Through high sensitivity, Cologuard® effectively detects CRC and precancer as a best-in-class, noninvasive screening option1

In a 2014, prospective, head-to-head, point-in-time, 90-site, pivotal study of 10,000 patients aged 50 to 84 years at average risk for CRC, the primary endpoint was the ability of Cologuard to detect CRC (all stages). Published in the The New England Journal of Medicine, Cologuard demonstrated1*:


Sensitivity overall
in detecting CRC
stages I to IV1
Sensitivity in
early CRC
in detecting CRC
stages I to II1-3†


Specificity overall
in patients with
nonadvanced adenomas,
nonneoplastic findings,
and negative colonoscopy
Specificity in
clean colonoscopy,
defined as 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). 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.

Through high sensitivity, Cologuard demonstrated effective detection of both CRC and advanced precancerous lesions.1

Higher-risk types among
advanced precancerous lesions

Advanced precancerous lesions
according to size of largest lesion§

Cologuard detected 69% of high-grade dysplasia in patients vs 46% with FIT.1||

Cologuard is an effective screening option that may help you rule out CRC1

Cologuard patients tested negative
In clinical practice, these patients would not need to undergo a screening colonoscopy
Negative predictive value
If a patient received a negative result, there was a 99.94% chance that there would be no CRC1

Trust Cologuard to rule out CRC in your eligible patients.