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FDA posts briefing docs for colorectal cancer tests

March 25, 2014 12:17 AM UTC

FDA reviewers provided a summary of the efficacy data for two colorectal cancer tests but did not take a position on approval of the products in Epi proColon 2.0, a blood-based test that detects methylated DNA of the Septin 9 gene, from Epigenomics AG (Xetra:ECX). On Thursday, the advisory committee will discuss Cologuard, a non-invasive stool DNA test, from Exact Sciences Corp. (NASDAQ:EXAS). For both tests, FDA is asking the committee to vote on whether the products are safe and effective for the proposed use, and whether the benefits outweigh the risks. ...