DNA-Based Test that Measures Risk of Colon Cancer Approved by FDA

First Posted: Aug 12, 2014 12:58 PM EDT
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The U.S. Food and Drug Administration (FDA) recently approved a new at-home, DNA-based stool test that screens for colorectal cancer. Findings showed that the new tool carries a 90 percent accuracy rate.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, via Health Day. "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."

The recent decision was based on the fact that benefits of the study results seemed to outweigh any risks, according to Exact Sciences Corp.'s Cologuard.

The U.S. Centers for Medicare & Medicaid Services is proposing that the stool test be covered for people between the ages of 50-85 with no symptoms of colorectal disease and who are at average risk for colon cancer.

Statistics found that last year alone, colorectal cancer was diagnosed in 143,000 people. Almost 50,000 of those cases resulted in death, according to the U.S. National Cancer Institute.

As one of the more preventable cancers, researchers hope that with this tool, many become more knowledgeable regarding colorectal health and associated cancer risks.

More information regarding the findings can be seen via the New England journal of Medicine.

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