BioCentury
ARTICLE | Clinical News

Epi proColon 2 regulatory update

February 10, 2014 8:00 AM UTC

The Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee will meet on March 26 to discuss a PMA for Epi proColon 2.0 from Epigenomics for early detection of colorectal cancer. The product is under Priority Review, with a decision expected this half. Epi proColon 2.0 is a second-generation test that uses real-time PCR to detect methylated DNA of the Septin 9 gene in blood plasma. Epigenomics markets a first-generation version in Europe. Epigenomics previously said FDA sent a tentative date of March 25 for the meeting. ...