Mayo Clinic is First Health System to Offer Cologuard Home-Based Colon Cancer Test

The world-renowned Rochester, Minn.-based Mayo Clinic will be the first health system to offer Cologuard from Exact Sciences Corp., the first and only Food and Drug Administration (FDA)-approved, non-invasive stool DNA screening test for colorectal cancer.
Cologuard will be available to patients through their primary care physicians at Mayo Clinic.

Available by prescription only, Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy to use screening test which they can do in the privacy of their own home. The company claims the product is the first non-invasive screening test for colorectal cancer that analyzes both stool-based DNA and blood biomarkers to detect cancer and pre-cancer. The Cologuard technology platform was co-developed by Exact Sciences Corp. and Mayo Clinic as part of a broad, exclusive collaboration.

“Cologuard represents a significant advancement in identifying colorectal cancer at its most treatable stage. We believe offering this new tool will promote patient and community public health and may move more patients to get screened earlier—a critical step in beating this prevalent and preventable cancer,” said Vijay Shah, M.D., chair of Mayo Clinic gastroenterology and hepatology.

Colorectal cancer is highly preventable with screening. However, 23 million Americans between 50 and 75 years old are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cancer killer in the United States. For those whose cancer is detected at an earlier stage, the five-year survival rate can be greater than 90 percent.

“Mayo Clinic’s adoption of Cologuard marks a significant step forward in providing patients access to this important new cancer screening technology,” said Kevin Conroy, president, CEO and chairman of Exact Sciences Corp. “We look forward to continuing our collaboration with the Mayo Clinic to develop a growing pipeline of diagnostic screening innovations for GI (gastrointestinal) tract cancers.”

Cologuard is designed to detect DNA alternations and blood released from cancer and precancerous colon lesions. The test requires a physician order. After the physician orders Cologuard, the kit is mailed directly to the patient’s home. The patient then collects a stool sample in the Cologuard Collection Kit and sends the kit back to the Exact Sciences lab for testing through a pre-paid mailer.
Patients learn of their results in as little as two weeks from their physician. Patients with a positive result will need to undergo colonoscopy.

“Low screening rates have long contributed to low survival rates for colorectal cancer, with more than 60 percent of all cases not detected until late stages of the disease,” said David Ahlquist, M.D., a Mayo Clinic gastroenterologist and co-inventor of the test. “I am hopeful that the test’s efficacy and convenience will result in improved detection and survival rates for colorectal cancer.”

Ahlquist, M.D., is a co-inventor of the technology that has been licensed to Exact Sciences from Mayo Clinic. Under that licensing agreement, Mayo Clinic and Ahlquist share in equity and royalties. Revenue Mayo Clinic receives is used to support its not-for-profit mission in patient care, education and research.

Madison, Wis.-based Exact Sciences is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer.