Best-in-class noninvasive detection1-4*  

Among USPSTF-recommended screening methods, the Cologuard® test delivers higher sensitivity than other noninvasive options, like the fecal immunochemical test (FIT). The Cologuard test delivers sensitivity and specificity in detecting advanced precancerous lesions, helping to identify colorectal cancer (CRC) early in eligible patients.1-5

Four healthcare providers having a discussion in a healthcare setting.
Peer-reviewed studies demonstrate the Cologuard test may result in improved outcomes and cost-effectiveness compared with FIT.6-8*  †
Cologuard Plus™ test data

Next-generation advanced sensitivity and specificity

Based on a subset of 18,911 average-risk patients aged 45-86 years from a prospective, multicenter study.1‡
Sensitivity
  • Overall CRC: 95%
  • High-grade dysplasia: 74%
  • Advanced precancerous lesions: 43%
Specificity
  • 94% when age-weighted to the US population with no colorectal neoplasia findings on colonoscopy
Sensitivity with the Cologuard Plus test was comparable to that of colonoscopy, which is 95% according to USPSTF review1,5

The Cologuard Plus test demonstrated superior sensitivity compared with FIT in detecting CRC, advanced precancerous polyps, sessile serrated polyps, and high-grade dysplasia.1,2

Cologuard Plus Clinician Brochure
Multitarget stool DNA test for CRC screening1
Study objective

To evaluate the safety and efficacy of the Cologuard Plus test as a screening test for the detection of markers associated with the presence of CRC and advanced precancerous lesions in a prospective, cross-sectional, multicenter, pivotal trial.

The primary performance measures were to determine the sensitivity of the Cologuard Plus test for CRC detection and for categories 3-6 (no advanced precancerous lesions or CRC). Secondary performance measures were to determine the sensitivity of the Cologuard Plus test for detection of advanced precancerous lesions, to compare sensitivities to FIT, and to evaluate the specificity of the Cologuard Plus test for participants with no colorectal neoplastic findings (category 6).

Study design

The study enrolled 26,758 average-risk, asymptomatic patients across 186 sites in the United States. Of the enrolled patients, 18,911 were included in the primary analysis population.

Patients provided stool samples (collected at home) for testing and underwent colonoscopy within 180 days of the sample collection. Results from the Cologuard Plus test and FIT were compared with the results of colonoscopy and histopathologic diagnosis of all significant lesions biopsied or removed. Patients and physicians were blinded to the results of the Cologuard Plus test and FIT.

Sensitivity calculations were performed using positive findings in categories 1 and 2 while specificity was calculated using categories 3-6. Stages of CRC were recorded based on the American Joint Committee on Cancer Staging System, 8th edition.

Reference

  1. Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
Chart showing Cologuard Plus demonstrated superior sensitivity compared with FIT in detecting CRR.
Cologuard test data

Superior overall sensitivity with the Cologuard test compared to FIT3,4

Demonstrated in a 2014 prospective, head-to-head, pivotal study of 10,000 patients aged 50-84 years at average risk for CRC, published in The New England Journal of Medicine.3,4
Sensitivity
  • 92% in detecting CRC stages I to IV
  • 94% in detecting early CRC stages I to II
Specificity
  • 87% overall
  • 90% in clean colonoscopy
The Cologuard test showed superior sensitivity to FIT† in detecting advanced precancerous polyps and CRC at all stages (I-IV).3,4
92% vs 74%
respectively (n=65; P=0.002)3,4
3X more
FIT† failed to detect 3x more total CRC findings (stages I to IV)3,4
87% specificity overall with the Cologuard test vs 95% with FIT.§

Effective detection of precancerous lesions

In the same pivotal study, the Cologuard test outperformed FIT† in detection of precancerous lesions, including high-grade dysplasia and sessile serrated polyps (secondary endpoints).3||
Chart supporting a study where Cologuard outperformed FIT in detection of precancerous lesions, including high-grade dysplasia and sessile serrated polyps (secondary endpoints).
Imperiale study design
Multitarget stool DNA testing for colorectal cancer screening1
Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. N Engl J Med. 2014;370(14):1287-1297
Study objective
To evaluate the multitarget stool DNA (mt-sDNA) test as a tool for screening. The primary aim was to determine the performance characteristics of the DNA test in the detection of CRC. The secondary aims were to determine the performance of the DNA test in the detection of advanced precancerous lesions and to compare it with a commercially available FIT for human hemoglobin in the detection of both CRC and advanced precancerous lesions.
Study design

From June 2011 through November 2012, participants were enrolled in this cross-sectional study at 90 sites throughout the United States and Canada, including private practice and academic settings. A total of 12,776 participants were enrolled at 90 sites; 9989 of these participants (78.2%) had results that could be fully evaluated.

The target population was asymptomatic persons between the ages of 50 and 84 years who were considered to be at average risk for CRC and who were scheduled to undergo screening colonoscopy. All participants were required to provide a stool specimen and undergo screening colonoscopy within 90 days after providing informed consent. Stool was collected before routine bowel preparation.

Colonoscopists were required to describe the extent of the examination, document cecal visualization, rate the quality of preparation and record the size and location of lesions. The biopsy and surgical specimens underwent histopathological analysis at the laboratory typically used by each study site. Polyps with high-grade dysplasia, as well as sessile serrated or hyperplastic polyps measuring 1 cm or larger were re-reviewed centrally by a gastrointestinal pathologist for confirmation.

Reference

  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.
High specificity in average-risk patients aged 45-499
In a separate study of 816 patients at average risk aged 45 to 49 years, the Cologuard test demonstrated 95.2% specificity in patients with nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy.9#
Five people in the age range of 45-49 in a discussion in an outdoor setting.
Learn how incorporating the Cologuard test may increase your system's screening rates
Health system experiences with the Cologuard test
Discover how your Electronic Health Record (EHR) can enable optimized workflows

Footnotes and references

  1. According to 3 peer-reviewed studies in commercial and Medicare populations.6-8
  2. OC FIT-CHEK, Polymedco, Inc.
  3. The Cologuard Plus test was evaluated in a prospective, multicenter study of 26,758 patients aged 40 to 84 years who were asymptomatic for CRC. Screening colonoscopy was the reference method.1,10
  4. 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 findings on colonoscopy and no histopathological review.3
  5. 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 (false negative). The clinical validation study was conducted in patients 50 years and older. Cologuard test performance in patients 45 to 49 years was estimated by sub-group analysis of near-age groups.3
  6. Advanced precancerous lesions included advanced adenomas and sessile serrated polyps measuring 1 cm or more in diameter.3
  7. Specificity was the primary outcome of the study and was measured in patients without CRC or advanced precancerous lesions and in the subgroup with negative colonoscopy findings. A secondary aim of the study was to determine the sensitivity of the Cologuard test for CRC and advanced precancerous lesions. The lack of CRC and low prevalence of advanced adenomas precluded precise estimation of Cologuard test sensitivity in this patient population. A second potential study limitation is selection bias, as persons enrolled in this study self-selected to complete screening colonoscopy. Study participants may not be representative of the average risk spectrum of adults ages 45 to 49 years of age.9

  1. Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
  2. Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. N Engl J Med. 2024;390(11):984-993.
  3. 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.
  4. Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
  5. Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977.
  6. Bhatt J, Chen JV, Vahdat V, et al. Cost-effectiveness of mt-sDNA versus mailed FIT outreach for Medicare Advantage enrollees using the CRC-AIM microsimulation model. J Clin Onc. 2022;40(16)(suppl):e18827.
  7. Fisher DA, Karlitz JJ, Jeyakumar S, et al. Real-world cost-effectiveness of stool-based colorectal cancer screening in a Medicare population. J Med Econ. 2021;24(1):654-664.
  8. Ebner D, Kisiel J, Barnieh L, et al. The cost-effectiveness of non-invasive stool-based colorectal cancer screening offerings from age 45 for a commercial and Medicare population. J Med Econ. 2023;26(1):1219-1226.
  9. Imperiale TF, Kisiel JB, Itzkowitz SH, et al. Specificity of the multi-target stool DNA test for colorectal cancer screening in average-risk 45-49 year-olds: a cross-sectional study. Cancer Prev Res (Phila). 2021;14(4):489-496.
  10. Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. Supplementary appendix. N Engl J Med. 2024;390(11):984-993.

Important Information about the Cologuard products


Indications for Use

The Cologuard® and Cologuard Plus™ tests are intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA)/advanced precancerous lesions (APL) and should be followed by a colonoscopy. The Cologuard test and Cologuard Plus test are indicated to screen adults of either sex, 45 years or older, who are at average risk for CRC. These tests are not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Contraindications

The Cologuard products are not for high-risk individuals, including patients who have the following:

  • a personal history of colorectal cancer and adenomas
  • a positive result from another colorectal cancer screening method within a test recommended timeframe
  • have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease
  • have a family history of colorectal cancer, or certain hereditary syndromes

Warnings and Precautions

All positive results should be referred to colonoscopy.

The Cologuard products may produce false positive and false negative results. A false positive result occurs when a result is positive, even though a colonoscopy will not find CRC or APL. A false negative result occurs when a result is negative, even when a colonoscopy identifies APL or CRC.

A negative result does not guarantee the absence of colorectal cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Performance when used for repeat testing has not been established.

Refer to the Cologuard test Clinician Brochure or the Cologuard Plus test Clinician Brochure for additional information about the benefits and risks of using each version of the Cologuard product for CRC screening.

Rx only.