Epigenomics AG Receives Allowance of Key Patent in the U.S.

Patent covers detection of colorectal cancer with Septin9 Biomarker

29-Apr-2010 - Germany

Epigenomics AG 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 a 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.”

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