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WASHINGTON -- The first-ever DNA-based screening test for colorectal cancer has received FDA approval and preliminary approval for Medicare coverage of the test.

The Cologuard test detects hemoglobin and mutant DNA in cells sloughed into stool by cancers and adenomatous polyps. A positive test indicates a need for colonoscopy to identify or rule out colon cancer.

At the same time, the Centers for Medicare and Medicaid Services (CMS) issued a proposal to cover the DNA test, a first for the two regulatory agencies.

"This approval offers patients and physicians another option to screen for colorectal cancer," , director of FDA's office of in vitro diagnostics 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."

The clinical data cited by Gutierrez came from a 10,000-patient comparison of the DNA test and the fecal immunochemical test (FIT). Stool specimens from the patients were evaluated by FIT and the DNA test, and all patients underwent colonoscopy to determine the presence or absence of cancer or polyps.

The results showed that the DNA test detected 92% of colon cancers and 42% of advanced adenomas, as compared with 74% and 24% for FIT. The fecal occult blood test did have a higher specificity, correctly ruling out colon lesions 95% of the time versus 87% for the DNA test.

The CMS proposal calls for coverage of the DNA test once every 3 years for beneficiaries who meet specific criteria: ages 50 to 85, asymptomatic (including negative FIT or guaiac fecal occult blood test), and average risk of colorectal cancer.

The occurred as part of a pilot program to expedite FDA and CMS action on selected devices submitted for premarket approval.

"This is the first time in history that FDA has approved a technology and CMS has proposed national coverage in the same day," , CMS chief medical officer, said in a statement. "This parallel review represents unprecedented collaboration between the two agencies and industry and, most importantly, will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer."

Cologuard is manufactured by Exact Sciences in Madison, Wis.

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