Tag Archives: cologuard

FDA approves first non-invasive DNA test for colorectal cancer

Big news in the colorectal cancer prevention and screening community yesterday! In a never-before-seen move, the Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly proposed Cologuard as a new option for colorectal cancer screening. What is Cologuard? Cologuard, produced by Exact Sciences, is a non-invasive (not requiring insertion of instruments into the body), stool-based (you test your poo) DNA test designed to analyze the presence of blood and certain DNA mutations in a patient’s stool sample that can indicate cancer and/or precancerous polyps. Cells of DNA are released into the stool continuously as part of the digestive process. There are already at-home screening options

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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