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FDA approves DNA screening test for colon cancer

The US Food and Drug Administration on Monday 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 screening, which detected 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.

“This approval offers patients and physicians another option to screen for colorectal cancer,” said Alberto Gutierrez, FDA director of the Office of In Vitro Diagnostics and Radiological Health.

Other experts say it could offer a good option for those who are reluctant to get the more invasive screening colonscopy that requires a laxative prep to clean out the bowel and sedation during the procedure.

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. “This will probably replace FIT and with further studies it may replace screening colonoscopy.”

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