Medicare Now Covers Stool DNA Screening Test Cologuard

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that Cologuard is now covered for Medicare patients based on a CMS National Coverage Decision. This is exciting news as most people who are already enrolled in Medicare will not face co-pays or co-insurance if they obtain a Cologuard kit. It is important to note…  Read More

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…  Read More

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…  Read More

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…  Read More