Epigenomics AG appeals recent FDA request for additional information

Epigenomics AG  / Key word(s): Miscellaneous

25.11.2015 22:41

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

Epigenomics AG appeals recent FDA request for additional information

Berlin, Germany, November 25, 2015 - Epigenomics AG, Berlin, Germany,
(Frankfurt Prime Standard: ECX; ISIN: DE000A11QW50) the German-American
cancer molecular diagnostics company, today announced that after
discussions with FDA in relation to its premarket approval (PMA)
application for the Company's blood-based colorectal cancer (CRC) screening
test Epi proColon(R), it is appealing the agency's decision on additional
data requirements. Epigenomics is requesting a supervisory review of the
recent decision to require additional clinical data to support PMA
approval.

Epigenomics believes that an approval for the intended use of Epi
proColon(R) is warranted based on the data that has been submitted to date.
The Company has provided an extensive amount of data under its PMA
application and received a favorable recommendation by the FDA Medical
Device Advisory Committee in March 2014. Furthermore, in its appeal,
Epigenomics has highlighted the difficulties to measure adherence in the
intended use population under the existing regulatory framework along with
a willingness to work with FDA to design an appropriate post-approval
study.

FDA regulations provide several mechanisms to applicants for further review
of the agency's actions. A request for supervisory review is directed to
the next organizational level above the level at which the decision was
made. Based on respective guidelines and following discussions with FDA,
Epigenomics believes the supervisory review will be completed in Q1 2016.

Any decision on the company's appeal does not affect to the right of
Epigenomics to amend its PMA application in the future.

- 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.


25.11.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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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
 
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