A large, prospective, observational study is under way to assess the real-world outcomes of individuals who use the at-home colorectal cancer (CRC) screening test Cologuard.1

Cologuard is currently the only at-home CRC screening test approved by the US Food and Drug Administration FDA and is indicated for the screening of individuals 45 years of age and older who are average risk for CRC. According to the company press release, 95% of patients who use Cologuard have no out-of-pocket costs for the test.

Previously, Cologuard was shown in a prospective study of nearly 10,000 patients to have a higher sensitivity but worse specificity than a fecal immunochemical test, and the results were reported in the New England Journal of Medicine.2

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Cologuard was found to have a 92% sensitivity for detecting colorectal cancer, 42% sensitivity for detecting advanced precancerous lesions, and 69% sensitivity for detecting polyps with high-grade dysplasia. However, the specificity rate was 87% for Cologuard, while a fecal immunochemical test had a 95% specificity rate.


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Known as Voyage, the study (ClinicalTrials.gov Identifier: NCT04124406) is being led by Mayo Clinic and is sponsored by Exact Sciences Corporation, the distributor of Cologuard. The goal of the study is to enroll 150,000 adults nationwide who are prescribed Cologuard for routine colon cancer screening and follow them for a minimum of 7 years. Outcomes that will be measured will include the proportion of patients having a diagnostic colonoscopy within 1 year after a positive Cologuard test and incidence of CRC compared with national rates of CRC.

According to the company press release, Voyage is “one of the largest prospective, observational colorectal cancer screening studies ever conducted.”

References

  1. Exact Sciences and Mayo Clinic initiate 150,000 patient, 7-year study to evaluate real-world impact of Cologuard®. Madison, WI: Exact Sciences Corporation; October 14, 2019. Accessed October 10, 2019.
  2. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370:1287-1297.