Your trusted noninvasive just got better1,4
Based on a subset of 18,911 average-risk patients aged 45-84 years from a prospective, multicenter study.1*
SENSITIVITY & SPECIFICITY
Cologuard® first. Colonoscopy as needed.
For average-risk patients 45 and older, offering the Cologuard test first can help get more patients screened.1-3
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Cologuard Plus™
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Cologuard
Sensitivity (rate of true positives)
95%
Stages I to IV1
95% of adults with CRC tested positive
Specificity (rate of true negatives)
94%
No colorectal neoplasia1†
94% of adults without precancerous polyps or CRC tested negative
Age-weighted to the US population.1
False positives and negatives do occur. Out of every 100 patients testing positive, approximately 3 patients will have CRC, 34 patients will have APLs, 33 will have nonadvanced adenoma, and 30 will have no neoplastic findings. Out of every 100 patients testing negative, approximately 7 patients will be falsely assured that they do not have APLs.
Cologuard Plus CRC sensitivity is comparable to colonoscopy (95% according to the USPSTF).1,5‡
High specificity means fewer unnecessary colonoscopies for your patients.1
Sensitivity
100%
Stages I to IV1
100% of adults aged 45-59 years with CRC tested positive
Specificity
94%
No advanced colorectal neoplasia1
94% of adults aged 45-59 without precancerous polyps or CRC tested negative
All patients who had CRC in this age group received a true positive, with 20/20 cancers detected.1
Consistent screening every 3 years with the Cologuard Plus test can detect CRC and precancer earlier when treatment is most effective.1,7,9
The Cologuard Plus test may help prevent CRC by detecting precancer and through high patient adherence to follow-up colonoscopy after a positive result1,10-12
FDA-approved to detect precancer.1
Through precancer detection, the Cologuard Plus test is predicted to help reduce the number of CRC cases.1,13,14
73%
Reduction in CRC cases across average-risk Americans aged 45-85 years13,14§
Predicted outcomes by the CRC-SPIN model by the USPSTF when adherence for stool DNA testing was assumed at 100%.
The Cologuard Plus test detected:
- ~2x more advanced precancerous lesions than FIT1||¶
- ~10x more sessile serrated lesions than FIT1||#
Providers have been compensated for sharing their expertise and for acting as consultants for Exact Sciences.
86.8%
of Cologuard Plus patients tested negative
In clinical practice, these patients would not need to undergo a colonoscopy1
99.9%
Negative predictive value (NPV) for CRC
With a negative result, there was 99.9% certainty that a patient would not have CRC1**
93.2%
NPV for CRC and precancerous polyps
With a negative result, there was 93.2% certainty that a patient would not have CRC or advanced precancer1 **
Patients who receive a negative Cologuard Plus result do not need a colonoscopy.
Offer the Cologuard Plus test to average-risk patients as defined by the USPSTF and prioritize colonoscopy for those who need it most.1,5
The Cologuard Plus Clinician Brochure details the clinical data and complete prescribing information for the Cologuard Plus test.
The Cologuard test has been trusted for 10+ years15
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, the Cologuard test demonstrated2*:
Sensitivity (rate of true positives)
92%
Stages I to IV2
92% of adults with CRC tested positive
94%
Stages I to II2,16,17††
94% of adults with early-stage CRC tested positive
Specificity (rate of true negatives)
87%
overall2‡‡
87% of adults without CRC and APLs tested negative
90%
in clean colonoscopy2‡‡
90% of adults with negative colonoscopies tested negative
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.
Higher performance in younger patients16
Effective detection in a subgroup analysis of adults younger than 60 years.16
Sensitivity (rate of true positives)
100%
Stages I to IV
100% of adults younger than 60 years with CRC tested positive16
Specificity (rate of true negatives)
92%
Overall
92% of adults aged 50-59 without precancerous polyps to CRC tested negative16
All patients who had CRC in this age group received a true positive, with 7/7 cancers detected.16
The Cologuard test detected >623,000 instances of cancer and APLs over the past 10 years.15,18§§
Through APL detection and subsequent removal during follow-up colonoscopy, it is estimated that the Cologuard test may have helped prevent CRC in over 39,000 people.18
Provider has been compensated for sharing their expertise and for acting as a consultant for Exact Sciences.
