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First Noninvasive DNA Screening Test for Colorectal Cancer Gets FDA Approval

By Rhonda Reinhart

The U.S. Food and Drug Administration has approved the first stool-based colorectal screening test. Known as Cologuard, the test detects the presence of red blood cells and certain DNA mutations associated with colorectal cancer,  a cancer of the colon or rectum.

According to the Centers for Disease Control and Prevention, colorectal cancer is the third most common cancer, and the agency estimates that 60 percent of colorectal cancer deaths could be avoided if all people had regular screenings starting at age 50.

Along with Cologuard’s FDA approval comes news that the Centers for Medicare and Medicaid Services has proposed coverage guidelines for the test for Medicare beneficiaries.