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
GeneststraÃe 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
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Language: English
Company: Epigenomics AG
GeneststraÃe 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
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DGAP-Adhoc: Epigenomics receives FDA notification about status of pending approval decision for Epi proColon(R)
| Source: EQS Group AG