FDA committee to discuss Exact Sciences' Cologuard

Exact Sciences Corp. (NASDAQ:EXAS) said FDA set a tentative date of March 26 for a meeting of its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to discuss a PMA for Cologuard as a colorectal cancer screening test. The company submitted the final module of the PMA in June. Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene (see BioCentury, June 24). ...