Epi proColon 2: Clinical trial data
A Chinese clinical validation trial in 1,074 patients showed that Epigenomics' Epi proColon 2.0 test had 74.8% sensitivity and 97.4% specificity for detecting colorectal cancer. Additionally, Epigenomics said partner BioChain Institute Inc. (Newark, Calif.) submitted an application for Epi proColon 2.0 to China's Food and Drug Administration (CFDA) in April. BioChain has exclusive Chinese rights from Epigenomics to develop and commercialize the test under an expanded 2013 deal (see BioCentury, Nov, 4, 2013). Epi proColon 2.0 is under Priority Review in the U.S., with a decision expected this half. In March, the Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee voted 5-4, with 1 abstention, that the benefits of Epi proColon 2.0 outweigh the product's risks (see BioCentury, March 31). ...