Cologuard is intended to screen adults aged 45 years and older at average risk for colorectal cancer (CRC).
Through high sensitivity, Cologuard effectively detects CRC and precancer as a best-in-class, noninvasive screening option1
In a 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, published in The New England Journal of Medicine, Cologuard demonstrated1*:
stages I to IV1
stages I to II1-3†
and negative colonoscopy
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.