Clarification: Panel Approves Cologuard (not the FDA)


Kim Ryan delivers comments to the FDA panel

Fight Colorectal Cancer submitted public comments to the FDA last week regarding new colorectal cancer screening tests, including Cologuard by Exact Sciences and Epi proColon by epigenomics. (Read comments here.)

Cologuard Update

As a result of the advisory committee meeting, an FDA panel voted 10-0 to recommend that the FDA approve Cologuard. Cologuard is a stool-based screening test that looks for DNA in a patient’s stool that may detect genetic changes associated with cancer cells in the colon or rectum. A positive result from this test would lead patients to diagnostic colonoscopy.

In this case, as we commented on new screening technologies we kept the following considerations in mind:

1) The new screening tools add options and resources for use with, or in combination, with already existing tests (ex. a positive Cologuard test would require colonoscopy.)
2) The new screening tests address patient-reported barriers to compliance
3) Noninvasive screening tests are an important option for colorectal cancer screening

This is good news for patients,” said Anjee Davis, president of Fight Colorectal Cancer. “Providing that the FDA takes the recommendation of the panel and approves Cologuard as a new, novel screening tool, average-risk patients will have another option when it comes to deciding how to be screened for colorectal cancer.”

The approval of Cologuard and additional testing options for patients have the potential of assisting in increased outreach efforts to reach 80 percent of people needing to be screened for colorectal cancer by 2018.

Epi proColon Update

The panel’s vote on the Epi proColon test was a little different. Although the majority of the panel felt as though the blood test was safe, the panel decision regarding efficacy was split down the middle, as was the vote on the benefits of the test outweighing the risks. So now, it will be up to the FDA to look at the recommendations of the panel and decide if the product warrants approval, or if additional data or information is needed or required.

It’s important to know the FDA has NOT approved either one of these tests yet.

The recommendations last week came from the advisory committee’s panel, that listened to comments from both the sponsors (epigenomics and Exact Sciences) and the FDA. The panel also listened to public hearing comments, which we took part in. Fight Colorectal Cancer will continue to monitor both test’s potential approval and subsequent availability.


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Disclaimer:  Fight Colorectal Cancer believes in fully disclosing any conflicts of interest. We have worked with and received unrestricted funding from many companies who have an interest in existing and novel screening methods for colorectal cancer, including Quest Diagnostics, Exact Sciences, and epigenomics. None of these companies, nor any of our other corporate supporters, have influenced our comments on this issue.

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