The approval has the potential to reshuffle current medical practice, though FDA officials stressed Monday that DNA-based stool screening has not been endorsed by federal medical advisers who set screening guidelines. A spokeswoman for Exact Sciences, which is based in Madison, Wisconsin, said the new test would cost $599 per patient. That compares to about $25 for a traditional stool blood test.
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Exact Sciences' CEO Kevin Conroy said that Cologuard's cost is justified considering that the U.S. spends over $14 billion annually treating cases of colon cancer that go undetected.
"We think, from a cost perspective, Cologuard represents a dramatic shift toward quality at a reasonable cost," Conroy said in an interview. "There's really no comparison between Cologuard and the current stool blood test."
Current federal guidelines recommend traditional stool tests every year and a colonoscopy every 10 years for patients between ages 50 and 75. Colonoscopy is the most accurate method for spotting colon cancer but many adults are reluctant to undergo the invasive procedure, which requires sedation as doctors probe the colon with a camera-fitted endoscope.