Epigenomics AG: FDA requests further data for approval of Epigenomics’ blood-based colorectal cancer screening test

Epigenomics AG  / Key word(s): Regulatory Admission

04.11.2015 20:19

Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
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The issuer is solely responsible for the content of this announcement.

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FDA requests further data for approval of Epigenomics' blood-based
colorectal cancer screening test

Berlin, Germany, November 4, 2015 - Epigenomics AG, Berlin, Germany,
(Frankfurt Prime Standard: ECX, ISIN: DE000A11QW50), announces that it has
received a response letter from the U.S. Food and Drug Administration (FDA)
in relation to its premarket approval (PMA) application for the Company's
blood-based colorectal cancer (CRC) screening test Epi proColon(R).

In its letter, the FDA provided guidance and recommendations on how to
amend the PMA to make it approvable. The agency requested additional data
demonstrating that the blood-based Epi proColon(R) test will increase
compliance to CRC screening in the intended use population, i.e. in those
patients with a history of noncompliance to recommended CRC screening
programs.

The management of Epigenomics is taking immediate steps to address the
FDA's requests. This includes a meeting with the FDA in the near-term in
order to discuss how to best address the outstanding questions. It is
expected that an additional study to demonstrate increased compliance and
adherence of patients to blood-based CRC testing will be needed. Details of
the study will be determined in dialogue with the FDA. As in the past,
Epigenomics is committed to provide information about the regulatory way
forward to its shareholders and to the public in a timely and comprehensive
manner.

Together with its strategic commercialization partner Polymedco,
Epigenomics will continue to diligently prepare for commercializing Epi
proColon(R) in the United States.

In the previous ADMIT (Adherence to Minimally Invasive Testing) study,
Epigenomics aimed to demonstrate that Epi proColon(R) will increase CRC
participation in patients being offered this convenient blood-based test as
compared to those being offered a fecal immunochemical test (FIT). While
the adherence to Epi proColon(R) was nearly 100%, the participation rate to
the FIT-test of 88% by far exceeded the levels seen in many studies. The
FDA's request for additional data suggests that the studied population in
the ADMIT trial was not fully suitable for 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.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.


04.11.2015 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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