FDA Approves First Colon cancer Screening Lab Test
My hope is that a simple screening test soon replaces colonoscopy or CT colonography, eliminating the discomfort, preparation and small risk of perforation.
As reported by the AMA daily email:
Bloomberg News (8/12, Edney) reports the FDA gave approval to Exact Sciences Corp. to sell “the first noninvasive DNA screening test for colorectal cancer that patients can use at home.” The article notes that the FDA “cleared Cologuard, which screens stool samples for the presence of red blood cells and DNA mutations that may indicate the presence of cancer.” The article notes that in a study, Cologuard “detected 92 percent of cancers and 42 percent of advanced precancerous growths, significantly more than an older test that looks only for blood in the stool.”
The AP (8/12, Perrone) notes that the new test, however, “was not superior on all counts.” The AP notes that Cologuard “was less accurate than older blood tests at correctly ruling out cancer, reporting more growths when none were actually present.”
The news was also covered by the Wall Street Journal (8/12, Walker, Subscription Publication), the St. Paul (MN) Pioneer Press (8/12), the Wisconsin State Journal (8/12), Medscape (8/12, Nelson) and HealthDay (8/12).