Exact Sciences to Present Late-Breaking Data from Pivotal BLUE-C Study on Next-Generation Cologuard at ACG 2023

MADISON, Wis., Oct. 9, 2023 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the company will present late-breaking data on next-generation Cologuard^® from the BLUE-C pivotal trial during the American College of Gastroenterology (ACG) Annual Meeting, taking place October 20-25, 2023, in Vancouver, Canada. Further evidence supporting both the cost-effectiveness of Cologuard and performance of next-generation Cologuard will also be presented at the annual meeting. ACG has made abstracts available on their website.  

"The Exact Sciences team works relentlessly to improve upon the strengths of Cologuard, and we are excited to present results from the pivotal BLUE-C study at the upcoming ACG meeting," said Paul Limburg, MD, MPH, AGAF, chief medical officer, Screening, Exact Sciences. "The evidence we'll be sharing speaks to our commitment to patients and high-quality research. Continued innovation is critical when there are 60 million Americans who are not up to date with colorectal cancer screening."

Three abstracts from Exact Sciences will be presented at the annual meeting:

LATE BREAKER – Oral Presentation 54: Next-Generation Cologuard
Presenter:  Thomas F. Imperiale, MD, Indiana University School of Medicine, Regenstrief Institute, BLUE-C Principal Investigator
Session: Tuesday, October 24, 2023; 3:35 p.m. – 3:45 p.m. PT
Location: Ballroom B

Poster Presentation P0358: Next-Generation Cologuard (ACG Award Winner)
Presenter:  Thomas F. Imperiale, MD, Indiana University School of Medicine, Regenstrief Institute, BLUE-C Principal Investigator
Session: Sunday, October 22, 2023; 5:15 p.m. – 6:30 p.m. PT
Location: Exhibit Hall

Poster Presentation P3194: Cologuard (ACG Award Winner)
Presenter:  Derek W. Ebner, MD, Mayo Clinic
Session: Tuesday, October 24, 2023; 1:00 p.m. – 2:15 p.m. PT
Location: Exhibit Hall

Booth Sessions with Q&A
Exact Sciences will host four information sessions at the company's booth (#1101), These sessions will be led by chief medical officer for Screening, Paul Limburg, MD, MPH, AGAF, who has more than two decades of experience as a practicing gastroenterologist and played a key role in the development of next-generation Cologuard. The sessions will focus on the evidence presented at the Annual Meeting. The booth sessions will take place Monday, October 23, and Tuesday, October 24, at 10:30 a.m. PT and 3:35 p.m. PT.

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. The trial was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA). Using colonoscopy as a reference method, the robust study design compared next-generation Cologuard and a fecal immunochemical test (FIT). Blood samples were also collected for later evaluation of a blood-based screening test being 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 makeup of the United States according to the 2020 census.

About Next-Generation Cologuard
Developed in partnership with Mayo Clinic, next-generation Cologuard features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences' lab and increase the valid result rate.

Cologuard revolutionized colorectal cancer screening by providing a convenient and accurate testing option for those at average risk. Nearly a decade later, Cologuard has been used to screen for colorectal cancer more than 12 million times.

In the coming months, Exact Sciences plans to release additional analyses of the BLUE-C data and complete its application to the FDA for approval of next-generation Cologuard.

About Cologuard
Results from Exact Sciences' prospective, 90-site, point-in-time, 10,000-patient pivotal trial, DeeP-C, were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2023). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat 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 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 need to be tested again. 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 gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the 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.com, follow Exact Sciences on Twitter @ExactSciences, or find 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 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 next-generation Cologuard test; the performance characteristics of next-generation Cologuard in a commercial setting; and the timing and anticipated results of additional analysis of the BLUE-C data and 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 Securities and 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.

SOURCE Exact Sciences Corp.