have been published using the technology.

Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., Cleveland, Ohio and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit: www.affymetrix.com.

Forward-looking Statements

All statements in this press release that are not historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix’ “expectations,” “beliefs,” “hopes,” “intentions,” “strategies” or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to: risks and uncertainties relating to commercial success of the agreement with Almac Diagnostic Services discussed in this press release; risks of the company’s ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses; uncertainties related to technological approaches, manufacturing and product development; personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties related to sole-source suppliers; risks associated with past and future acquisitions; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix’ Form 10-K for the year ended December 31, 2006, and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Affymetrix’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

NOTE: Affymetrix, the Affymetrix logo and GeneChip® are registered trademarks owned or used by Affymetrix Inc.

Contact: Michael Sloan

T: + 44 (0)28 3833 7575

E: diagnostics@almacgroup.com W: almacgroup.com

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An independent panel of judges was assembled by IBC Conferences to evaluate the new technologies presented based on their functionality and application. Almac Diagnostic Services will now be invited to give a podium presentation during the 2008 ‘Discovery 2 Diagnostics’.

Professor Paul Harkin, President & Managing Director of Almac Diagnostic Services said: “Among other things, our work on microarrays will ensure an increasingly effective cancer research process. At Almac, we are committed to the delivery of superior solutions for the advancement of human health solutions and this award recognises our world-leading work in this field.”

Kevin Ellison, Almac Diagnostic Services Business Development Manager said: “We are extremely pleased to have won this award which recognises our Cancer DSA™ as the premier micorarray platform for cancer research. We look forward to presenting full details of our work on microarrays at the conference next year”

Ends

Contact

Notes to editors

Cancer DSA™ Technology

Almac Diagnostic’s range of Cancer DSA™ research tools are novel microarrays developed to enable accelerated research in discovery, development and validation and ultimately to deliver clinical applications.

As the first microarrays based around the transcriptome of an individual disease, this technology generates significantly more information, which is reliable and relevant to the disease of interest, than is available on a generic array.

Cancer DSA™ research tools are designed to work with both fresh frozen and paraffin embedded tissue, allowing application of this unique microarray technology to current clinical practice and retrospective tissue banks.

Array content has been generated through a process of high throughput sequencing of the chosen tissue and disease, followed by extensive bioinformatics analysis to create and annotate the unique, comprehensive coverage of disease and tissue specific transcriptomes. This provides researchers with all the information required to draw meaningful conclusions from their experimental data.

Based upon the gold standard Affymetrix GeneChip® technology, the Cancer DSA™ research tools provide multiple independent measurements for each transcript and content is both reliable and reproducible.

The Breast Cancer DSA™ research tool contains ~60,000 probesets

o 41% transcripts are present in the human RefSeq database

o 51% of transcripts are not present in the human RefSeq database

o 8% of the content represents expressed antisense transcripts to annotated genes

To date, Almac Diagnostic Services has launched Colorectal Cancer DSA™ and Breast Cancer DSA™ and Lung Cancer DSA™. Ovarian Cancer DSA™ and Prostate Cancer DSA™ will be launched in 2008. A pipeline of tests and applications of DSA™ research tools in other disease areas is under development.

About Almac Diagnostic Services

Almac Diagnostic Services is the only global genomic services provider with the capability to deliver fully translational genomics research, from early discovery projects, through to clinical validation and regulatory approval.

Through laboratories in US and Europe, pharma and biotech companies partner with Almac to harness the power of genomics for diagnostic and prognostic development, drug development and patient selection, target identification and companion diagnostics projects.

Customers also utilise Almac’s special expertise in cancer genomics and the extraction of robust and reproducible transcript information from FFPE tissue.

Almac’s leadership in these areas was demonstrated in April 2007 when the company agreed a 510k approach with FDA for the first gene signature multi-variate IVD to be generated from FFPE tissue.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The post Almac wins top award at Tech Idol Showcase appeared first on Almac.

The Journal of the National Cancer Institutes has published results of a collaboration between Queens University, Belfast and Almac Diagnostic Services using the company’s Breast Cancer Disease Specific Array™, to generate valuable new insight into the interactions between BRCA1 and estrogen receptor alpha (ERα).

It has been widely reported in the literature that BRCA1 linked breast cancers typically fail to express ERα, however the mechanism behind this link has remained obscure.  ERα is the therapeutic target for antiestrogen therapies such as fulvestrant and tamoxifen, while BRCA1, a tumour suppressor gene, is associated with genetic predisposition to breast and ovarian cancers.

