Exact Sciences Says FDA Oks Stool DNA Colorectal Cancer Screening Test Cologuard

(RTTNews) - Exact Sciences Corp. (EXAS) announced that the U.S. Food and Drug Administration or FDA has approved Cologuard, the company's noninvasive, stool DNA colorectal cancer screening test.

Cologuard is available to patients through their healthcare providers in the U.S. for $599. The company said it has plans to make Cologuard available in select countries in Europe pending CE Mark.

Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients.

Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy-to-use screening test they can do in the privacy of their own home.

Upon approval, Exact Sciences also received a proposed coverage memorandum from the Centers for Medicare and Medicaid Services (CMS). Cologuard is the first product to take part in the joint FDA and CMS parallel review pilot program in which both agencies simultaneously review medical devices to help reduce the time between FDA approval and Medicare coverage. A final National Coverage Determination is expected to be posted in October/November of this year after a public comment period.

Cologuard is designed to detect biomarkers from DNA in cancer that is shed from the colon as part of the digestive process and blood released in the stool. After the physician orders Cologuard, the kit is mailed directly to the patient's home. The patient then collects a stool sample in the Cologuard Collection Kit and sends the kit back to the Exact Sciences lab for testing through a pre-paid mailer.