ARTICLE | Clinical News

Epi proColon 2 regulatory update

March 31, 2014 7:00 AM UTC

The Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee voted 5-4, with 1 abstention, that the benefits of colorectal cancer test Epi proColon 2.0 from Epigenomics outweigh the product's risks. Concerns about the test's efficacy were what divided the panel. After the panel voted 5-5 that Epi proColon 2.0 is effective to screen patients at average risk for colorectal cancer, the panel chair voted no to break the tie.

The panel was nearly unanimous that Epi proColon 2.0 is safe in the indication, voting 9-0 in favor, with 1 abstention. Epigenomics said it plans to meet with FDA in the next 4-6 weeks to discuss product labeling and a proposed postmarketing study for Epi proColon 2.0. The product is under Priority Review, with a decision expected this half. ...