Mayo-backed colon screening test gets FDA approval

Published 10:16 am Tuesday, August 12, 2014

By Christopher Snowbeck

St. Paul Pioneer Press

The Food and Drug Administration on Monday announced approval for Cologuard, a new test kit developed in part at the Mayo Clinic for screening patients to assess their risk for colorectal cancer.

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In a related announcement Monday, the federal Centers for Medicare and Medicaid Services proposed that the federal Medicare cover costs for the new test.

Colorectal cancer primarily affects people age 50 and older and is one of the most common causes of cancer-related death.

“This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day,” said Patrick Conway, chief medical officer with the federal Centers for Medicare and Medicaid Services, or CMS, in a statement.

“Parallel review allows the last part of the FDA process to run at the same time as the CMS process, cutting as many as six months from the time from study initiation to coverage,” said Nancy Stade, an FDA official, in a statement.

Cologuard is manufactured by Exact Sciences of Madison, Wisconsin.

In March, Mayo Clinic announced results of a large clinical trial showing Cologuard was about as effective as a colonoscopy in detecting problems. The test uses a patient’s stool sample and analyzes it for DNA signatures of precancer or cancer, according to a news release from the clinic.

Patients with positive test results are advised to undergo a diagnostic colonoscopy procedure.

In its announcement Monday, FDA noted that stool DNA testing is not currently recommended as a method to screen for colorectal cancer by the U.S. Preventive Services Task Force. The task force recommends adults age 50 to 75 at average risk for colon cancer receive fecal occult blood testing, sigmoidoscopy or colonoscopy.

But with the coverage proposal announced Monday, Medicare would pay for patients to undergo the Cologuard test once every three years under certain conditions.

Dr. David Ahlquist, a gastroenterologist at Mayo, is co-inventor of the test. Mayo Clinic is an equity investor in Exact Sciences.

—Distributed by MCT Information Services