Exact Sciences Presents New Findings at ACG 2025 Demonstrating How the Cologuard Test Helps Improve Adherence and Close Screening Gaps

Studies show higher completion rates for mt-sDNA testing and the positive impact of patient navigation in expanding access to underserved and older populations

MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced new data being presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 24–29, 2025, at the Phoenix Convention Center in Phoenix, Arizona. The company’s research showcases leadership in advancing colorectal cancer (CRC) screening through high-quality science, real-world evidence, and innovations that improve screening adherence and access across diverse patient populations. ACG abstracts are available on their website.

“Exact Sciences’ research at ACG 2025 underscores our leadership in advancing evidence-based, patient-centered screening solutions that improve adherence and outcomes,” said Paul Limburg, MD, MPH, AGAF, Chief Medical Officer for Screening, Exact Sciences. “The data continue to highlight how our comprehensive support, coupled with robust science, make Cologuard and Cologuard Plus best-in-class tools for early colorectal cancer detection.”

The studies presented at ACG 2025 align with Exact Sciences’ mission to increase screening participation in underserved and vulnerable populations, including those served by Federally Qualified Health Centers, safety-net facilities, Rural Health Clinics, and the Indian Health Service. The findings reinforce the importance of multifaceted programs, outreach and patient support in overcoming persistent barriers to screening and follow-up care.

The abstracts at ACG are as follows:

(RWE.88) Reaching the Unscreened: Adherence Outcomes from an mt-sDNA CRC Screening Care Gap Program

• Summary: Among 2,095 Medicare Advantage enrollees without a point-of-care mt-sDNA test order, 53.4% of prior mt-sDNA users and 38.8% of those with previous use of another stool-based test completed screening through a care gap closure program. Prior mt-sDNA users were 74% more likely to complete screening than those with prior FIT use. Digital communications significantly improved engagement, with participants 129% more likely to complete testing after receiving digital outreach. CRC screening care gap programs demonstrate the potential to improve CRC screening rates by reaching individuals who may otherwise not interact with the health care system.
• Session: Monday, October 27, 2025, 10:30 AM – 4:00 PM

(REC.10.3) FIT-Based Colorectal Cancer Screening Completion Rates (Initial Test and Follow-up Colonoscopy) by Health Facility Type: A Systematic Review and Meta-Analysis

• Summary: Across 47 studies evaluating 405 intervention strategies, overall adherence to FIT screening was 35.7%, increasing modestly to 39.4% among those receiving an intervention, compared with 26.1% without intervention. Adherence to follow-up colonoscopy after a positive FIT was 46.6%, underscoring substantial gaps in completion rates.
• Session: Tuesday, October 28, 2025, 10:30 AM – 4:00 PM

(MS.44) One-Time Colorectal Cancer Screening with Next-Generation mt-sDNA vs FIT: Clinical and Economic Impact Using a Comprehensive Cost-Calculator Economic Model

• Summary: A hypothetical cohort of 1 million average-risk individuals was modeled to simulate the estimated outcomes from one round of next-generation mt-sDNA versus FIT screening. Next-generation mt-sDNA screened more than twice as many patients as FIT (713,000 vs 318,000) and achieved 5.7x more HEDIS® quality targets. It detected 5.5x more advanced precancerous lesions (21,701 vs 3,328), 3.7x more colorectal cancer cases (2,090 vs 440), and prevented 5.5x more cancers (1,736 vs 266). It also cut treatment costs by 3% and total costs by 2% compared to FIT ($1,388M vs $1,423M).
• Session: Monday October 27, 2025, 10:30 AM – 4:00 PM

About the Cologuard^® and Cologuard Plus™ tests

Developed in collaboration with Mayo Clinic, the Cologuard^® and Cologuard Plus^™ tests are first-line, noninvasive colorectal cancer (CRC) screening options for adults aged 45 or older who are at average risk for the disease. The Cologuard test revolutionized CRC screening by detecting specific DNA markers and blood in stool associated with cancer and precancer, allowing patients to complete the collection kit at home without special preparation or time off, and return the kit to the lab for results. It is included in national screening guidelines from the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021). Since its inception in 2014, Cologuard has been used to screen for more CRC 20 million times.

Building on this success, the FDA-approved Cologuard Plus test raises the performance bar even further and features novel biomarkers, improved laboratory processes, and enhanced sample stability. Through high performance, the Cologuard Plus test is designed to reduce the likelihood of false positives, helping to minimize unnecessary follow-up colonoscopies. Both tests demonstrate Exact Sciences’ commitment to improving CRC screening access and outcomes.

About Exact Sciences

A leading provider of cancer screening and diagnostic tests, Exact Sciences (Nasdaq: EXAS) helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company’s growing portfolio includes well-established brands such as Cologuard® and Oncotype DX®, along with innovative solutions like the Cancerguard® test for multi-cancer early detection and the Oncodetect® test for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit ExactSciences.com, follow @ExactSciences on X, or connect on LinkedIn and Facebook.

NOTE: Exact Sciences, Cologuard, Cologuard Plus, and Cancerguard are trademarks of Exact Sciences Corporation. Oncotype DX and Oncodetect are registered trademarks of Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation.

Forward-looking statement

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. 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.