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FDA approves more reliable at-home screening test for colon cancer

The US Food and Drug Administration last week approved a new at-home stool test to screen for colon cancer that’s better at detecting cancer than currently-used tests that check for hidden blood in the stool. Called Cologuard, it’s the first non-invasive test to detect the presence of DNA mutations, as well as blood, that could indicate cancerous growths or precancerous polyps.

In a head to head trial involving more than 10,000 patients, Cologuard accurately detected cancers and advanced adenomas more often than fecal immunochemical testing (FIT), which had been the most reliable stool test on the market.

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Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced adenomas, according to the FDA, compared to FIT’s 74 percent of cancers and 24 percent of advanced adenomas. Cologuard did, however, pick up more false abnormalities than FIT that turned out not to be cancer: 13 percent of the study participants who had Cologuard screening had a false positive result compared to 5 percent of those who had FIT.

Positive test results usually warrant a diagnostic colonoscopy to investigate and remove suspicious growths.

About one in three Americans fail to follow recommendations to get screened with colonoscopy every 10 years despite the fact that nearly 50,000 people in this country die of colon cancer every year, according to the US National Cancer Institute.

“It represents a significant step forward for noninvasive colorectal screening,” said Dr. Andrew Chan, a gastroenterologist at Massachusetts General Hospital. D.K.

Deborah Kotz can be reached at dkotz@globe.com. Follow her on Twitter @debkotz2.
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