The Queens / Almac study has demonstrated that BRCA1 alters the response of breast cancer cells to fulvestrant therapy by directly modulating ERα mRNA expression.

“The initial clue that BRCA1 may directly regulate ERα at the mRNA level came from expression profiling studies utilizing the Almac Diagnostic Services Breast Cancer DSATM directly from Formalin Fixed Paraffin Embedded (FFPE) tumour samples,” said Prof Paul Harkin.

The array data demonstrated that ERα mRNA expression was 5.4-fold lower in tumors with BRCA1 mutations than in sporadic tumors and was subsequently confirmed by real time PCR.  The study went on to demonstrate that BRCA1 directly regulates ESR1 expression through an Oct-1 dependent interaction with the ESR1 promoter.  Finally it was shown that expression of ERα in BRCA1-depleted breast cancer cells made the cells more sensitive to an antiestrogen drug Fulvestrant.  They conclude that BRCA1 alters the response of breast cancer cells to antiestrogen therapy by directly influencing ERα expression.

For further information, please contact Kerry Kennedy,

Tel. +44 2838 337575, email: kerry.kennedy@almacgroup.com or visit almacgroup.com/diagnostics

The post BRCA1 Mutations Influence Cancer Cells’ Response to Drugs appeared first on Almac.

08 Aug 2007.  Almac Diagnostic Services announced a major study analysing ductal carcinoma in situ tissue samples using its novel Breast Cancer DSA™ microarray.  DSA™ research tools focus on the transcriptome of an individual disease, in this case breast cancer, and contain significant additional data, relevant to the disease of interest that is not available on other generic microarrays.  The study will be conducted in collaboration with Prof Adrian Harris, Cancer Research UK and Professor of Medical Oncology at the University of Oxford.

“Our novel technology is helping researchers to reduce discovery timelines, accelerate the validation process and ultimately deliver clinical applications in this disease setting.” said Paul Harkin, BSc, PhD, Professor of Molecular Oncology at the Center for Cancer Research and Cell Biology, Queen’s University, Belfast and MD and President of Almac Diagnostic Services.

“This particular study aims to generate a gene signature to identify the subset of DCIS patients who are likely to suffer a recurrence,” he added.

The study will use paraffin embedded samples and is due to commence in the coming weeks.  Tissue samples will be analysed using the Breast Cancer DSA™ research tool.  An Almac bioinformatics team will interrogate the resulting data to identify any potential signature.

“Our research will use the Breast Cancer DSA™ microarray to examine the transcriptome of ductal carcinoma in situ at a greater level of specificity generating additional information that will help us draw meaningful conclusions from our data.  Eventually we hope to develop a gene expression signature that will inform clinical treatment strategies” said Prof Adrian Harris, Cancer Research UK Professor of Medical Oncology at the University of Oxford and Principal Investigator on the study.

In most cases, the treatment for DCIS is total mastectomy as it is curative in nearly all patients1.  However, this strategy may represent over-treatment for those patients in whom disease will not recur2.  A gene signature identifying the subset of DCIS patients most likely to suffer a DCIS recurrence, could therefore be used to aid those remaining patients who have been identified as unlikely to suffer a recurrence to choose to undergo breast conserving surgery.

ENDS

1: Stuart K, Boyages J, Brennan M, Ung O. Ductal Carcinoma In Situ – management update. Aust Fam Physician. 2005 Nov; 34(11):949-54.

2: Baxter NN, Virnig BA, Durham SB, Tuttle TM. Trends in the treatment of ductal carcinoma in situ of the breast. J Natl Cancer Inst. 2004 Mar 17; 96(6):443-8.

The post Almac Diagnostic Services Announces Pioneering Genetic Research on Ductal Carcinoma In Situ (DCIS) Using Breast Cancer DSA™ Research Tool appeared first on Almac.

Based on the meeting, Almac Diagnostic Services plans to accelerate the development and clearance of its In Vitro Diagnostic (IVD) utilizing the 510(k) approach to regulatory submission. The company will now finalize the design of analytical and clinical studies required for US marketing clearance. While there can be no assurance that FDA will ultimately clear the product through the 510(k) premarket notification process, the company has decided to pursue that route of market clearance based on the preliminary discussions with the agency.

The prognostic gene signature was developed entirely from FFPE samples. Designed to help clinicians determine the risk of cancer recurrence in patients diagnosed with stage II CRC, the proposed IVD will be run on a customized microarray. CRC is the second most frequent malignancy in Western societies1.

