FDA Approves Exact Sciences’ Cologuard Plus Test, Setting a New Benchmark in Non-Invasive Colorectal Cancer Screening
Cologuard Plus™ test raises the performance bar with sensitivities of 95% for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity
Cologuard Plus test will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test
Company expects to launch Cologuard Plus test with Medicare coverage and guideline inclusion in 2025
FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.1*Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test (FIT**) for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.2
“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable – and find advanced precancers, which can prevent cases of this cancer,” said
“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” said
CRC is often considered the most preventable, yet least prevented form of cancer.3 It remains the second deadliest cancer in
*The Cologuard Plus test demonstrates 91% specificity including non-advanced findings, 93% specificity including no findings, and 94% specificity when age-weighted to the
**Refers to the commercially available Polymedco OC-Auto® Micro 80iFOB Test
About the BLUE-C Study
BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of the Cologuard Plus test (multi-target stool DNA or mt-sDNA) and Exact Sciences’ blood-based colorectal cancer screening test. Using colonoscopy as a reference method, the robust study design directly compared the Cologuard Plus test and an independent fecal immunochemical test (FIT*). The BLUE-C study cohort is diverse and reflective of the
About the Cologuard Plus test
Developed in collaboration with
About the Cologuard test
The Cologuard test is a first-line colorectal cancer screening test for use in adults age 45 or older who are at average risk for the disease. It is included in national colorectal cancer screening guidelines by the
The Cologuard test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. The test looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown to effectively detect colorectal cancer and precancer in the pivotal DeeP-C study.The Cologuard test is easy to use, can be completed at home, and does not require any time off or special preparation.
About
A leading provider of cancer screening and diagnostic tests,
NOTE:
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 regarding our expectations for the commercialization of Cologuard Plus, the performance of Cologuard Plus in a commercial setting, and Cologuard Plus’ receipt of Medicare coverage and inclusion in guidelines. 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
References
-
Cologuard Plus Instructions for Use.
Exact Sciences Corporation .Madison, WI. - Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. New Engl J Med. 2024;390(11):984-993.
- Itzkowitz SH. Incremental advances in excremental cancer detection tests. JNCI. 2009;101(18)1225-1227.
-
ACS. Cancer facts & figures 2024.
Atlanta :American Cancer Society ; 2024. -
National Institutes of Health . The Cancer Trends Progress Report.https://progressreport.cancer.gov/detection/colorectal_cancer. AccessedJuly 29, 2024 . -
Ebner DW, Finney Rutten LJ, Miller-
Wilson LA , et al. Trends in Colorectal Cancer Screening from theNational Health Interview Survey : Analysis of the Impact of Different Modalities on Overall Screening Rates. CancerPrev Res (Phila). 2024;17(6):275-280.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241004761985/en/
Media (
Lindsey Dickinson
+1 608-690-0383
lidickinson@exactsciences.com
Investor:
+1 608-800-6605
investorrelations@exactsciences.com
Source: