Screening test for colon cancer wins FDA approval

Aug 12 2014

The test, called Cologuard, can detect genetic mutations in patients' stool samples that are associated with cancerous and precancerous growths. 

The Wall Street Journal: FDA Approves DNA Test For Colon Cancer
The Food and Drug Administration on Monday approved a DNA test to screen for colon cancer in people with a lower risk of developing the disease, the first such test of its kind to be cleared by U.S. regulators. The test, called Cologuard, is used to detect genetic mutations in patients' stool associated with cancerous and precancerous growths in the colon. Doctors must prescribe the test, but patients collect stool samples at home and ship the samples to laboratories for analysis (Walker, 8/11).

Pioneer Press:  Mayo-Backed Colon Screening Tests Gets FDA Approval
The Food and Drug Administration on Monday announced approval for Cologuard, a new test kit developed in part at the Mayo Clinic for screening patients to assess their risk for colorectal cancer. In a related announcement Monday, the federal Centers for Medicare and Medicaid Services proposed that the federal Medicare cover costs for the new test. Colorectal cancer primarily affects people age 50 and older and is one of the most common causes of cancer-related death (Snowbeck, 8/11).

Bloomberg: Exact Sciences Wins U.S. Approval For Colon Cancer Test
The Food and Drug Administration cleared Cologuard, which screens stool samples for the presence of red blood cells and DNA mutations that may indicate the presence of cancer. Patients use Madison, Wisconsin-based Exact Sciences' test at home and those who have positive results are advised to get a colonoscopy, which uses a small video camera on the end of a thin tube to view the colon, the FDA said yesterday in a statement (Edney, 8/12).