Tag Archives: Epi proColon

Clarification: Panel Approves Cologuard (not the FDA)

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)

Comments on New DNA & Stool-Based Screening Tests to FDA

This week Fight Colorectal Cancer is providing comments to the FDA as they consider two new screening technologies for colorectal cancer. Below are our opinions and recommendations presented to the Molecular and Clinical Genetics Panel as part of the Medical Devices Advisory Committee. Background: This week, the Food & Drug Administration (FDA) is hosting an advisory committee meeting with many stakeholders that have an interest in two new potential screening technologies, Epi proColon (by Epigenomics) and Cologuard (by Exact Sciences). Kim Ryan, our Director of Patient Information Services and advocate Marcia Mullins are attending to provide comments as the FDA considers these two new screening technologies.   About Epi proColon & Cologuard

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