The New England Journal of Medicine Publishes Cologuard Plus™ Test Results from Pivotal BLUE-C Study
Cologuard Plus is only noninvasive test to be evaluated head-to-head against an independent fecal immunochemical test, which it significantly outperformed
20,000-participant BLUE-C study included 98 colorectal cancers and reflects racial and ethnic diversity of
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The 20,000-participant BLUE-C study was designed to determine the performance characteristics of Exact Sciences’ next-generation multitarget stool DNA test, Cologuard Plus, for colorectal cancer (CRC) and to compare that performance to the fecal immunochemical test (FIT), a commonly used noninvasive CRC screening test.
Cologuard Plus met all BLUE-C study endpoints, demonstrating 94% sensitivity for CRC at 91% specificity including non-advanced findings, and 93% specificity including no findings. Specificity was even better in younger age groups, at 96% in 45-54 year olds. Cologuard Plus will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test.
Results from BLUE-C also show Cologuard Plus significantly outperformed an independent FIT* for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.
Cologuard
|
Independent
|
|
Cancer sensitivity |
94 |
67 |
Specificity including non-advanced findings |
91 |
95 |
Specificity including no findings |
93 |
96 |
Stages I-III cancer sensitivity |
93 |
65 |
High-grade dysplasia sensitivity |
75 |
47 |
Advanced precancer sensitivity |
43 |
23 |
Note: specificity including non-advanced findings includes colonoscopy results that were negative for cancer or advanced precancer upon histopathological review; specificity including no findings includes no findings on colonoscopy and no histopathological review; high-grade dysplasia is a subtype of advanced precancer that includes carcinoma in situ or stage 0 cancer |
To potentially expand the eligible screening population beyond average-risk patients, the BLUE-C study enrolled a small subset of participants with a first-degree relative with a history of CRC. Sensitivities for CRC and advanced precancerous lesions were similar among participants with a first-degree relative with a history of CRC and those without such a relative.
Among the subset of nearly 19,000 participants who were average-risk, without a first-degree relative with a history of CRC, Cologuard Plus exhibited 95% sensitivity for CRC and 43% sensitivity for advanced precancerous lesions at a 91% specificity including non-advanced findings, or 94% specificity including no findings.
“Cologuard Plus is highly sensitive for detecting colorectal cancer,” said
The prospective, multi-center BLUE-C study utilized colonoscopy as a reference method, directly comparing Cologuard Plus and an independent FIT. BLUE-C investigators also collected blood samples for evaluation of a blood-based CRC screening test developed by
“BLUE-C’s publication in
The BLUE-C study cohort was diverse and reflective of the
“Many of the 53,000 Americans killed by colorectal cancer each year come from communities of color, a disparity we must work together to eliminate,” said
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About the BLUE-C Study
BLUE-C was a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older.1 The trial was designed to evaluate the performance of Cologuard Plus (next generation multitarget stool DNA or mt-sDNA). Using colonoscopy as a reference method, the robust study design directly compared Cologuard Plus and an independent FIT. Blood samples were also collected for evaluation of a blood-based screening test developed by
About Cologuard Plus
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A leading provider of cancer screening and diagnostic tests,
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Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the development and commercialization of the Cologuard Plus test; the performance characteristics and healthcare benefits of Cologuard Plus in a commercial setting; and the timing and anticipated results of FDA submission. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the
*The commercially-available Polymedco OC-Auto® Micro 80 iFOB Test
References
- Imperiale T, et al. N Engl J Med (2024)
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United States Census Bureau . Annual Estimates of the Resident Population by Single Year of Age and Sex forthe United States :April 1, 2020 toJuly 1, 2022 (NC-EST2022-AGESEX-RES). Accessed16 October 2023 . https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html
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