Epi proColon secures Chinese commercialization
BERLIN & GERMANTOWN, Md.—As announced by Epigenomics AG and BioChain, the China Food and Drug Administration has approved the Epi proColon diagnostic test for colorectal cancer (CRC) for commercialization in China. A major clinical validation study showed the test capable of detecting 75 percent of all cancer cases at 97.5-percent specificity in the Chinese study. BioChain expected to launch the test within weeks of gaining approval.
“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,” said Dr. Thomas Taapken, Epigenomics' CEO and chief financial officer. “We now look forward to working closely with our partner BioChain on the launch of this very important diagnostic tool. 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.”