Biomarker Laboratory Services


Internal Diagnostics State-of-the-Art Laboratories

Our high-tech laboratories are fully equipped with a choice of genomic and genetic platforms appropriate for companion diagnostic develop and are ready to operate both research-use-only and clinical diagnostic assays. We have fully automated processing in place and a full laboratory information management system, which tracks samples from receipt to the completion of your study. You can make use of any of these services in a fee-for-service manner for routine genomic research.

Supporting Services

Partnering with us you’ll have access to extensive bioinformatics support, from study design through to data interpretation. We also offer a range of supporting services, from sample sourcing and tissue processing to immune histochemistry and pathology review.


More Details

RNA Analysis
DNA Analysis
Bioinformatics Services
Supporting Services
Xcel Array™ and Cancer DSA®
Quality Assurance

RNA Analysis

Over Ten Years’ Experience Working with RNA Profiling

We bring extensive experience to the table, having processed tens of thousands of samples for gene expression analysis.

Our specific area of expertise is working with degraded RNA from FFPE samples. This difficult sample type is used routinely in our labs for both biomarker discovery and routine clinical testing. Our research and diagnostic systems handle a range of complexity and processing rates, from low to extremely high.

Through our expertise we’ve developed our own range of biomarker discovery tools: – the Xcel and Cancer DSA arrays, which are microarray-based tools optimized for biomarker research in FFPE tissue. We have used these tools extensively for both biomarker discovery and development and in the delivery of clinical assays in routine testing.

  • Affymetrix RUO & DX V2 Genechip® Systems
  • Roche LightCycler®
  • Life Technologies QuantStudio™
  • Illumina MiSeq®
  • Cancer DSA® Microarrays
  • XCEL™ Microarray
  • Fluidigm BioMark™ HD
  • Sanger Sequencing
  • Affymetrix SNP 6.0, DMETTM, OncoScan®

DNA Analysis

From Traditional Sanger Sequencing to Next Generation Sequencing

We offer qPCR services for DNA analysis and array-based systems such as the Affymetrix DMETTM, Oncoscan®, Cytoscan® and routine SNP arrays.
All of our DNA analysis services can be utilised in both a research and a diagnostics manner. The platforms we use for DNA analysis are suitable for diagnostic delivery and we have a number of CLIA validated assays available, such as the Cobas® KRAS, BRAF and EGFR.

We have also developed our own CLIA validated next generation sequencing assay for the P53 oncogene. This test has been developed in collaboration with Illumina® and is delivered on the MiSeq platform from our CLIA/CAP lab.

  • Affymetrix RUO & DX V2 Genechip® Systems
  • Roche LightCycler®
  • Life Technologies QuantStudio™
  • Illumina MiSeq®
  • Cancer DSA® Microarrays
  • XCEL™ Microarray
  • Fluidigm BioMark™ HD
  • Sanger Sequencing
  • Affymetrix SNP 6.0, DMETTM, OncoScan®

 


Bioinformatics Services

Fully Supporting the Discovery, Development and Delivery of Biomarkers

Our expert bioinformatics and biostatistics team will partner with you throughout your study, providing efficient, customised and innovative solutions. We offer complete transparency throughout, with all methodology, programs and analytical methods available for result verification.

Our Services

  • Study design
  • Sample processing and data generation
  • Quality control
  • Exploratory analysis
  • Signature generation
  • Functional analysis
  • Sub-types discovery

We employ highly qualified and experienced scientists within our bioinformatics and biostatistics team. Our PhD level scientists have substantial experience in molecular and cell biology, drug discovery and development, and diagnostic product development. To support them, we have a highly complex technology infrastructure designed to handle large data sets quickly and securely.

Standard Software Platforms

We utilize industry standard software platforms including:

  • Matlab®
  • SAS®
  • Partek® Genomics Suite™
  • Ingenuity Pathway Analysis®

Bespoke Solutions

Recognising that our customers’ needs are unique , we have also developed numerous bespoke solutions and workflows. These solutions range from novel scripts and analysis pipelines to fully developed in-house software packages. Our innovative tools are implemented at all stages of the analysis pipeline and form an integral part of the solutions we offer.

View Almac’s webinar ‘An Integrated Approach to Biomarker Discovery’


Supporting Services

Helping You Achieve Your Goals

Sample Sourcing
Should your study require clinical samples to support both analytical and clinical validation. We offer sample sourcing as a seamless component of our overall service.

Pathology
From simple H&E staining and path review to IHC scoring development services, our team of pathologists are on-hand to support you from discovery to clinical testing.

