- FDA approved Exact Sciences’ Cologuard, its new stool-based DNA screening test for colorectal cancer.
- In my original article I anticipated that FDA will approve Cologuard sometimes in 2014 or early 2015.
- The news confirms my bull thesis on Exact Sciences.
Exact Sciences (NASDAQ:EXAS) has bagged FDA approval for its new stool-based DNA screening test, known as Cologuard, for colorectal cancer. Upon approval, Exact Sciences instantly received a proposed coverage from the Centers for Medicare and Medicaid Services ("CMS"). Cologuard was the first product that took part in the joint FDA and CMS parallel review pilot program.
The company will now offer the Cologuard test to U.S. healthcare providers for $599. Exact Sciences CEO Kevin Conroy told FierceMedicalDevices that the company is planning to work with private insurers to issue coverage decisions for Cologuard and to make its screening test available to more patients over the age of 50 who are at average risk of colorectal cancer.
In my original analysis I said that I strongly believe that Cologuard would be cleared eventually due to its technological superiority to existing diagnostic methods, such as FOBT (fecal occult blood test) and FIT (fecal immunochemical test). Cologuard has tremendous potential in detecting colorectal cancer. Since all colorectal cancers start as polyps and the cancer develops over many years, if people take the Cologuard test every three years, most polyps would be detected before they could cause problems.