Exact Sciences’ Cologuard wins FDA approval

Madison-based Exact Sciences Corp. got the news it had long been waiting for on Monday: After nearly two decades of work, research, and clinical trials, the U.S. Food and Drug Administration approved Cologuard, the company’s non-invasive diagnostic test for colon cancer, on a unanimous 10-0 vote. The stool-based, DNA-based test detects amounts of hemoglobin and certain DNA mutations in the blood and is intended for people 50 years or older who are considered at average risk for the disease.

On the same day, the Centers for Medicare & Medicaid Services (CMS) issued a preliminary decision on the cost of the Cologuard test and recommended a three-year testing interval for people aged 50 to 85 with no cancer symptoms. That proposal is subject to a 30-day comment period, with final action expected in November.

The company will begin working with insurance companies immediately, and the test will be available for physicians to order starting Sept. 2. The cost is $599.