FDA Approves First Noninvasive Colorectal Cancer Test

August 13, 2014 9:16 PM

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FDA Approves First Noninvasive Colorectal Cancer Test

Exact Sciences has won FDA approval for the first noninvasive DNA screening test for colorectal cancer—the first stool-based diagnostic designed to indicate the presence of abnormal growths in red blood cells and DNA mutations, and the first test to be approved under a joint parallel review pilot program by the agency and the Centers for Medicare and Medicaid Services (CMS).

Cologuard® is designed to analyze both stool DNA and blood biomarkers, and is intended for at-home use by adults 50 years old and older. The test has been proven to find 92% of cancers and 69% of the most advanced precancerous polyps in average risk patients, according to Exact Sciences.

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