Almac Diagnostic Services, a division of the Almac Group, aims to be a global leader in the provision of genomic based solutions for the advancement of patient care. In addition to its own DSA™ technology, the company provides an all-inclusive accredited micro arraybased profiling service along with bioinformatics support to academia, biotech and pharmaceutical companies.

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including world leaders in the pharmaceutical and biotech sectors. The company is headquartered in

Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

Website: almacgroup.com/diagnostics

For further information, please contact:

Almac Diagnostic Services

Joanne McGowan

+44 (0) 283 839 5982

joanne.mcgowan@almacgroup.com

Edelman

Liz Panos

+44 (0) 207 344 1304

elizabeth.panos@edelman.com

1 World Health Organization, WORLD CANCER REPORT 2003, International Agency for

Research on Cancer, Edited by Bernard W. Stewart and Paul Kleihues.

The post Almac Diagnostic Services Attends Pre-ide Meeting With FDA for Colorectal Cancer Diagnostic Derived from FFPE Tissue Craigavon, Northern Ireland, 28 May 2007 appeared first on Almac.

Almac Diagnostic Services today announced a major study analysing colorectal polyp tissue samples using its novel Colorectal Cancer DSA™ microarray. The DSA™ research tool focuses on the transcriptome of an individual disease, in this case colorectal cancer, and contains significant additional data, relevant to the disease of interest that is not available on other generic microarrays. The study will be conducted in collaboration with leading genetic researchers at Massachusetts General Hospital (MGH) (in the US.)

“Our novel technology has been developed to help researchers reduce discovery timelines, accelerate the validation process and ultimately deliver clinical applications in this disease setting. For researchers, our technology provides a comprehensive, long term, stable research platform,” said Paul Harkin, BSc, PhD, Professor of Molecular Oncology at the Center for Cancer Research and Cell Biology, Queen’s University, Belfast and MD and President of Almac Diagnostic Services.

“Down the line, this particular study aims to more accurately determine the likelihood of colorectal polyps becoming cancer. Using our proprietary technology and MGH’s expertise, we have a strong foundation for developing predictive signatures that can benefit patients,” he added.

The study will use paraffin embedded samples and collection is currently underway. Tissue samples will be analysed by Almac Diagnostic Services over two years. Information derived from the study will be analysed by a joint Almac and MGH informatics team.

“Our research will use the DSA™ microarray to examine the transcriptome of colorectal polyps at a greater level of specificity and to generate information that will help us draw meaningful conclusions from our data. Eventually we hope to develop a gene expression signature that will inform both surveillance and preventative protocols for colorectal cancer,” said Sridhar Ramaswamy, MD, [Tucker Gosnell Investigator & Assistant Professor of Medicine, Massachusetts General Hospital Cancer Center and a Principal Investigator on the study].

DSA™ Technology

Almac Diagnostic’s range of Cancer DSA™ research tools are novel microarrays developed to enable accelerated research in discovery, development and validation and ultimately to deliver clinical applications.

As the first microarrays based around the transcriptome of an individual disease, this technology generates significantly more information, which is reliable and relevant to the disease of interest, than is available on a generic array.

Array content has been generated through a process of hi throughput sequencing sequencing of the chosen tissue and disease, followed by extensive bioinformatics analysis to create and annotate the unique, comprehensive coverage of disease and tissue specific transcriptomes. This provides researchers with all the information required to draw meaningful conclusions from their experimental data.

Based upon the gold standard Affymetrix GeneChip® technology, the DSA™ research tools provide multiple independent measurements for each transcript and content is both reliable and reproducible.

The Colorectal Cancer DSA™ research tool contains 61,528 probesets covering 52,306 colorectal expressed transcripts:

o 21,968 (42%) are present in the human RefSeq database

o 26,676 (51%) of transcripts are not present in the human RefSeq database

o 7% of the content represents expressed antisense transcripts to annotated genes

To date, Almac Diagnostic Services has launched Colorectal Cancer DSA™ and Breast Cancer DSA™. Lung Cancer DSA™ will be launched in June, and Ovarian Cancer DSA™ and Prostate Cancer DSA™ will be launched later this year. A pipeline of tests and applications of DSA™ research tools in other disease areas is under development.

Clinical Application of the Colorectal Cancer DSA™ research tool

The successful clinical application of the Colorectal Cancer DSA™ research tool was first demonstrated in colorectal cancer as a prognostic signature in stage II colorectal cancer to identify patients at high risk of relapse post surgery. Results from this study were presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2006.

