BioCentury
ARTICLE | Company News

FDA committee to discuss Epi proColon 2.0

November 27, 2013 11:28 PM UTC

Epigenomics AG (Xetra:ECX) said FDA set a tentative date of March 25 for a meeting of its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to discuss a PMA for Epigenomics' colorectal cancer test Epi proColon 2.0. In February, Epigenomics said FDA accepted and granted Priority Review to a PMA for the product. At the time, the company said it expected a decision on the PMA this half. However, last month Epigenomics declined to reiterate the timeline, citing uncertainties due to the government shutdown. ...