Public Release: 

Almac Diagnostics announces pioneering genetic research on ductal carcinoma in situ

Study being conducted with Professor Adrian Harris

Edelman Public Relations

CRAIGAVON, NORTHERN IRELAND, 8 Aug 2007 - Today Almac Diagnostics 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 Centre for Cancer Research and Cell Biology, Queen's University, Belfast and MD and President of Almac Diagnostics.

"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 some 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.

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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.

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 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 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 covering ~60,000 breast expressed transcripts:

  • 41% are present in the human RefSeq database

  • 51% of transcripts are not present in the human RefSeq database

  • 8% of the content represents expressed antisense transcripts to annotated genes

To date, Almac Diagnostics has launched Colorectal Cancer DSA™ and Breast Cancer DSA™ and Lung Cancer DSA™. Ovarian Cancer DSA™ and Prostate Cancer DSA™ will be launched later this year.

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.

Based on a recent meeting with FDA, Almac Diagnostics plans to accelerate the development and clearance of this signature as an 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 clearance1. 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.

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 in Breast Cancer

Breast cancer is the leading cause of gynaecological cancer-related death among women. Worldwide, more than a million women are diagnosed with breast cancer every year, accounting for a tenth of all new cancers and 23% of all female cancer cases2.

The number of registered cases of an early form of breast cancer called Ductal carcinoma in situ (DCIS)3 has increased, according to figures released last year by Cancer Research UK. These show that in 2002 nearly 3800 women in the United Kingdom were diagnosed with DCIS compared with 2910 five years earlier. DCIS occurs when the cells inside the ducts of the breast have started to turn into cancer cells. Some doctors describe DCIS as a very early form of breast cancer, others call it a 'pre-cancerous condition' because it often develops into an invasive cancer if it is not treated. Women who have had DCIS are at higher risk of getting cancer in the same breast and in the opposite breast as well as being more likely to develop more advanced forms of breast cancer.

1.Almac Initiates Talks with the FDA; Plans to market colorectal recurrence DX in 2008; May 29, 2007, Justin Petrone
http://www.bioarraynews.com/issues/7_22/features/140246-1.html

2. Ferlay J, Bray F, Pisani P, et al. Globocan 2002: Cancer Incidence, Mortality and Prevalence Worldwide,Version 2.0: IARC CancerBase no.5, Lyon, IARCPress, 2004.

3. "Early form of breast cancer on the rise", 25 January 2006, Cancer Research UK
http://info.cancerresearchuk.org/news/pressreleases/2006/january/86299

About Almac Diagnostics

Almac Diagnostics, a division of the Almac Group develops and delivers novel genomic research products, such as the Breast Cancer DSA™ research tool, to help accelerate the drug discovery pipeline from validation to market.

Using the range of proprietary Cancer DSA™ research tools, Almac Diagnostics develops clinical tests to improve the diagnosis and treatment of cancer patients.

The company also operates an accredited genomic services division, enabling academia, biotech and pharmaceutical companies to access high quality microarray processing and bioinformatics capabilities on an outsource basis.

Almac Diagnostics 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.

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