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FDA Advisers Recommend Approval of Colon Cancer Screening Tests — Physician’s First Watch

Medical News |
March 28, 2014

FDA Advisers Recommend Approval of Colon Cancer Screening Tests

By Kelly Young

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.

The FDA is not obligated to follow the guidance of its advisory committees, but it frequently does.

Reader Comments (2)

Rise Putzke Other Healthcare Professional, Infectious Disease, Retired

A 92% correlation is better than not having any test at all - the latter being what a significant minority of patients choose to do rather than have a colonoscopy.

MANUEL LOZANO Physician, Gastroenterology, Endoscopias Murcia ( private practique)

¿what about false negative test? they can produce one dangerous "security sense" in the patient

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