Application of this technology provides clinically relevant data that may ultimately improve patient care in a wide range of contexts including companion diagnostics, biomarker discovery and patient stratification.

The Vital Role of Research on Colorectal Pre-Malignancies

Colorectal cancer is the second most frequent malignancy in affluent societies. More than 940,000 cases occur annually worldwide and nearly 500,000 die from the disease each year. Most colorectal cancers begin as polyps or adenomas, growths attached to the inside of the colon or rectum. Colorectal polyps commonly occur, but most of them do not turn into cancer.

US protocols advise screening for colorectal polyps at age 50 years, with followup surveillance anywhere from two years to ten years afterwards, while the NHS Bowel Cancer Screening Programme offers screening every two years to all men and women aged 60 to 69. The aim is to detect bowel cancer at an early stage, when treatment is more likely to be effective. However, these screening programmes represent a significant burden to both patients and healthcare systems. In addition, even with intensive surveillance programmes, there is still the possibility that colorectal cancer can go undetected.

About Almac Diagnostic Services

Almac Diagnostic Services, a division of the Almac Group develops and delivers novel genomic research products to enable research innovation and accelerate the drug discovery pipeline from validation to market.

Using their proprietary Cancer DSA™ research tools, Almac Diagnostic Services develops clinical tests to improve the diagnosis and treatment of cancer patients.

The company also provides an all-inclusive accredited micro-array-based profiling service along with bioinformatics support to academia, biotech and pharmaceutical companies, as well as access to its own unique technology.

Almac Diagnostic Services aims to be a global leader in the provision of genomic based solutions for the advancement of patient care.

About the Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

ENDS

For further information, please contact Elizabeth Panos, Edelman Public Relations:

Tel. +44 20 7344 1328, email: elizabeth.panos@edelman.com,

or visit almacgroup.com

diagnostics@almacgroup.com

The post Almac Diagnostic Services Announces Pioneering Genetic Research appeared first on Almac.

Almac Diagnostic Services, a division of Almac Group, and GeneGo, Inc., a leading provider of software, databases and services for systems biology, announced today that Almac Diagnostic Services has licensed the flagship datamining suite, MetaCore.

The multiple-year agreement will allow Almac Diagnostic Services’ scientists in the UK and US to use MetaCore in the development of novel microarray-based products for the diagnosis and treatment of cancer. Almac Diagnostic Services’ Genomic Services division who deliver comprehensive genomic services to academic, biotech and pharmaceutical customers will also use Metacore.

Almac values the completeness and quality of content coverage in MetaCore from signaling ligands to core metabolic pathways, its intuitive interface and comprehensive automated analysis workflows.

“We compared several platforms before we finally decided on GeneGo. MetaCore has broad and deep, high quality content coverage, which was important to us. Furthermore its ability to work with mixed ID’s is critical for our internal R&D work and service offerings based on our unique DSATM (patent pending) research tools” said Dr Vitali Proutski, Bioinformatics Manager at Almac Diagnostic Services. “We were also very impressed by GeneGo’s responsiveness and strong customer support which we feel is vital in relationships with our partners.”

“We are very pleased to welcome Almac Diagnostic Services as a new GeneGo customer. Our experience with them during the thorough evaluation was very positive, with constant communication between Almac Diagnostic Services and GeneGo scientists” said Julie Bryant, Vice President of Business Development at GeneGo. “Our products are gaining momentum in clinical diagnostics, both on the development side and among practitioners. Almac combines both as a highly reputable, scientific oriented new generation CRO.”

About Almac Diagnostic Services

Almac Diagnostic Services – a division of the Almac Group– develops, markets and supplies, leading edge genomic products and services.

Almac Diagnostic Services has two divisions:

The Genomic Services division provides all inclusive gene expression, SNP and bioinformatics services to academia, biotech and pharmaceutical companies. These services include analysis on our unique Disease Specific Array™ research tools, which provide the ability to detect the maximum information in a given cancer type. Almac Diagnostic Services is the first Authorised Affymetrix Service Provider to successfully gain accreditation to ISO17025 for our comprehensive Gene Expression Microarray and Bioinformatics services.

The Research & Development Division develops, using proprietary DSATM research tools, new tests that will change the way cancers are managed in the future. These proprietary arrays provide unique information for individual cancer types and represent a stable, long-term platform for the development of clinical diagnostics.

almacgroup.com

About GeneGo

GeneGo develops systems biology technology for life science research. The original computational platform allows an integration and expert analysis of different kinds of experimental data (mRNA expression, proteomics, metabolomics, siRNA and other phenotypic data) and relevant bioactive chemistry (metabolites, drugs, other xenobiotics) within the framework of curated biological pathways and networks.

