Cologuard had received recommendation for premarket approval from a FDA advisory panel back in March.
The US Food and Drug Administration (FDA) today approved Cologuard (Exact Sciences Corporation), a stool-based colorectal cancer (CRC) in vitro diagnostic device.
Cologuard analyzes stool specimens to detect hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA contained in cells that are shed by CRC or advanced adenomas into the colon.
The test is intended to be used as an adjunctive screening test to detect colorectal neoplasia-associated DNA markers and the presence of occult hemoglobin in human stool. A positive test result may indicate the presence of CRC or premalignant colorectal neoplasia. The device is not meant to be a replacement for colonoscopy and is intended to be used in conjunction with colonoscopy and other test methods according to recognized screening guidelines.
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