Epi proColon 2 regulatory update

Epigenomics submitted the third module of a PMA to FDA for its Epi proColon 2.0 test to detect colorectal cancer. The company said the module included the analytical performance of the test in terms of accuracy, precision and stability. The company plans to submit the last module next half. The last module will include data from an ongoing head-to-head non-inferiority study comparing Epi proColon 2.0 to fecal immunochemical testing as well as a completed U.S. validation study. The company began submission of the test earlier this year (see BioCentury, Dec. 19, 2011 & Jan. 9, 2012). ...