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Berlin, Germany, and Tel Aviv, Israel, October 14, 2010 - Epigenomics AG (Frankfurt Prime Standard: ECX) and Pronto Diagnostics Ltd. today announced that they have signed an exclusive distributor agreement for the commercialization of Epigenomics’ Epi proColon test in Israel.
Epi proColon is the world’s first CE-marked molecular diagnostic test for the early detection of colorectal cancer in blood. The test is based on Epigenomics’ proprietary biomarker Septin9. Pronto Diagnostics expects to begin marketing the test in Israel in November 2010.
Colorectal cancer is one of the most prevalent cancers in Israel with 3,200 new patients diagnosed each year (Israel Cancer Association). Everyone over the age of 50 is recommended to be tested for colorectal cancer every two years. Colorectal cancer is curable and patients diagnosed with it have a good chance of recovery provided that the cancer is detected early enough when it is still in the localized stages.
“Epi proColon facilitates the early detection for colorectal cancer making diagnosis easier and more patient-friendly than ever,” Dr. Nir Navot, Chief Executive Officer of Pronto Diagnostics explained. “This test can be performed along with other routine blood tests and does not require any preparation of the screened individual. We expect that a significantly higher number of people will be prepared to undergo screening for colorectal cancer with this new test than with current methods such as stool tests and colonoscopy alone.”
Epi proColon is currently marketed by Epigenomics directly in Germany, Austria and Switzerland. Outside this home market, it is Epigenomics’ strategy to make the CE-marked test broadly available through a mix of direct commercialization and a distributor network.
“We are delighted to have signed-up Pronto Diagnostics as our exclusive Israeli distributor for Epi proColon. The team at Pronto Diagnostics has exactly the expertise and experience we were looking for,” commented Geert Nygaard, Chief Executive Officer of Epigenomics. “With this agreement we have begun expanding our commercial reach beyond the home market. We will continue this expansion and expect to enter into distribution agreements for further regions in the near future.”
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development aim at detecting cancer before symptoms occur and thereby potentially reducing mortality from this disease.
Epigenomics’ product portfolio contains the CE-marked IVD test Epi proColon, the world’s first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development and commercialization for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.
About Pronto Diagnostics
Pronto Diagnostics is a leading provider of molecular diagnostic products with extensive knowledge, experience, and R&D capabilities in SNP-based analysis of genetic variations.
The company specializes in developing and marketing diagnostic kits for clinical diagnosis of genetic disease, carrier screening, prenatal testing, disease predisposition, and differential diagnosis and is active in the rapidly growing field of pharmacogenetics and personalized medicine. For more information see www.prontodiagnostics.com.
Notes for editors
Epi proColon, developed by Epigenomics, detects the methylated DNA of the Septin9 gene in blood plasma. This Septin9 biomarker has been shown in numerous clinical studies to be closely associated with the presence of colorectal cancer and may aid in the detection of this common cancer. Septin9 is one of the best and most systematically validated biomarkers for the early detection of colorectal cancer today. In particular, the recent PRESEPT study was a successful prospective evaluation of Epi proColon detection of methylated Septin9 in a cohort of about 8,000 individuals representative of a typical screening population.
Epigenomics’ legal disclaimers. 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.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the USA have not been established.NEXT ARTICLE
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