GeneGo’s flagship product, MetaCore 4.1, assists pharmaceutical scientists in the areas of target selection and validation, identification of biomarkers for disease states and toxicology. The second product, MetaDrugTM is designed for prediction of human metabolism, toxicity and biological effects for novel small molecules compounds. MetaBaseTM represents the knowledge base for MetaCore.

For more information, please visit the company’s web site at www.genego.com MetaCore™, MetaBaseTM and MetaDrugTM are trademarks of GeneGo, Inc.

Contact: Julie Bryant

VP Business Development and Marketing

GeneGo, Inc.

(858) 756 7996

julie@genego.com

diagnostics@almacgroup.com

+44(0)28 3833 7575

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EIRX THERAPEUTICS PLC

(“EiRx” or “The Company”)

EiRx and Almac Diagnostic Services Sign Joint Euro400K Colorectal Cancer Agreement

Cork, Ireland, 9th March 2006 – EiRx Therapeutics plc (AIM: ERX), the drug discovery company developing targeted therapies initially for the treatment of colorectal cancer, announces that it has signed a collaborative agreement with applied genomics specialists Almac Diagnostic Services Ltd of Craigavon, Northern Ireland. The agreement provides terms for the creation and commercialisation of intellectual property arising from a research alliance between the two companies.

The collaboration is being facilitated in part by the InterTradeIreland INNOVA Collaborative R&D program which will contribute up to Euro400,000 to fund salaries, research expenses, protection of intellectual property, overheads, travel and other allowances over a two year period.

Under this alliance EiRx will use its ALIBI(TM) platform to design and model the transformation events and mechanisms associated with resistance to apoptosis (cell death) that occur in the early development of colorectal cancer. Almac Diagnostic Services will measure and correlate gene expression changes associated with the transformation using gene microarray technology. The molecular function of candidate genes in colorectal cancer cells will then be validated using EiRx’s proprietary siRNA delivery system and in-vitro apoptosis assays. These targets will form the basis for the design of new drugs designed to selectively and specifically induce apoptosis in colorectal cancer cells.

EiRx and Almac Diagnostic Services view the signing of this agreement as the first phase of a strategic alliance that is expected to expand as the two technology-driven companies work together to develop enhanced treatments for colorectal cancer.

Commenting on the collaboration, EiRx COO Colin Telfer said: “We are delighted to sign this collaboration with Almac Diagnostic Services, whose leading expertise in microarray technology combines with EiRx’s skills in functional genomics and translational biology to create a powerful competitive edge. We believe our collaboration will lead to significant advances in understanding of the molecular basis of colorectal cancer and drive our mission to develop new and better medicines.”

For further information, please contact:

EiRx Therapeutics plc

John Pool, Chairman 01260 226529

Buchanan Communications

Tim Anderson / Mark Court / Mary-Jane Johnson 020 7466 5000

Notes for Editors:

About EiRx

EiRx Therapeutics (AIM: ERX) is a research-driven healthcare company developing new-targeted therapies for the treatment of cancer. The company, which is headquartered in Cork, Ireland, conducts drug discovery from its laboratories in Cork and in Aberdeen, Scotland, and has an initial focus on colorectal tumours, currently the number two cause of cancer-related deaths worldwide.

Since its foundation in 1999 EiRx has developed into a leader in the study of functional pathways critical to cancer cell survival and growth, with a research base encompassing apoptosis biology, translational medicine and the metabolic basis of drug resistance in tumours. Using its state-of-the-art, proprietary ALIBI(TM) platform, EiRx has gained new insights into the mechanisms underlying a cell’s decision to survive or die, and has implicated a range of novel genes in pivotal control mechanisms such as the PI3K/AKT and GSK/Wnt survival pathways. In combining functional validation technologies with unique clinical resources such as the ACCRI-BANK tissue collection, EiRx is linking the molecular activity of these targets with clinical consequences in patient populations. By streaming validated targets into an innovative compound screening approach EiRx is creating a product development engine specialising in cancer target discovery, validation and targeted therapy.

The EiRx business strategy is three-fold, and integrates (i) discovery and out-licensing of validated cancer diagnostic and drug targets, (ii) discovery and development of new anticancer drugs through independent or collaborative research, and (iii) application of proprietary knowledge and technologies through collaborative R&D initiatives.

