DGAP-Adhoc

Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics' Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon(R) in China

Epigenomics AG / Key word(s): Study/Miscellaneous

24.04.2014 12:10

Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company 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),
April 24, 2014 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX:
EPGNY), and BioChain Institute Inc. (BioChain), today announced that
BioChain has completed its major clinical validation study to validate
Epigenomics' blood-based Septin9 screening assay Epi proColon(R) for the
early detection of colorectal cancer (CRC) with the goal to gain market
approval for the test in China. In addition, BioChain has officially
submitted an application to the China Food and Drug Administration (CFDA)
in April for the approval of Epi proColon(R). Both companies expect
commercialization of the test in China to start in 2015.

The clinical validation study was designed to evaluate the clinical
performance of Epi proColon(R) for the detection of CRC and is part of the
required data package to seek regulatory approval in China. From November
2013 to March 2014, a total of 1,074 patients at three top ranking
hospitals in China were tested by using Epigenomics' Epi proColon(R) 2.0 CE
assay. Epi proColon(R) detected 74.8% of the cancer cases (sensitivity) and
correctly identified 97.4% of the patients free of disease (specificity).
The tested study cohort included 300 cancer cases in stages I to IV. The
results were marked as positive when at least two out of three samples of
the test triplicate were evaluated as positive.

The results were in line with those achieved in Epigenomics' European CE
marking study reported in 2011, which followed the same principle of data
interpretation (80% sensitivity and 99% specificity).

- End of Ad hoc -

Contact Epigenomics AG

Antje Zeise CIRO
Manager IR | PR
Epigenomics AG
Phone: [phone]

[e-mail]
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.


24.04.2014 DGAP's 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
Kleine Präsidentenstraße 1
10178 Berlin
Germany
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
Internet: www.epigenomics.com
ISIN: DE000A1K0516
WKN: A1K051
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart

End of Announcement DGAP News-Service

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