Exact Sciences’ Cologuard wins FDA approval

Aug. 12--Big news came late Monday for Exact Sciences Corp.: The U.S. Food and Drug Administration has approved Cologuard, the Madison company's non-invasive test to screen for colorectal cancer.

"This is the culmination of almost two decades of work. I can't tell you how exciting it is for the company, for all of the people who have helped make this a reality, including researchers from Mayo Clinic," Exact Sciences chief executive Kevin Conroy said as he boarded a flight to New York for an expected early morning broadcast appearance.

Cologuard, a DNA-based stool test, will be indicated for people ages 50 and older who are considered at average risk for colorectal cancer.

The test detects hemoglobin, a protein found in blood, and certain DNA mutations associated with colorectal cancer. Patients who test positive are advised to undergo a colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," Alberto Gutierrez, director of the FDA'sOffice of in Vitro Diagnostics and Radiological Health, said in a news release.

Research analyst Jeffrey Elliott, of Robert W. Baird & Co., welcomed the news.

"Importantly, we believe the approval language clearly positions Cologuard as a primary screening option, rather than a secondary option (e.g., for use only if colonoscopy is refused)," Elliott wrote in a research note late Monday.

The Centers for Medicare & Medicaid Services (CMS) issued a preliminary decision on covering the cost of the test, proposing a three-year testing interval for people ages 50 to 85 with no cancer symptoms. The proposal is subject to a 30-day comment period and final action is expected in November.

This is the first time CMS has proposed national coverage on the same day the FDA approved a technology, said Patrick Conway, CMS chief medical officer.

Conroy said Cologuard will be available for physicians to order from Exact Sciences' website, www.exactsciences.com. Kits will be shipped directly to patients, starting Sept. 2, Conroy said. The cost: $599.

"We'll start working with insurance companies, starting tomorrow," he said.

Publicly traded Exact Sciences has 300 employees, about 200 of them in Madison, with headquarters in University Research Park, at 441 Charmany Drive, and a new lab in the Novation Campus, off Rimrock Road</location>.

Colorectal cancer is the third-most-common cancer affecting both men and women and the No. 2 cause of cancer-related death in the U.S., according to the Centers for Disease Control and Prevention.

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