Epigenomics AG / Key word(s): Regulatory Approval/Miscellaneous
08.12.2014 08:05
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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Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China),
December 08, 2014 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX:
EPGNY), the German-American cancer molecular diagnostics company, and
BioChain, a leading clinical diagnostics company in cancer and genetic
testing in China and the U.S.A., announced today that the China Food and
Drug Administration (CFDA) approved Epi proColon(R) for commercialization
in China. Epi pro Colon(R) from Epigenomics is a non-invasive blood-based
diagnostic test for colorectal cancer (CRC) detection based on the Septin9
DNA methylation marker.
The approval was based on a major clinical validation study completed by
BioChain in April 2014, which confirmed the previously demonstrated
positive clinical performance of Epi proColon(R). While detecting 75% of
all cancer cases at 97.5% specificity in the Chinese study, this test has
the potential to become an important tool for medical professionals in
establishing and expanding CRC detection in this country. The availability
of CRC screening based on a blood sample will enable higher patient
participation in detection of CRC as a means to reduce later stage disease
and the associated costs. Epigenomics' partner in China, BioChain, expects
to launch the product within the next weeks into the Chinese market through
their established distribution channels and is currently preparing its
market launch throughout the country.
- End of Ad hoc -
Contact Epigenomics AG
Antje Zeise CIRO
Manager IR | PR
Epigenomics AG
Phone: +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com
Epigenomics' legal disclaimers. 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.
08.12.2014 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: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of Announcement DGAP News-Service
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08. December 2014 - 0:00 (CEST)