FDA panel split on Epigenomics' Epi ProColon

The Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee voted 5-4, with one abstention, that the benefits of colorectal cancer test Epi proColon 2.0 from Epigenomics AG (Xetra:ECX) 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 one abstention. Epi proColon 2.0 is a blood-based test that detects methylated DNA of the Septin 9 gene. ...