Cologuard: One Year Later

Today marks the one-year anniversary of Cologuard’s approval by the U.S. Food & Drug Administration and the proposed coverage memorandum by the Center for Medicare and Medicaid Services.

Thanks to researchers, physicians, advocacy organizations and our sales and marketing teams, we’re creating awareness about the importance of getting screened for colorectal cancer and highlighting Cologuard as a key option to do so.

As we celebrate Cologuard’s anniversary milestone, I want to a recap some of our achievements during the past year:

  • Groundbreaking FDA/CMS parallel review and approval—In August 2014, the FDA approved Cologuard and CMS issued a proposed coverage memorandum on the same day, making Cologuard the first product to complete the joint FDA and CMS parallel review program.
  • Changing care protocols—In November 2014, the American Cancer Society added Cologuard to its Colorectal Cancer Prevention and Early Detection national guidelines. 
  • Increasing access with health systems, insurers and providers—Providers including the Mayo Clinic, Meriter-UnityPoint Health, Mercy, MDVIP and Group Health Cooperative of South Central Wisconsin have signed on to offer Cologuard to patients in their care, among thousands of independent healthcare providers. Medicare, as well as private insurers Aetna Medicare Advantage, Anthem Blue Cross Blue Shield as well as several others, now cover Cologuard.
  • Industry recognition—Cologuard received numerous industry accolades including Popular Science magazine’s 2014 “Best of What’s New” award, a 2015 Edison Award and the American Business Award’s Stevie for Innovation of the Year.
  • Expanding innovation in cancer detection
    • Exact Sciences extended its work with the Mayo Clinic beyond Cologuard to begin developing tests that detect pancreatic and esophageal cancer at their earliest stages.
    • Exact Sciences is partnering with The University of Texas MD Anderson Cancer Center to develop and commercialize blood-based screening and diagnostic tests for the early detection of lung cancer.

More than 14,700 physicians ordered at least one Cologuard test since our October 2014 launch. These orders are having an impact in our effort to increase the screening population. According to a 3,000-patient survey by Exact Sciences, more than a third of Cologuard users (36 percent) had never been screened before.


Our customer care center, available 24/7 for patients and physicians, has also helped drive a Cologuard compliance rate of 73%.

The Exact Sciences team is both humbled by and excited about reaching so many lives by getting them screened for colorectal cancer. We thank our partners for their dedication to our mission this past year. Together, we are making a difference.

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. False positives 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 Rx Only.

Topics: Exact Sciences News

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