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FDA reviews DNA-based colon cancer screening kits

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The Food and Drug Administration is weighing the benefits and risks of two experimental colon cancer screening tests which use DNA from a patient’s stool to detect dangerous tumors and growths.

FDA scientists have questions about the accuracy and the potential real-world impact of the kits from Epigenomics and Exact Sciences, according to briefing documents posted online Monday. The agency released its reviews of the tests ahead of a two-day meeting that starts Wednesday.

Doctors have long used stool tests to look for hidden blood that can be a warning sign of tumors and precancerous polyps. Colon cancer is usually treatable if growths are detected and removed before they multiply and spread to other parts of the body.

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