FDA Advisers Recommend Approval of New Colon Cancer Screening Tests

A panel of FDA advisers voted unanimously in favor of recommending 
approval of the Cologuard device for colorectal cancer screening. It 
is designed to test patients’ stool for hemoglobin, DNA methylation 
and mutation markers, and total amount of DNA, according to Reuters.

In addition, the group narrowly recommended approval of Epi proColon 
— a blood test for colorectal cancer — the Associated Press 
reports. The panel voted 5 to 4 that the benefits of the test 
outweighed the risks in people of average cancer risk. Epi proColon 
measures plasma levels of methylated Septin 9 DNA, which has been 
associated with colorectal cancer.

Patients who screen positive for either test would be referred for 
colonoscopy.

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