The U.S. Food and Drug Administration has approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of cancers such as colon cancer or precursors to cancer. Cologuard is manufactured by Madison, WI-based Exact Sciences, Inc.
Using a stool sample, Cologuard detects hemoglobin, a protein molecule that is a component of blood. It also detects certain mutations associated with colorectal cancer (CRC) in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Patients with positive test results are advised to undergo a diagnostic colonoscopy.
The safety and effectiveness of Cologuard was established in a clinical trial that screened more than 10,000 subjects. The trial compared the performance of Cologuard to the fecal immunochemical test (FIT), a commonly used non-invasive screening test that detects blood in the stool. Cologuard was less accurate than FIT at correctly identifying subjects negative for colorectal cancer or advanced adenomas.
The Centers for Medicare & Medicaid Services (CMS) has issued a proposed national coverage determination for Cologuard, which is the first product reviewed through a joint FDA-CMS pilot program known as parallel review. In this program, the agencies concurrently review medical devices to help reduce the time between the FDA’s approval of a device and Medicare coverage. “Parallel review allows the last part of the FDA process to run at the same time as the CMS process, cutting as many as six months from the time from study initiation to coverage,” says Nancy Stade, deputy director for policy for the FDA’s Center for Devices and Radiological Health. Read more about Cologuard.
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