Cologuard is highly sensitive in detecting colorectal cancer (CRC)

In a prospective, head-to-head, point-in-time, 90-site, pivotal study of 10,000 patients aged 50-84 at average risk, published in The New England Journal of Medicine, Cologuard demonstrated:*1


Cologuard is Highly Sensitive

in Detecting Colorectal Cancer (CRC)1

92% sensitivity in detecting CRC stages I to IV†1

94% sensitivity in detecting CRC stages I to II†1,2

87% specificity overall, excluding CRC and advanced adenomas‡1

99.94% negative predictive value

If a patient received a negative result, there was a 99.94% chance that there was no CRC§1

*In the pivotal study, screening colonoscopy was the reference method.1

Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).1,2

Cologuard specificity: 87% overall specificity, excluding CRC and advanced adenomas, and including all nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy. 90% specificity in participants with no lesions biopsied on colonoscopy.1

§Negative predictive value (NPV) is defined as the probability that disease is absent in those with a negative result; it is highly dependent on the prevalence of the disease. NPV was derived from the patient population evaluated in the Imperiale et al publication.1

REFERENCES 1. 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. 2. Ahlquist DA. Multi-target stool DNA test: a new high bar for noninvasive screening. Dig Dis Sci. 2015:60(3):623-633.