Precancer detection leads to cancer prevention6
Consistent screening every 3 years with the Cologuard test can detect CRC and precancer earlier when treatment is most effective.7,9,16
FDA-approved to detect precancer.2
Through precancer detection, the Cologuard test is predicted to help reduce the number of CRC cases.2,13,14
73%
Reduction in CRC cases across average-risk Americans aged 45-85 years13,14§
Predicted outcomes by the CRC-SPIN model by the USPSTF when adherence for stool DNA testing was assumed at 100%.
The Cologuard test effectively detected advanced precancerous lesions2
The Cologuard test detected:
- ~2x more advanced precancerous lesions than FIT16||||¶¶
- ~9x more sessile serrated lesions than FIT16||##
The Cologuard test detected 69% of high-grade dysplasia vs 46% with FIT.2
The Cologuard test is an effective screening option that may help you rule out CRC2
83.9%
of Cologuard patients tested negative
In clinical practice, these patients would not need to undergo a colonoscopy2
99.9%
negative predictive value (NPV) for CRC
With a negative result, there was 99.9% certainty that a patient would not have CRC2**
94.8%
NPV for CRC and precancer
With a negative result, there was 94.8% certainty that a patient would not have CRC or an advanced precancerous lesion2**
Patients who receive a negative Cologuard test result do not need a colonoscopy.
Offer the Cologuard test to average-risk patients as defined by the USPSTF and prioritize colonoscopy for those who need it most.2,5
The Cologuard Clinician Brochure details the clinical data and complete prescribing information for the Cologuard test.
All eligible patients whose insurance covers the Cologuard Plus test will receive it. When you place an order, Exact Sciences will determine which test is covered by a patient’s insurance. If it’s the Cologuard Plus test, that is the test they will receive. If not, they will receive the Cologuard test.
No, the Cologuard test and the Cologuard Plus test are not the same test. They utilize different molecular panels to analyze stool samples for CRC. The Cologuard Plus test utilizes 5 biomarkers including DNA methylation markers and hemoglobin, whereas the Cologuard test utilizes 11 biomarkers including altered DNA and hemoglobin. This new molecular panel was designed to increase specificity without decreasing sensitivity.1,2
However, both the Cologuard and Cologuard Plus tests are ordered the same way, follow the same collection process, and come with the same unparalleled patient support.
- 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.
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
There is no head-to-head study that compares these 2 tests, so no conclusions can be drawn about which is more effective. In their respective clinical trials, both tests were shown to effectively detect CRC in comparison to FIT.1,2
- 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.
- 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.
View adherence outcomes with Cologuard-first screening
Find out how the Cologuard test impacts adherence to CRC screening.
The Cologuard test vs FIT
Learn how the Cologuard test compares with another noninvasive CRC screening option in performance and the detection of biomarkers
- Screening colonoscopy was the reference method.1,2
- Cologuard Plus specificity: 91% overall specificity, including all participants who did not have advanced neoplasia. Specificity for no colorectal neoplasia was age-weighted to the US population and defined as a negative colonoscopy, no adenocarcinoma of the colorectum, no adenomas, and no sessile serrated polyps/sessile serrated adenomas.1
- A positive Cologuard result should always be followed up with a colonoscopy.1
- Based on the simulated CRC-SPIN model that compared screening with colonoscopy at a 10-year interval and stool DNA testing at a 3-year interval and assumed perfect adherence in patients aged 45-85 years.13
- OC-Auto® Micro 80, Polymedco, Inc.
- The Cologuard Plus test detected 43% of advanced precancerous lesions vs 23.3% with FIT (P<0.0001).1
- The Cologuard Plus test detected 49% of sessile serrated lesions with dysplasia, traditional serrated adenomas, conventional adenomas with serrated architecture, and sessile serrated lesions ≥10 mm vs 5% with FIT.1
- 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.2
- 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).16,17
- 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.2
- 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.18
- OC FIT-CHEK, Polymedco, Inc.
- The Cologuard test detected 42% of advanced adenomas compared to 24% with FIT (P<0.001).16
- The Cologuard test detected 43% of sessile serrated lesions ≥10 mm vs 5% with FIT (P<0.001).16
APL=advanced precancerous lesion; CRC-SPIN=Colorectal Cancer Simulated Population model for Incidence and Natural history; FIT=fecal immunochemical test; USPSTF=United States Preventive Services Task Force.