Notable milestones in 2005/6 include:

Acquisition of oncology company Auvation Ltd

Collaborative research agreement with Merck & Co. Inc. to evaluate EiRx’s siRNA delivery technology

Award of a Marie Curie Programme grant from the European Commission, to support development of the company’s screening, chemistry and efficacy testing capabilities

Development of the EnPAD(TM) drug screening technology to enable identification of compounds that specifically target cell survival pathways

Filing of patent applications on first series of potential anti-cancer compounds identified using EnPADTM, which target the b-catenin signalling pathway to selectively kill colorectal and breast cancer cells in vitro

Filing of patent application describing a second series of potential anti-cancer compounds identified using EnPADTM

ALIBITM platform

To identify effective drug targets it is vital to differentiate between genes that are causal and those that are consequential to the biological process under study. EiRx’s ALIBITM drug target discovery platform exploits physiological, disease and process-relevant cellular models to achieve this goal. Practical application of the ALIBITM platform has been validated in a detailed analysis of the apoptotic mechanism, and works as follows. An appropriate cellular disease model is selected and a series of assays designed to focus and steer signalling pathway analysis. The apoptotic mechanism and its counteracting survival pathways are subjected to extensive molecular characterisation (genomic and biochemical) to determine kinetics, functional dependency and the ability of inhibitors and siRNA reagents to modulate the targeted cellular processes. Output data is analysed using a suite of bioinformatics tools, resulting in identification of candidate drug targets whose expression is highly correlated with the apoptosis and survival process across the entire assay panel. The current study will utilize the principals of ALIBITM to model the very early events associated with cellular transformation of colorectal cells, thereby identifying specific molecular components which can be targeted by new colorectal cancer drugs.

For more information visit www.eirx.com

About Almac Diagnostic Services

Almac Diagnostic Services Limited (www.almac-diagnostics.com) is a cancer diagnostics company that was founded in 2003 by Professor Patrick Johnston and Professor Paul Harkin from Queens University Belfast in partnership with the McClay Trust and is based in Craigavon, Northern Ireland. Almac Diagnostic Services Ltd is committed to the development and clinical validation of the next generation of cancer diagnostics products.

Almac Diagnostic Services Ltd believes that its approach of harnessing high throughput enabling technologies combined with state of the art bioinformatic tools to precisely define gene expression changes is essential to the development of the next generation of microarray based cancer diagnostic products. Almac Diagnostic Services is working closely with some of the worlds leading genomics companies to achieve these aims.

Almac Diagnostic Services is part of the Almac group of companies, a privately owned group of affiliated companies comprising four principal divisions, CTS (Clinical Trial Services), CSS (Chemical Synthesis Services), PDMS (Pharmaceutical Developmental and Manufacturing Services and ICTI (Interactive Clinical Technologies Inc). Almac’s headquarters are based in Craigavon, Northern Ireland with facilities in mainland UK and the United States (www.almac-sciences.com) as well. Almac Diagnostic Services has benefited from the extensive networks already established by Almac Sciences in the pharmaceutical industry and aims to spearhead Almac’s expansion into the genomic service market.

For more information visit almacgroup.com

About colorectal cancer

Colorectal cancer is the third most common cancer in both sexes, accounting for between 10 and 15 percent of all cancer diagnoses. Although highly responsive to treatment when detected at an early stage, the prevalence of late-stage diagnoses means it is second only to lung cancer in the number of cancer deaths it causes. According to the World Health Organisation, almost 950,000 people worldwide were diagnosed with colorectal cancer in 2000 and about half that number died.

The post Eirx Therapeutic Plc & Diagnostic Services Agreement appeared first on Almac.

Almac Diagnostic Services has become the first authorised Affymetrix service provider to gain accreditation to ISO17025 for its comprehensive gene expression microarray and bioinformatics services. Almac Diagnostic Services develops, markets and supplies leading edge genomic expression services together with products, which will radically improve the diagnosis and treatment of cancer.

ISO 17025 is an international quality management standard used to assess the competency of analytical laboratories for the test methodology described in their scope of accreditation. Almac Diagnostic Services’ scope of accreditation applies to microarray and bioinformatics analysis on RNA extracted from biota, tissue and tumour samples utilising the Affymetrix GeneChip® platform.

Professor Paul Harkin of Almac Diagnostic Services said, “We are very proud of this achievement. It demonstrates our company’s commitment to high quality, customer orientated microarray and bioinformatics services to the academic, biotechnology and pharmaceutical sectors.”

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