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® for commercialization in China. Epi proColon® 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®. 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 blood-based CRC screening 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 few 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® which is a key milestone for our company, allowing us to address colorectal cancer detection in China with this highly innovative product. We believe that this product with its 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 to 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 forward to bringing this effective and non-invasive option to the people eligible for CRC screening in our country.”
“We are extremely pleased to announce the approval of Epi proColon® in the important Chinese market. BioChain has been incredibly efficient in driving this approval process in a very short time. We now look forward to working closely with our partner BioChain on the launch of this very important diagnostic tool,” added Epigenomics’ CEO/CFO Dr. Thomas Taapken. “We are convinced that our test will help to reduce the mortality and costs of care associated with CRC in China through the early identification of the disease.”