Exact Sciences’ Cologuard Gets FDA Nod

by Brian Lee

A major milestone for Exact Sciences was achieved Monday, when the company announced its colorectal cancer screening test called Cologuard received approval from the U.S. Food and Drug Administration (FDA).

“The FDA approval of Cologuard represents a major achievement in Exact Sciences’ mission to make a noninvasive, patient-friendly screening test for colorectal cancer available,” CEO and Chairman Kevin Conroy said in a statement. “Cologuard addresses a critical need for a more convenient screening option for patients to aid in prevention and early detection.”

According to a release, Cologuard, which is available through healthcare providers for $599, is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers. It has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average-risk patients.

Exact Sciences also announced Monday that Cologuard is the first product to take part in the joint FDA and Centers for Medicare and Medicaid Services (CMS) parallel review pilot program in which both agencies simultaneously review medical devices to help reduce the time between FDA approval and Medicare coverage.