Berlin, Germany, and Seattle, WA, USA, November 2, 2009 -- The cancer molecular diagnostics company Epigenomics AG (Frankfurt Prime Standard: ECX) today announced that Quest Diagnostics Incorporated, Madison, NJ, U.S.A., the world’s leading provider of diagnostic testing, information and services, successfully completed the clinical validation of its Septin9-based laboratory-developed test for aiding the detection of colorectal cancer. Under terms of a license agreement between the companies for Epigenomics’ proprietary DNA methylation biomarker Septin9, Epigenomics will receive a milestone payment from Quest Diagnostics upon reaching this milestone. The amount of the payment was not disclosed.
“Validation of our Septin9 laboratory-developed test is an important step forward in providing a test that physicians can use to help them identify patients with colorectal cancer,” said Jay G. Wohlgemuth, M.D., Vice President of Science and Innovation, Quest Diagnostics. “We intend to release the test in the U.S. later this year.”
“Quest Diagnostics’ successful development and validation of a laboratory-developed blood test based on Septin9 is an important step forward in making this innovative approach to colorectal cancer detection broadly available,” commented Geert Nygaard, Chief Executive Officer of Epigenomics. “We are confident that this patient-friendly option for colorectal cancer testing, once brought to market in the U.S., will help reduce mortality from this disease among Americans.” 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 on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.
Epigenomics’ product portfolio contains Epi proColon, a CE-marked IVD blood test for the early detection of colorectal cancer based on the validated biomarker mSEPT9, and further proprietary DNA methylation biomarkers at various stages of development for colorectal, prostate and lung cancer detection in blood, urine and bronchial lavage specimens. Epigenomics’ biomarker mSEPT9 for the early detection of colorectal cancer in a simple blood sample has demonstrated continuously highest performance in eight clinical case-control studies with in total more than 3,300 individuals tested. A large prospective clinical study -- PRESEPT -- to evaluate the performance characteristics and the health economic benefit of colorectal cancer screening with the mSEPT9 biomarker in a representative screening population currently under way (www.presept.net). Once completed, the PRESEPT Study will be one of the largest commercially sponsored colorectal cancer screening clinical studies ever conducted. The clinical performance and health economic analysis results are expected to support future coverage of mSEPT9 testing by public and private health insurers worldwide. Epigenomics’ partners developing IVD test kits for the mSEPT9 biomarker can co-fund and access the PRESEPT sample collection to conduct clinical trials for regulatory filings in the U.S.
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, Philips, 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.
Partners in the health care industry and the biomedical research community can access Epigenomics’ portfolio of proprietary DNA methylation technologies and biomarkers through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics’ website at www.epigenomics.com. 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 in the United States.
The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
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