Epi proColon 2 regulatory update

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