Exact Sciences Demonstrates Continued Scientific Advancement in Colorectal Cancer Screening with Multiple Data Presentations at DDW® 2024

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, announced today the company will present six abstracts on strategies and advancements for improving colorectal cancer screening rates and outcomes during Digestive Disease Week^® (DDW) 2024, May 18-21 in Washington, D.C. This includes data on Cologuard^®, the best-in-class non-invasive screening test for colorectal cancer in patients 45 and older at average risk, and the next-generation Cologuard test in development, Cologuard Plus^™. Further details can be found at ddw.org.

“At Exact Sciences, we know colorectal cancer screening must be able to find and also help prevent the disease to positively impact patient outcomes, which is how the Cologuard test was designed,” said Paul Limburg, MD, MPH, AGAF, chief medical officer for screening, Exact Sciences. “In addition to effective detection rates for cancers, pre-cancers and low false positive rates, patients need options that are convenient and easy to use. Up to 40% of the screening-eligible population in the U.S. currently needs to be screened for colorectal cancer and our data at DDW can inform strategies to meaningfully address this critical gap.”¹

The following abstracts from Exact Sciences have been accepted for presentation at the annual meeting:

Session Type: Research Forum

Session Title: Colorectal Cancer Screening and Surveillance: Cohort, Clinical Outcomes & Comparative Effectiveness Studies including Trials

Session Date & Time: Saturday, May 18, from 12:30 p.m. to 1:30 p.m. EDT

Presentation Title: Comparison Of Efficient Frontier Strategies For Guideline-endorsed Vs Non-endorsed Colorectal Cancer Screening Tests

Session Type: Research Forum

Session Title: Colorectal Cancer Screening and Surveillance: Cohort, Clinical Outcomes & Comparative Effectiveness Studies including Trials

Session Date & Time: Saturday, May 18, from 12:30 p.m. to 1:30 p.m. EDT

Presentation Title: Comparison Of Efficient Frontier Strategies For Stool-based Colorectal Cancer Screening Tests

Session Type: Research Forum

Session Title: Colorectal Cancer Screening and Surveillance: Cohort, Clinical Outcomes & Comparative Effectiveness Studies including Trials

Session Date & Time: Saturday, May 18, from 12:30 p.m. to 1:30 p.m. EDT

Presentation Title: Estimated Average-risk Colorectal Cancer Screening-eligible Population In The U.S.

Session Type: Research Forum

Session Title: Colorectal Cancer Screening and Surveillance: Cohort, Clinical Outcomes & Comparative Effectiveness Studies including Trials

Session Date & Time: Saturday, May 18, from 12:30 p.m. to 1:30 p.m. EDT

Presentation Title: Eliminating The Colonoscopy Backlog With Stool-based Colorectal Cancer Screening Options

Session Type: Research Forum

Session Title: Cancer, Early Detection, Biomarkers for Diagnosis, Treatment and Prognosis of GI Cancers

Session Date & Time: Sunday, May 19, from 12:30 p.m. to 1:30 p.m. EDT

Presentation Title: Fecal Immunochemical Test (Fit) Performance Characteristics In Males And Females: Should The Threshold Vary?

Session Type: Research Forum

Session Title: Health Disparities in Patients with GI Disease

Session Date & Time: Tuesday, May 21, from 12:30 p.m. to 1:30 p.m. EDT

Presentation Title: Impact Of Racial Disparities In The Quality Of Colonoscopy Screening On Colorectal Cancer Incidence And Mortality: A Simulation Modeling Analysis

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 X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

NOTE: Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.

About Digestive Disease Week

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

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.

References

1. Siegel RL, et al. 2023. CA Cancer J Clin. 2023;73(3):233-254.

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