EANS-Adhoc: Ad Hoc Announcement pursuant of §15 WpHG (German Securities Trading Act) Epigenomics AG Launches Colorectal Cancer Blood Test Epi proColon in Europe
ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro adhoc with the aim of a Europe-wide distribution. The issuer is solely responsible for the content of this announcement.
New Products/Molecular diagnostics
06.10.2009
Epigenomics AG (ISIN: DE000A0BVT96), a cancer molecular diagnostics company, today announced, that it launched in Europe a CE-marked, in vitro diagnostic blood test for early detection of colorectal cancer. The test, which is marketed under the brand name Epi proColon, is a molecular diagnostic test that can detect tumor derived methylated DNA of the Septin9 gene (mSEPT9) in blood plasma as a biomarker for colorectal cancer. Epi proColon is the first in vitro diagnostic blood test for the early detection of colorectal cancer that is available in Europe as CE-marked product in accordance with European regulations for in vitro diagnostic (IVD) products.
In a performance evaluation study, the final step of Epigenomics' IVD product development, analyzing blood samples from about 260 patients with colorectal cancer or without any evidence of colorectal cancer, the Epi proColon test detected two thirds of the cancer cases in early, still localized disease stages. When colorectal cancer is still localized, i.e. has not spread to lymph nodes or distant organs, about 90% of the patients can be cured from the disease (90% 5-year survival rate). Across all disease stages, the study confirmed results from previous clinical studies with the mSEPT9 biomarker in detecting about 70% of all cancer cases at about 90% specificity. The test aims at patients who should undergo colorectal cancer screening but reject current methods for colorectal cancer early detection such as stool tests and invasive colonoscopy.
Epi proColon is the first CE-marked IVD product that Epigenomics markets directly to molecular diagnostic laboratories in Europe. Epigenomics aims at serving the home market in Germany, Austria and Switzerland through direct marketing and sales, while initially commercializing through distributors in other European markets.
In addition to direct commercialization, Epigenomics continues to pursue its non-exclusive licensing strategy for its mSEPT9 biomarker for colorectal cancer blood testing and is working with several partners in the diagnostics industry. Of these, Abbott Molecular, Chicago, IL, U.S.A. and Quest Diagnostics, Giralda Farms, NJ, U.S.A., are expected to start offering their mSEPT9 tests in Europe and the U.S.A., respectively, in the fourth quarter of 2009.
End of ad hoc
Further Information
For further information please see today's press release on the launch of the Epi proColon product at HYPERLINK "http://www.epigenomi cs.com/en/Newsroom/"http://www.epigenomics.com/en/Newsroom/. Epigenomics' management will host a conference call for investors and media on the Epi proColon launch and its strategy going forward at 4pm CET today, Tuesday, October 6, 2009. The dial-in numbers for the conference call are:
Dial-in number (within Germany): +49 (0)69 247 501 891 Dial-in number (within the US): +1 212 444 0297
Participants are kindly requested to dial in 10 minutes prior to the start of the call.
The presentation accompanying the conference call will be available at 3 pm for download on the Epigenomics website: http://www.epigenomics.com/en/down_loads/corporate_material/
A recording of the conference call will be provided on Epigenomics' website subsequently: http://www.epigenomics.com/en/down_loads/corporate_material/
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.
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, Technologie All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
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München / free trade