Epi proColon 2 diagnostic data

Epigenomics reported data from a U.S. validation study evaluating plasma samples selected from a cohort of 7,940 subjects who had an average risk for colorectal cancer and underwent colonoscopy showing that its Epi proColon 2.0 test had 68% sensitivity and 80% specificity for detecting colorectal cancer. The test cohort included 45 cases of colorectal cancer. Epigenomics said that although the results were at the lower end of the expected performance data, the findings confirm the results from a previous study with the company's first-generation Epi proColon test, which is marketed in Europe. In a 2009 validation study, the first-generation assay showed 67% sensitivity at comparable specificity to that of the second-generation test. Epi proColon 2.0 uses reagents and instruments manufactured under cGMP regulations.

Based on discussions with FDA, Epigenomics confirmed that data from the U.S. validation study will be included in a PMA for Epi proColon 2.0. The company plans to submit the first module of the application to FDA this month, with an FDA panel review expected in 2012. Epigenomics also plans to conduct a head-to-head non-inferiority study comparing Epi proColon 2.0 to fecal immunochemical testing. The study, which is expected to be completed next year, will also be included in the company's PMA. ...