Cologuard® is an FDA-approved, noninvasive multi-target stool DNA test for colorectal cancer screening.
The performance characteristics of Cologuard were established in a prospective, multi-site, point-in time study (NCT01397747) of average risk adults ages 50-84. 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% sensitivity 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.
*OC FIT-CHEK, Polymedco, Inc.
**Specificity is calculated excluding colorectal cancer and advanced adenomas.
Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.