colon cancer screening test wins FDA approval -
The test, called Cologuard, can detect genetic mutations in stool samples of patients that are associated cancerous and precancerous tumors.
The Wall Street Journal: The FDA approves DNA test for colon cancer
The Food and Drug Administration on Monday approved a DNA test to detect colon cancer in people with a lower risk of developing the disease, the first such test of its kind to be approved by US regulators. The test, called Cologuard, is used to detect genetic mutations in the stool of patients associated with cancer and precancerous growths in the colon. Doctors must prescribe the test, but patients collect stool samples at home and send samples to laboratories for analysis (Walker, 8/11)
Pioneer Press. Mayo-Backed Colon Screening Tests Gets FDA Approval
Food and Drug Administration announced Monday approval for Cologuard, a new test kit developed in part at the Mayo Clinic for patient screening to assess their risk colorectal cancer. In a related announcement on Monday, the federal Centers for Medicare and Medicaid Services has proposed that the federal Medicare cover the costs for the new test. Colorectal cancer mainly affects people aged 50 and over and is one of the most common causes of cancer deaths (Snowbeck, 8/11)
Bloomberg :. Exact Sciences of the United States wins approval for Colon cancer test
the Food and Drug Administration manages Cologard, which screens stool samples for the presence of red blood cells and DNA mutations that can indicate the presence of cancer. Patients use the Exact Sciences test of Wisconsin Madison, the house and those with positive results are invited to get a colonoscopy, which uses a small video camera at the end of a thin tube to view the colon, FDA said yesterday in a statement (Edney, 8/12).
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