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US FDA Approves At-Home Colorectal Cancer Screening Test

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Published on : Aug 12, 2014

The United States Food and Drug Administration (USFDA) has approved a new at-home screening test for colorectal cancer. The DNA-based test boasts 90% or higher accuracy. This approval was given after an FDA panel came to the unanimous decision, earlier in March 2014, that the benefits of the Cologuard test  - developed by Exact Science Corp.  - outweighed its risks.

With this approval, the patients and physicians have a more accessible option that will allow them to screen for colorectal cancer. According to senior FDA official Alberto Gutierrez, using fecal blood to test for colorectal cancer is a widely-used screening tool. The clinical data from the test showed that its rate of cancer detection was higher than other commonly-used fecal tests.

However, the U.S. Centers for Medicare & Medicaid Services said that they would undertake further reviews to gauge the potential for nationwide coverage of the Cologuard test. According to the agency’s proposal, the stool test should cover those who are in the age bracket of 50 to 85 years, do not have any colorectal disease symptoms, and face an average risk for this type of cancer.

In 2013, the number of new colorectal cancer cases that were diagnosed in the United States stood at nearly 143,000. About 50,000 deaths from colorectal cancer were reported in the U.S, said the U.S. National Cancer Institute.

In March 2013, the New England Journal of Medicine had published a study that found Cologuard showed high accuracy in finding colon cancer. The availability of a non-invasive test that is also accurate, would give more teeth to the fight against colon cancer, say experts.

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