Exact Sciences, Mayo Clinic launch 150,000-strong Cologuard study

Since its FDA approval five years ago, Cologuard has helped screen more than 3 million people for colorectal cancer—with nearly half reporting that they had never been screened previously. (Exact Sciences)

Exact Sciences and the Mayo Clinic have launched a real-world study that aims to enroll at least 150,000 people to track the impact of the Cologuard colorectal cancer screening test as the company looks to establish it as the standard of care.

The seven-year clinical outcomes study aims to chart incidence and mortality rates nationwide among people with an average risk of cancer who have been prescribed and completed the at-home stool test. 

The prospective, observational study will also examine participants’ future use of healthcare services, including the number of people who go on to have a diagnostic colonoscopy within one year of a positive Cologuard test result. 


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Exact Sciences and Mayo described the trial as one of the largest colorectal cancer screening studies ever conducted. 

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"This study will be instrumental in further demonstrating the clinical utility of Cologuard, a highly accurate, non-invasive screening option, in our collective effort to reduce the colorectal cancer burden," Exact Sciences’ chief medical officer Paul Limburg said in a statement.

Since its FDA approval five years ago, Cologuard has helped screen more than 3 million people for colorectal cancer, according to Exact Sciences—with nearly half reporting that they had never been screened previously. 

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The company said Cologuard is 92% sensitive for detecting colorectal cancer and 69% sensitive for high-risk pre-cancers by searching for relevant DNA within stool samples. It was first validated in a prospective trial of 10,000 patients.

Exact Sciences and Mayo estimate that more than 50,000 people in the U.S. die from colorectal cancer each year and that 40% of the 106 million people eligible for screening aren’t being tested under the American Cancer Society’s guidelines.

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