Almac Diagnostic Services Announces Pioneering Genetic Research

April 16, 2007

Study Being Conducted with Massachusetts General Hospital

Almac Diagnostic Services today announced a major study analyzing 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 analyzed by Almac Diagnostic Services over two years. Information derived from the study will be analyzed 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 Program 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 programs represent a significant burden to both patients and healthcare systems. In addition, even with intensive surveillance programs, 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.


For further information, please contact Elizabeth Panos, Edelman Public Relations:

Tel. +44 20 7344 1328, email: [email protected],

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