DGAP-Ad hoc: Epigenomics AG

DGAP-Adhoc: Epigenomics receives FDA notification about status of pending approval decision for Epi proColon(R)

Epigenomics AG / Key word(s): Regulatory Admission

08.01.2016 07:55

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.

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Ad Hoc Announcement pursuant to Sec. 15 WpHG (German Securities Trading Act)

Epigenomics receives FDA notification about status of pending approval decision for Epi proColon(R)

Berlin, Germany, January 8, 2016 - Epigenomics AG, Berlin, Germany, (Frankfurt Prime Standard: ECX; ISIN: DE000A11QW50) the German-American cancer molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that the already submitted and available data for Epigenomics' blood-based colorectal cancer (CRC) screening test Epi proColon(R) would allow the agency to come to a final determination on its safety and effectiveness. Given that no new data would be required before reaching a final decision on the premarket approval ("PMA") submission, FDA would expect that final stages of the review process would be completed in the near future.

According to the FDA, final approval of the Company's application is subject to the resolution of minor outstanding topics, such as the use of appropriate language in the product labeling.

Epigenomics will work closely with the FDA to reach the final approval decision within the next few months.

Upon approval, Epi proColon(R) would be the first and only FDA-approved blood-based test for the detection of colorectal cancer. Epi proColon(R) will be made available in the United States jointly with the Company's strategic commercialization partner Polymedco.

- 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.com

www.epigenomics.com

Epigenomics 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.

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.

08.01.2016 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: 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 ---------------------------------------------------------------------------