Cologuard® is an FDA-approved, noninvasive stool DNA test for colorectal cancer screening.
The performance characteristics of Cologuard were established in our prospective, multi-site, 10,000-patient, point-in time study (NCT01397747). The study compared the performance of Cologuard to a leading fecal immunochemical test*, a commonly used noninvasive colorectal cancer screening test. The study took place at 90 centers throughout the U.S. and Canada.
Some highlights published in the New England Journal of Medicine are below:
- 92% sensitivy in detecting colorectal cancers (stages I-IV) compared to 74% for a leading FIT*;
- 94% sensitivity in detecting colorectal cancers in early stages (stages I-II);
- 87% specificity** overall, including all nonadvanced adenomas.