Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China) – 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® for commercialization in China. Epi pro Colon® 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®. 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.
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