Colon Cancer Screening Test Receives FDA Approval, Proposed Medicare Coverage

The CMS and the FDA concurrently issued decisions Aug. 11 aimed at providing access to a colon cancer screening test.

The Food and Drug Administration approved Cologuard, manufactured by Exact Sciences Corp. of Madison, Wis. According to the FDA, Cologuard is a stool-based DNA screening test used to detect abnormalities that may indicate colon cancer. The FDA Molecular and Clinical Genetics Panel March 27 voted 10-0 in favor of approval for the Cologuard test.

Cologuard was approved under a pilot program involving the FDA and the Centers for Medicare & Medicaid Services conducting a parallel review. The agencies first announced ...