FDA: New Colorectal Cancer Screening Test Approved

Noninvasive Cologuard test has shown more than 90 percent accuracy in clinical trials

TUESDAY, Aug. 12, 2014 (HealthDay News) -- A screening test for colorectal cancer that can detect red blood cells and abnormal DNA in a person's stool has been approved by the U.S. Food and Drug Administration.

The noninvasive Cologuard test can be performed at home and has shown more than 90 percent accuracy in clinical trials, the agency said in a news release. From a stool sample, Cologuard detects hemoglobin. It also identifies certain genetic DNA mutations in cells shed by advanced adenomas. People who receive positive results should have a colonoscopy, the FDA advised.

Cologuard's approval does not change current guidelines that recommend colorectal screening using fecal occult blood testing, sigmoidoscopy, or colonoscopy for all adults aged 50 to 75, the agency added.

"This approval offers patients and physicians another option to screen for colorectal cancer," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in a statement. "Fecal blood testing is a well-established screening tool and the clinical data showed that the test detected more cancers than a commonly used fecal occult test."

Cologuard is produced by Exact Sciences of Madison, Wis.

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