Epigenomics AG / Key word(s): Regulatory Approval/Miscellaneous 08.12.2014 08:05 Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China), December 08, 2014 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, and BioChain, a leading clinical diagnostics company in cancer and genetic testing in China and the U.S.A., announced today that the China Food and Drug Administration (CFDA) approved Epi proColon(R) for commercialization in China. Epi pro Colon(R) from Epigenomics is a non-invasive blood-based diagnostic test for colorectal cancer (CRC) detection based on the Septin9 DNA methylation marker. The approval was based on a major clinical validation study completed by BioChain in April 2014, which confirmed the previously demonstrated positive clinical performance of Epi proColon(R). While detecting 75% of all cancer cases at 97.5% specificity in the Chinese study, this test has the potential to become an important tool for medical professionals in establishing and expanding CRC detection in this country. The availability of CRC screening based on a blood sample will enable higher patient participation in detection of CRC as a means to reduce later stage disease and the associated costs. Epigenomics' partner in China, BioChain, expects to launch the product within the next weeks into the Chinese market through their established distribution channels and is currently preparing its market launch throughout the country. - End of Ad hoc - Contact Epigenomics AG Antje Zeise CIRO Manager IR | PR Epigenomics AG Phone: +49 (0) 30 24345 386 ir@epigenomics.com 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 by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology, which may be sold at some future time in the U.S. have not been established. 08.12.2014 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Epigenomics AG Geneststraße 5 10829 Berlin Germany Phone: +49 30 24345-0 Fax: +49 30 24345-555 E-mail: ir@epigenomics.com Internet: www.epigenomics.com ISIN: DE000A11QW50 WKN: A11QW5 Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart End of Announcement DGAP News-Service ---------------------------------------------------------------------------
08. December 2014 - 0:00 (CEST)