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FDA Approves At-Home DNA Test for Colon Cancer

Human intestines

The U.S. Food and Drug Administration has approved a new DNA-based screening test for colon cancer that has 90 percent accuracy and can be taken at home.

Called Cologuard and manufactured by Exact Sciences Inc., the test is the first of its kind to get an OK from federal regulators.

The test uses a stool sample to detect the presence of blood and DNA mutations that may indicate cancerous and precancerous growths in the colon. A doctor's prescription is needed, but the stool sample is collected at home and sent to a laboratory for analysis. Patients with positive test results are advised to have a diagnostic colonoscopy.

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The test "offers patients and physicians another option to screen for colorectal cancer," Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said in an agency press announcement. "Fecal blood testing is a well-established screening tool," and the clinical data showed that the DNA-based test detected more cancers than did a commonly used fecal sampling test, Gutierrez said.

In another first, the Centers for Medicare and Medicaid Services (CMS) are also considering providing reimbursement for taking the Cologuard test once every three years for people ages 50 through 85 who have no symptoms of colorectal disease, or who are at average risk for colon cancer.

"This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day," Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS, said in the FDA announcement.

Colon cancer primarily affects people 50 or older and is the second leading cause of cancer-related death in the United States, according to the Centers for Disease Control and Prevention (CDC). The American Cancer Society estimates that this year there will be nearly 137,000 new cases of colorectal cancer and more than 50,000 deaths.

In a study of 10,023 subjects comparing Cologuard to a current fecal sampling test, Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced polyps, while the standard screening test detected 74 percent of cancers and 24 percent of advanced polyps. Cologuard, however, had more false positives than the standard test, according to findings published in the New England Journal of Medicine.

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While a colonoscopy is still the gold standard for detecting colon cancer, one in three American adults are still not being screened. The introduction of a noninvasive, at-home test with highly accurate results could result in more Americans getting tested. The CDC estimates that if everyone 50 or older got screened, at least 60 percent of colorectal cancer deaths could be avoided.

"The main goal of the test is to get more people screened than are currently being screened," Exact Sciences CEO Kevin Conroy told the Wall Street Journal. Patients with private insurance will be charged $599 for the Cologuard test, Conroy said; the company has proposed selling the test to Medicare patients for $502.

Photo: eraxion/iStock


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