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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

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. 13.04.2016 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at and --------------------------------------------------------------------------- Language: English Company: Epigenomics AG Geneststraße 5 10829 Berlin Germany Phone: +49 30 24345-0 Fax: +49 30 24345-555 E-mail: Internet: 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 ---------------------------------------------------------------------------