Tissue Fixation
The majority of tests we develop and deliver are carried out on FFPE material. When a mixture of fresh tissue and FFPE is to be used, we also offer tissue processing and fixation services to enable standardised testing.

Microtomy and Macrodissection
We can ensure your samples meet test specifications, working with FFPE blocks and sections, cutting as required and macro-dissecting these sections.

IHC/ISH, FISH and ELISA
In addition to more complex genomic technologies, we offer assay development and processing services, using routine immune histochemistry, in-situ hybridisation and ELISA assays.


Xcel Array™ and Cancer DSA®

At Almac we have developed a range of microarrays to provide the optimal platform for biomarker discovery and development across multiple disease areas as well as within specific disease areas. These arrays are high density transcriptome based microarrays based on the gold standard Affymetrix GeneChip® platform.

The two main product lines are Xcel™ array discovery platform for studies in multiple disease areas and Cancer DSA® arrays, for studies within specific disease areas.

All the arrays have been designed using a combination of large-scale in-house sequencing projects, gene expression studies and carefully curated public databases. The arrays are optimised for use with both fresh frozen and formalin fixed paraffin embedded (FFPE) samples which aids in the discovery of clinically relevant biomarkers

Almac Xcel ArrayXcel™ Array

The Xcel™ array is the optimal platform for biomarker discovery that enables the identification of biomarkers within multiple disease areas.

Xcel™ 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 Xcel™ array contains 97,000 transcripts; significantly more than is available on any other platform and the technology is optimised for use with Formalin Fixed Paraffin Embedded (FFPE) tissue.

Almac Cancer DSACancer DSA®

Our Cancer DSA® research tools are the first high-density microarrays which focus on the transcriptome of an individual disease. They contain the most comprehensive information available for the disease under investigation on a single array and enable you to obtain robust data from FFPE and frozen samples, while delivering additional information on the disease setting.

Each Cancer DSA® research tool is designed around an individual disease and tissue specific transcriptome; and as a result contains significant, additional and relevant information.

The portfolio of Cancer DSA® arrays:

  • Breast Cancer DSA®
  • Colorectal Cancer DSA®
  • Ovarian Cancer DSA®
  • Lung Cancer DSA®
  • Prostate Cancer DSA®

Quality Assurance

Almac Diagnostics is accredited by:

• UKAS to ISO17025 (accreditation number 2740)
• CLIA
• College of American Pathologists (CAP)
• New York State (CLEP Permit)
• Almac also holds individual US State licenses for Florida, California and Pennsylvania

Almac Diagnostics holds ISO13485 certification (SGS) and also complies with GLP, GCP and GCLP.




More Details

RNA Analysis
DNA Analysis
Bioinformatics Services
Supporting Services
Xcel Array™ and Cancer DSA®
Quality Assurance

RNA Analysis

Over Ten Years’ Experience Working with RNA Profiling

We bring extensive experience to the table, having processed tens of thousands of samples for gene expression analysis.

Our specific area of expertise is working with degraded RNA from FFPE samples. This difficult sample type is used routinely in our labs for both biomarker discovery and routine clinical testing. Our research and diagnostic systems handle a range of complexity and processing rates, from low to extremely high.

Through our expertise we’ve developed our own range of biomarker discovery tools: – the Xcel and Cancer DSA arrays, which are microarray-based tools optimized for biomarker research in FFPE tissue. We have used these tools extensively for both biomarker discovery and development and in the delivery of clinical assays in routine testing.

  • Affymetrix RUO & DX V2 Genechip® Systems
  • Roche LightCycler®
  • Life Technologies QuantStudio™
  • Illumina MiSeq®
  • Cancer DSA® Microarrays
  • XCEL™ Microarray
  • Fluidigm BioMark™ HD
  • Sanger Sequencing
  • Affymetrix SNP 6.0, DMETTM, OncoScan®

DNA Analysis

From Traditional Sanger Sequencing to Next Generation Sequencing

We offer qPCR services for DNA analysis and array-based systems such as the Affymetrix DMETTM, Oncoscan®, Cytoscan® and routine SNP arrays.
All of our DNA analysis services can be utilised in both a research and a diagnostics manner. The platforms we use for DNA analysis are suitable for diagnostic delivery and we have a number of CLIA validated assays available, such as the Cobas® KRAS, BRAF and EGFR.

We have also developed our own CLIA validated next generation sequencing assay for the P53 oncogene. This test has been developed in collaboration with Illumina® and is delivered on the MiSeq platform from our CLIA/CAP lab.

