High sensitivity in a noninvasive colorectal cancer (CRC) screening test1

In a prospective, head-to-head, point-in-time, 90-site, pivotal study of 10,000 patients aged 50-84 years at average risk for CRC, published in The New England Journal of Medicine, Cologuard demonstrated1*:


Sensitivity overall

in detecting CRC
stages I to IV1†


Specificity overall

in patients with nonadvanced adenomas, nonneoplastic findings, or negative colonoscopy results1‡

Sensitivity in early CRC

in detecting CRC
stages I to II1,2†

Specificity in clean colonoscopy

in patients who had a totally negative colonoscopy result1‡

False positives and false negatives did occur in this pivotal study. 13% of patients without colorectal cancer or advanced adenomas received a positive result (false positive), and 8% of patients with cancer received a negative result (false negative). Cologuard performance when used for repeat testing has not been evaluated or established. The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

Cologuard is a highly effective test that
may help you rule out CRC

If a patient received a negative test result, there was a 99.94% chance that there was no CRC.