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Epigenomics Licenses Septin 9 Colorectal Cancer Biomarker to Quest Diagnostics

February 19, 2008

BERLIN, Feb. 19, 2008 (PRIME NEWSWIRE) — Epigenomics AG (Frankfurt:ECX) (Other OTC:EPGNF), a cancer molecular diagnostics company, today announced that it signed a non-exclusive licensing agreement for its proprietary DNA methylation biomarker Septin 9 with U.S. based Quest Diagnostics Incorporated (NYSE:DGX), the leading provider of diagnostic testing, information and services. Under the agreement, Quest Diagnostics has obtained rights to uses of the Septin 9 DNA methylation biomarker to develop a molecular-based laboratory test that can help physicians detect colorectal cancer based on a patient’s blood specimen. Colorectal cancer is the second leading cause of cancer-related deaths in the U.S. Epigenomics has demonstrated that methylated DNA of the Septin 9 gene in blood plasma indicates the presence of colorectal cancer in early stages.(1) Quest Diagnostics plans to develop the Septin 9 DNA methylation test to actas a supplement to conventional methods of colorectal cancerscreening, including colonoscopy and fecal occult blood tests (FOBTs).

“The availability of a simple blood test that can detect a biomarker for colorectal cancer will be a significant advance in the fight against this deadly disease, which is often curable when caught in the early stages,” said Joyce G. Schwartz, M.D., vice president and chief laboratory officer, Quest Diagnostics. “Patient compliance in the U.S with colorectal cancer screening guidelines is dismal. Too often, patients fail to undergo a colonoscopy or conduct other types of colorectal cancer screenings because they find these methods invasive, unpleasant or costly. A blood test for detecting colorectal cancer, once developed, will be a convenient option that complements other screening methods.”

Quest Diagnostics is the first commercial laboratory in the U.S. to non-exclusively license the Septin 9 biomarker from Epigenomics with the goal of commercializing a laboratory-developed blood test. As a first-mover advantage, Quest Diagnostics was granted exclusivity for an undisclosed period in the U.S. In return for the Septin 9 rights, Epigenomics receives upfront and milestone payments as well as royalties on Quest Diagnostics’ sales of its Septin 9 based tests. Additional terms were not disclosed.

Quest Diagnostics’ extensive experience in DNA methylation diagnostics includes offering tests for Prader-Willi and Angelman Syndromes, two neurologic epigenetic disorders that may be caused by faulty DNA methylation.

“Quest Diagnostics is an ideal diagnostic company to use our Septin 9 biomarker technology to commercialize a laboratory developed test for detecting colorectal cancer,” said Geert Nygaard, chief executive officer of Epigenomics. “We selected Quest Diagnostics because they have a record of innovation in diagnostics, including development of other DNA methylation diagnostic tests. They also share our goal to develop technologies that will help physicians achieve improved health outcomes for their patients through accurate detection of early-stage colorectal cancer.”

Colorectal cancer, which refers to cancer of the colon and rectum, is expected to have caused approximately 52,000 deaths in the U.S. in 2007. Patients with colorectal cancer detected in its earliest stage have a 90 percent chance of five-year survival. Although guidelines from the American Cancer Society (ACS) recommend that all men and women of average risk should begin regular screening at 50 years of age or older, a recent study found that only about one in four patients receiving Medicare received guideline-based follow-up screening between 1998 and 2004.(2) Screening methods include colonoscopy, the screening gold standard, once every ten years, as well as flexible sigmoidoscopy, double-contrast barium enema and FOBTs.

“With today’s licensing agreement we continue to execute on our non-exclusive commercialization strategy for our colorectal cancer biomarker. The agreement with Quest Diagnostics for the commercialization of a laboratory developed test for Septin 9 complements our agreement with Abbott Molecular who obtained the non-exclusive rights to commercialize IVD test kit products based on Septin 9 in September 2007,” explained Mr. Nygaard.

References

(1) Lofton-Day C et.al. (2008): DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem. 54:414-23.

(2) Cooper GS and Doug Kou T (2008): Underuse of colorectal cancer screening in a cohort of Medicare beneficiaries. Cancer 112: 293-9.

About Epigenomics’ Septin 9 Biomarker

Epigenomics’ technology aims at sensitively detecting DNA based on specific DNA methylation patterns in blood plasma samples or other body fluids. The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with about 3,000 blood plasma samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer in early stages. As a first strategic partner, Abbott Molecular, Inc. licensed the worldwide non-exclusive rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer in September 2007. The companies anticipate launching a CE-marked blood test in Europe in 2009 followed by regulatory filing for U.S. approval in 2010. About DNA Methylation

DNA methylation is a natural and tightly controlled biological process that serves the regulation of genes and the stability of the human genome. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps control gene activity. Every cell type has its unique DNA methylation “fingerprint” that changes in various normal biological processes and in many diseases, in particular cancer. In our opinion, DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests can potentially diagnose cancer at an early stage and help guide physicians to select an appropriate therapy. Epigenomics’ defined business strategy covers two complementary core business areas: The company develops diagnostic screening tests for the early detection of cancer. Based on body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics’ product pipeline contains a validated biomarker panel for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids. Epigenomics aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry companies. As a first strategic partner, Abbott Molecular, Inc. licensed the worldwide non-exclusive rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer. As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen GmbH (pre-analytics) and Affymetrix, Inc. (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe. Pharma, diagnostics and biotech partners can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families (granted patents and patent applications) through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

This news release was distributed by PrimeNewswire, www.primenewswire.com

 CONTACT: Epigenomics AG          Dr. Achim Plum, Vice President, Corporate Communications                 +49 (0) 30 24345 368          Fax: +49 (0) 30 24345 555          achim.plum@epigenomics.com          Kleine Prasidentenstr.1          10178 Berlin          Deutschland 




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