Highly Accurate Home Test for Colon Cancer Approved by FDA
Nikki Alfonso | | Aug 13, 2014 02:22 AM EDT |
Prototype Cologuard kit
The U.S. Food and Drug Administration (FDA) has approved a home, non-invasive DNA-based stool test that can detect colon cancer.
The test is more than 90 percent accurate.
The approval of the test called "Cologuard" comes after an FDA panel voted unanimously that the benefits of the test outweighs the risks that come with it.
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The test gives patients and physicians another way of screening for colon cancer aside from a painful session of colonoscopy, said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health.
Patients are, however, encouraged to undergo colonocospies to make certain they have colon cancer.
Doctors recommend that individuals 50 years of age and above undergo colonoscopies every 10 years.
"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 (blood) test," said Gutierrez.
While the FDA has approved the test, the U.S. Centers for Medicare & Medicaid Services (CMS) is currently reviewing Cologuard test's efficacy.
If they find the test is truly accurate, CMS will push that the test be part of the health coverage of individuals aged 50 to 85 who have no symptoms of colon cancer and are at average risk for the disease.
Having the FDA approve the test and having CMS proposing national coverage for the test on the same day is historic, said Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS.
The test's more than 90 percent efficacy "is really unprecedented for a noninvasive stool-based screening," noted Dr. Steven Itzkowitz, director of the gastroenterology fellowship program at the Icahn School of Medicine at Mount Sinai.
Wisconsin-based Exact Sciences Corporation funded research for the test.
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