  • Affymetrix RUO & DX V2 Genechip® Systems
  • Roche LightCycler®
  • Life Technologies QuantStudio™
  • Illumina MiSeq®
  • Cancer DSA® Microarrays
  • XCEL™ Microarray
  • Fluidigm BioMark™ HD
  • Sanger Sequencing
  • Affymetrix SNP 6.0, DMETTM, OncoScan®

 


Bioinformatics Services

Fully Supporting the Discovery, Development and Delivery of Biomarkers

Our expert bioinformatics and biostatistics team will partner with you throughout your study, providing efficient, customised and innovative solutions. We offer complete transparency throughout, with all methodology, programs and analytical methods available for result verification.

Our Services

  • Study design
  • Sample processing and data generation
  • Quality control
  • Exploratory analysis
  • Signature generation
  • Functional analysis
  • Sub-types discovery

We employ highly qualified and experienced scientists within our bioinformatics and biostatistics team. Our PhD level scientists have substantial experience in molecular and cell biology, drug discovery and development, and diagnostic product development. To support them, we have a highly complex technology infrastructure designed to handle large data sets quickly and securely.

Standard Software Platforms

We utilize industry standard software platforms including:

  • Matlab®
  • SAS®
  • Partek® Genomics Suite™
  • Ingenuity Pathway Analysis®

Bespoke Solutions

Recognising that our customers’ needs are unique , we have also developed numerous bespoke solutions and workflows. These solutions range from novel scripts and analysis pipelines to fully developed in-house software packages. Our innovative tools are implemented at all stages of the analysis pipeline and form an integral part of the solutions we offer.

View Almac’s webinar ‘An Integrated Approach to Biomarker Discovery’


Supporting Services

Helping You Achieve Your Goals

Sample Sourcing
Should your study require clinical samples to support both analytical and clinical validation. We offer sample sourcing as a seamless component of our overall service.

Pathology
From simple H&E staining and path review to IHC scoring development services, our team of pathologists are on-hand to support you from discovery to clinical testing.

Tissue Fixation
The majority of tests we develop and deliver are carried out on FFPE material. When a mixture of fresh tissue and FFPE is to be used, we also offer tissue processing and fixation services to enable standardised testing.

Microtomy and Macrodissection
We can ensure your samples meet test specifications, working with FFPE blocks and sections, cutting as required and macro-dissecting these sections.

IHC/ISH, FISH and ELISA
In addition to more complex genomic technologies, we offer assay development and processing services, using routine immune histochemistry, in-situ hybridisation and ELISA assays.


Xcel Array™ and Cancer DSA®

At Almac we have developed a range of microarrays to provide the optimal platform for biomarker discovery and development across multiple disease areas as well as within specific disease areas. These arrays are high density transcriptome based microarrays based on the gold standard Affymetrix GeneChip® platform.

The two main product lines are Xcel™ array discovery platform for studies in multiple disease areas and Cancer DSA® arrays, for studies within specific disease areas.

All the arrays have been designed using a combination of large-scale in-house sequencing projects, gene expression studies and carefully curated public databases. The arrays are optimised for use with both fresh frozen and formalin fixed paraffin embedded (FFPE) samples which aids in the discovery of clinically relevant biomarkers

Almac Xcel ArrayXcel™ Array

The Xcel™ array is the optimal platform for biomarker discovery that enables the identification of biomarkers within multiple disease areas.

Xcel™ 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 Xcel™ array contains 97,000 transcripts; significantly more than is available on any other platform and the technology is optimised for use with Formalin Fixed Paraffin Embedded (FFPE) tissue.

Almac Cancer DSACancer DSA®

Our Cancer DSA® research tools are the first high-density microarrays which focus on the transcriptome of an individual disease. They contain the most comprehensive information available for the disease under investigation on a single array and enable you to obtain robust data from FFPE and frozen samples, while delivering additional information on the disease setting.

Each Cancer DSA® research tool is designed around an individual disease and tissue specific transcriptome; and as a result contains significant, additional and relevant information.

The portfolio of Cancer DSA® arrays:

  • Breast Cancer DSA®
  • Colorectal Cancer DSA®
  • Ovarian Cancer DSA®
  • Lung Cancer DSA®
  • Prostate Cancer DSA®

Quality Assurance

Almac Diagnostics is accredited by:

• UKAS to ISO17025 (accreditation number 2740)
• CLIA
• College of American Pathologists (CAP)
• New York State (CLEP Permit)
• Almac also holds individual US State licenses for Florida, California and Pennsylvania

Almac Diagnostics holds ISO13485 certification (SGS) and also complies with GLP, GCP and GCLP.