The American College of Gastroenterology (ACG) Grants Delay Status to the BLUE-C Study at its 2023 Annual Meeting with Presentation of Only Head-to-Face Study Results Compared to FIT at the ‘ACG
The high specificity of the next generation Cologuard test is expected to minimize unnecessary follow-up colonoscopies, promoting positive patient experiences1
MADISON, Wis., October 22, 2023 /PRNewswire/ — Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced late-breaking data from the pivotal BLUE-C trial showing the next generation Cologuard® The test met all study endpoints, demonstrating 94% sensitivity for colorectal cancer (CRC) with 91% specificity, at the 2023 American College of Gastroenterology (ACG) Annual Meeting ).(1) Additionally, results show that the next-generation Cologuard test was significantly more likely to detect cancer or precancer than the fecal immunochemical test (FIT)* (94% vs. 67% and 43% vs. 23%, respectively).(1) Finally, the new generation Cologuard test demonstrated higher sensitivity for the most clinically significant form of advanced precancerous lesions (75% high-grade dysplasia) than FIT (47%).(1)
BLUE-C is one of the largest and most robust CRC screening trials ever conducted. It included more than 20,000 evaluable subjects within a population that aligns with the racial and ethnic diversity of United States.(1,2) Of these participants, the BLUE-C trial identified a total of 98 participants with colorectal cancer. Among them, 82 (83.7%) suffered from stage I to III cancer.(1)
“The BLUE-C results demonstrate a new standard in non-invasive detection of colorectal cancer and precancer, building on the strengths of the current Cologuard,” said Paul Limbourg, MD, MPH, AGAF, chief physician, Screening, Exact Sciences. “The high sensitivity and specificity reported in BLUE-C will help improve the patient experience and contribute to our quest to improve outcomes for this deadly cancer through accurate early detection.”
|
The most advanced |
Next generation |
ADJUST |
|
Sensitivity (%) |
Sensitivity (%) |
|
|
CRC, any |
94 |
67 |
|
Stage I-III |
93 |
65 |
|
Pre-advanced |
43 |
23 |
|
Ranking officer |
75 |
47 |
Note: FIT positivity threshold: hemoglobin > 100 ng/mL. Colorectal cancer stages were defined by the American Joint Committee on Cancer Staging System, 8th ed.
BLUE-C reports high specificity
In addition to its superiority over FIT in terms of sensitivity for colorectal cancer and advanced precancerous lesions, the new generation Cologuard test demonstrated a specificity of 91%.1 The specificity of the FIT was 95%.(1)
“Improving the specificity of non-invasive stool-based screening tests while maintaining high sensitivity is a critical step to advancing colorectal cancer detection and prevention and minimizing the risk of unnecessary follow-up colonoscopies,” said Thomas F. ImperialMD, professor of medicine at Indiana University School of Medicineresearch scientist at the Regenstrief Institute and principal investigator of BLUE-C.
The 91% specificity reported in the BLUE-C trial for patients without advanced neoplasia is higher than the 87% specificity reported in Deep-C, Cologuard’s FDA registration trial.(1.3) For patients with negative or non-neoplastic colonoscopy findings, the specificity of the next generation Cologuard test reached 93%. In this category, the specificity of the FIT was 96%.(1)
Additional analysis presented at ACG further supports performance of next-generation Cologuard
In addition to the crucial BLUE-C data shared at ACG, Exact Sciences presented a analysis that describes an evaluation and validation of performance of the next-generation Cologuard algorithm using a set of known test samples from the original Cologuard Pivotal Study (DeeP-C). In this additional analysis, all performance estimates for the Next Generation Cologuard Assay were equivalent to or better than those for the First Generation Cologuard Assay, confirming reproducibility and supporting the clinically relevant performance of the Next Generation Cologuard Assay.(4)
“Promising data from the 20,000-patient BLUE-C trial presented at the American College of Gastroenterology,” said Seth A. Gross, MD, professor of medicine, NYU Grossman School of Medicine. “The results indicate that the next generation mtDNA test demonstrates even higher sensitivity for screening for colorectal cancer (94%) and high-grade dysplasia (75%), compared to the current Cologuard test. These results suggest that, if approved by the FDA, the mt-sDNA test will be a valuable option for non-invasive colorectal cancer screening.
About the BLUE-C study
BLUE-C was a prospective, multicenter study (NCT04144738) involving more than 20,000 adults ages 40 and older.(1) The trial was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mtDNA). Using colonoscopy as the gold standard method, the robust study design compared next-generation Cologuard and a fecal immunochemical test (FIT*). Blood samples were also collected for further evaluation of a blood screening test developed by Exact Sciences. BLUE-C is one of the largest colorectal cancer screening trials ever conducted, and the study population reflects the racial and ethnic composition of United States according to the 2020 census.(1,2)
About Next Generation Cologuard
Developed in partnership with Mayo Clinic, the next-generation Cologuard test features new biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to give patients more time to return their sample to the Exact Sciences laboratory and increase the rate of valid results.
In the coming months, Exact Sciences plans to release additional analyzes of the BLUE-C data and finalize its application to the FDA for approval of next-generation Cologuard.
About Cologuard
Cologuard has revolutionized colorectal cancer screening by providing a convenient and accurate testing option for people at average risk. Nearly a decade later, Cologuard has been used more than 12 million times to screen for colorectal cancer.
Results from Exact Sciences’ 90-site, single-point-in-time, 10,000-patient prospective pivotal DeeP-C trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s colorectal cancer screening guidelines (2018) and recommendations from the US Preventive Services Task Force (2021) and the National Comprehensive Cancer Network (2023). The Cologuard test is indicated to screen adults 45 years and older at average risk for colorectal cancer by detecting certain DNA markers and blood in stool. Do not use the Cologuard test if you have had precancer, inflammatory bowel disease, and certain hereditary syndromes, or if you have a personal or family history of colorectal cancer. The Cologuard test does not replace colonoscopy in high-risk patients. The performance of the Cologuard test in adults aged 45 to 49 years is estimated based on a large clinical study of patients aged 50 and older. The performance of the Cologuard test in repeated testing has not been evaluated.
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for a colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they should be retested. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuard.com. Rx only.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences provides patients and healthcare professionals with the clarity needed to take life-changing actions sooner. Building on the success of Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during and after a cancer diagnosis. For more information, visit ExactSciences.comfollow Exact Sciences on X (formerly Twitter) @ExactSciencesor search for Exact Sciences on LinkedIn And Facebook.
NOTE: Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. Oncotype is a registered trademark of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.
Forward-looking statements
This press release contains forward-looking statements regarding our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions made by us 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 next generation Cologuard test; performance characteristics of next generation Cologuard in a commercial environment; and the timing and expected results of additional analysis of BLUE-C data and submission to the FDA. 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, as well as in our other reports filed with securities and foreign exchange commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
*The commercially available Polymedco OC-Auto® Micro 80iFOB test
The references
- Imperiale T, et al. Oral presentation 54, ACG 2023.
- United States Census Bureau. Annual estimates of the resident population by year of age and sex for United States: April 1, 2020 has July 1, 2022 (NC-EST2022-AGESEX-RES). Accessed October 16, 2023. https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html
- Imperiale TF, et al. N Engl J Med. 2014;370(14):1287-1297.
- Imperiale T, et al. P0358, ACG 2023.
EXACT SOURCE SCIENCES CORP.
