Epigenomics AG

EANS-News: Epigenomics AG Receives Allowance of Key Patent in the U.S.

Patent covers detection of colorectal cancer with Septin9 Biomarker

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Patents, Copyright & Trademarks/Molecular diagnostics

Subtitle: Patent covers detection of colorectal cancer with Septin9 Biomarker

Press release, Berlin, Germany, and Seattle, WA, USA, April 27, 2010 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics company, today announced that it has received a "Notice of Allowance" notification stating that the United States Patent and Trademark Office intends to grant a patent for Epigenomics' Septin9 DNA methylation biomarker (mSEPT9). The company received the grant of the corresponding patent in Europe in 2008. The application for which Epigenomics received the Notice of Allowance covers a method for the detection or classification of colorectal cancer by means of the DNA methylation status of the Septin9 gene.

Septin9 is at the core of the Epi proColon product, Epigenomics' in vitro diagnostic blood test for early detection of colorectal cancer. The test is based on the detection of methylated Septin9 DNA (mSEPT9) in blood. This epigenetic modification of the Septin9 gene can be detected in the vast majority of tumors in the colon and rectum. As tumors shed DNA into the bloodstream, the detection of circulating methylated Septin9 DNA with the sensitive Epi proColon assay is a reliable indicator of acute colorectal cancer. In October 2009 Epi proColon has been introduced as a CE-marked in vitro diagnostic product in Europe.

Following the receipt of the patent allowance Geert Nygaard, CEO of Epigenomics, commented: "Receiving the grant of the Septin9 patent in the U.S. significantly strengthens our intellectual property portfolio. We now have patents covering the Septin9 biomarker in our colorectal cancer screening business in Europe as well as the U.S. This strong patent position for diagnostic content is at the heart of our business model and we leverage this asset in our deals with diagnostic industry partners such as Abbott, Sysmex, Quest and ARUP as well as direct commercialization in certain market segments."

Dr. Andrew Sledziewski, Senior Vice President of Research at Epigenomics added: "The Septin9 patent is one of multiple biomarker patent applications we have filed over the past several years covering novel DNA methylation biomarkers in many cancer indications. The current Notice of Allowance further validates the innovative nature of our Septin9 colorectal cancer blood test and underscores our company's leadership in molecular diagnostics based on DNA methylation."

About Epi pro Colon

Epi proColon is Epigenomics' CE-marked, in vitro diagnostic real-time PCR test kit for the qualitative detection of Septin9 gene methylation in cell-free bisulfite converted DNA isolated from human plasma samples. Presence of methylated Septin9 DNA is associated with, and may aid in the detection of, invasive colorectal adenocarcinoma.

For more information on the Epi proColon test and its availability and distribution options in Europe please visit www.epiprocolon.com or contact Epigenomics directly by Email sales@products.epigenomics.com or phone +49 30 24345 111.

Epi proColon is not for sale in the United States of America. The analytical and clinical performance characteristics of the product have not been evaluated by the US Food and Drug Administration. The product is CE-marked in compliance with the European IVD Directive 98/79/EC.

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 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 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, 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.

end of announcement                               euro adhoc
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Further inquiry note:

Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

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