SENSITIVITY & SPECIFICITY
The Cologuard® test effectively detects colorectal cancer (CRC) and precancer as the 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, published in The New England Journal of Medicine, the Cologuard test demonstrated1*:
in detecting CRC stages I to IV1
in detecting early CRC stages I to II1-3†
overall1‡
in clean colonoscopy1‡
False positives and false negatives did occur in this pivotal study. 13% of patients without CRC 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 subgroup analysis of near-age groups.
The Cologuard test effectively detected advanced precancerous lesions1
Sensitivity for higher-risk types among advanced precancerous lesions
Sensitivity for advanced precancerous lesions according to size of largest lesion‖
The Cologuard test detected 69% of high-grade dysplasia vs 46% with FIT.1
The Cologuard test is an effective screening option that may help you rule out CRC1
of Cologuard patients tested negative
In clinical practice, these patients would not need to undergo a screening colonoscopy1¶
negative predictive value (NPV)
With a negative result, there was a 99.94% chance that a patient would not have CRC1¶
Reliable results with the Cologuard test1
Watch to find out how the Cologuard test helps determine if eligible patients need a colonoscopy and provides reassurance through negative results.
View more Cologuard data
Find out how the Cologuard test impacts adherence to CRC screening.
The Cologuard Clinician Brochure details the clinical data and complete prescribing information for the Cologuard test.
The Cologuard test vs FIT
Learn how the Cologuard test compares with another noninvasive CRC screening option in performance and the detection of biomarkers| * | In the pivotal study, screening colonoscopy was the reference method.1 |
| † | Statistic calculated using data from the pivotal study and reported within the Ahlquist review article. Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).2,3 |
| ‡ | Cologuard specificity: 87% overall specificity, excluding CRC and advanced adenomas, and including all nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy. There was 90% specificity in participants with no lesions biopsied on colonoscopy.1 |
| § | OC FIT-CHEK, Polymedco, Inc. |
| ‖ | P value for trend: multitarget DNA test, P<0.001 FIT, P<0.001.1 |
| ¶ | 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 lmperiale et al publication.1 |