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*:

Sensitivity
92%

in detecting CRC stages I to IV1

94%

in detecting early CRC stages I to II1-3†

Specificity
87%

overall1‡

90%

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 lesions (APLs)1

Sensitivity for higher-risk types among APLs

Vertical bar chart with the Cologuard test and FIT's sensitivity to detecting high-grade dysplasia and sessile serrated polyp.

Sensitivity for APLs according to size of largest lesion‖

Vertical bar chart with the Cologuard test and FIT's sensitivity to detecting advanced precancerous lesions according to different sizes.

The Cologuard test detected 69% of high-grade dysplasia vs 46% with FIT.1

The Cologuard test detected >623,000 instances of cancer and APLs over the past 10 years.4¶

Through APL detection and subsequent removal during follow-up colonoscopy, it is estimated that the Cologuard test may have prevented CRC in over 39,000 people.4

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

84%

of Cologuard patients tested negative

In clinical practice, these patients would not need to undergo a screening colonoscopy1#

99.94%

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.

The Cologuard test analyzes patient stool for the presence of 11 biomarkers, including hemoglobin and DNA markers, that are associated with colorectal cancer and advanced adenomas.1

  • 1Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.​

Read the Cologuard Clinician Brochure

In a clinical study, the Cologuard test had 92% sensitivity in detecting colorectal cancer in stages I to IV and 94% sensitivity in detecting colorectal cancer in stages I to II.1-3*


In a clinical study of patients aged 50 to 84 years, the Cologuard test had an 87% specificity overall, excluding colorectal cancer and advanced adenomas, and including all nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy. There was 90% specificity in participants with no findings on colonoscopy and no histopathological review.1


False positives and false negatives do occur. In a clinical 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). This clinical validation study was conducted in patients 50 years of age and older.


The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients aged 45 to 49 years was estimated by subgroup analysis of near-age groups.

  • *Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).1
  • 1lmperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
  • 2Ahlquist DA. Multi-target stool DNA test: a new high bar for noninvasive screening. Dig Dis Sci. 2015;60(3):623-633.
  • 3 Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.

Cologuard box.

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Find out how the Cologuard test impacts adherence to CRC screening.

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The Cologuard Clinician Brochure details the clinical data and complete prescribing information for the Cologuard test.

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The Cologuard test vs FIT

Learn how the Cologuard test compares with another noninvasive CRC screening option in performance and the detection of biomarkers

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* 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
Based on a simulated analysis that assessed the effectiveness of CRC screening with the Cologuard test. Previously published data were used for APL prevalence rates, cancer prevalence rates by stage, transition rate of APL into CRC in the average-risk population, and Cologuard sensitivity and specificity.4
# 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