DGAP-News

Epigenomics AG: Epigenomics and BioChain Announce Approval of Epi proColon(R) in China

DGAP-News: Epigenomics AG / Key word(s): Regulatory Approval
Epigenomics AG: Epigenomics and BioChain Announce Approval of Epi
proColon(R) in China

08.12.2014 / 08:05

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Epigenomics and BioChain Announce Approval of Epi proColon(R) in China

Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.) and 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 proColon(R) is Epigenomics' 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.

James Wang, Chairman of BioChain, commented: "We are delighted by the CFDA
approval of Epi proColon(R) which is a key milestone for our company,
allowing us to address colorectal cancer detection in China with this
highly innovative product. We believe this product with high sensitivity,
specificity and expected compliance will benefit the Chinese people and
society. These benefits will not only be seen in the way of providing an
early diagnostic tool to lower the CRC morbidity and mortality and reduce
the cost in CRC prevention and therapy, but also by way of emphasizing the
importance of early screening, diagnosis and intervention, therefore
enhancing the health of all Chinese people. We thank Epigenomics for the
excellent support provided during the approval process and we now look