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ROCHESTER, Minn. -- The United States Preventive Services Task Force has issued its final colorectal cancer screening recommendations for 2016. The Task Force assigns an overall “A” grade to colorectal cancer (CRC) screening in people ages 50-75, and fully recommends several screening exams that now includes Cologuard, the stool DNA test codeveloped by Mayo Clinic and Exact Sciences.
“The task force decision to include Cologuard will make this accurate and noninvasive new colorectal cancer screening option available to millions of people who may be unable or unwilling to undergo colonoscopy,” says David Ahlquist, M.D., a gastroenterologist at Mayo Clinic and co-inventor of the test. “This decision will help save lives.”
The task force recommendations also recognize the use of Cologuard every three years, in keeping with the recommendation of the American Cancer Society and the coverage interval established by the Centers for Medicare and Medicaid Services.
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Colorectal cancer is the second leading cause of cancer death among men and women. According to the American Cancer Society, more than 134,000 people will develop colorectal cancer in 2016, and more than 49,000 will die of the disease.
In August 2014, Mayo Clinic became the first health care organization to offer Cologuard. The Cologuard technology platform was codeveloped by Exact Sciences Corp. and Mayo Clinic as part of a broad, exclusive collaboration.
Dr. Ahlquist and Mayo Clinic have a financial interest in Cologuard. Neither Mayo Clinic nor Dr. Ahlquist receives royalties for Cologuard tests ordered for Mayo Clinic patients by Mayo Clinic physicians.
About Exact Sciences
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, follow Exact Sciences on Twitter @ExactSciences, or on Facebook.
Cologuard was approved by the U.S. Food and Drug Administration in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society, and stool-DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Falsepositives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard,visit http://www.CologuardTest.com. Rx Only.
About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or https://newsnetwork.mayoclinic.org/.