Dr. Weeks’ Comment: FDA finally approved Exact Sciences stool noninvasive colorectal cancer screening test:
FDA Approves Exact Sciences’ Cologuard®; First and Only Stool DNA Noninvasive Colorectal Cancer Screening Test
First time in history a technology receives FDA approval and proposed national coverage by CMS on the same day
Screening test detects 92% of colorectal cancer
MADISON, Wis., August 12, 2014 / PR Newswire / ”” Exact Sciences Corp.(NASDAQ: EXAS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company’s noninvasive, stool DNA colorectal cancer screening test. Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients. Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy-to-use screening test they can do in the privacy of their own home.