Epigenomics AG / Key word(s): Regulatory Approval 13.04.2016 08:06 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. --------------------------------------------------------------------------- Ad-hoc release Epigenomics receives FDA approval for Epi proColon(R) Berlin (Germany) and Germantown, MD (U.S.A.), April 13, 2016 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's lead product, Epi proColon(R), the first and only FDA-approved blood-based colorectal cancer screening test. Epi proColon(R) will be made available in the United States under a joint commercialization agreement with the Company's strategic partner Polymedco, a leader in non-invasive colorectal cancer screening technology. Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests (FIT). For patients, the test only requires a simple blood sample to be drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a local or regional diagnostic laboratory. Epi proColon(R) has received FDA approval based on demonstration of safety and efficacy as established in three major clinical studies. The test has also demonstrated its potential to significantly increase participation rates in colorectal cancer screening. As typically required by the FDA for new screening products, the Company will initiate a post-approval study to show the long-term benefit of blood-based colorectal cancer screening using Epi proColon(R). - end of ad-hoc- Contact Epigenomics AG Peter Vogt, Investor & Public Relations Epigenomics AG Geneststraße 5 10829 Berlin Phone +49 (0) 30 24345 386 ir@epigenomics.comHomeEpigenomics legal disclaimer 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. 13.04.2016 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: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart End of Announcement DGAP News-Service ---------------------------------------------------------------------------
13. April 2016 - 0:00 (CEST)