Modeling data show Cologuard Plus^TM test delivers highest life-years gained with fewest number of colonoscopies among noninvasive colorectal cancer (CRC) screening strategies

Additional abstracts support real-world expertise and experience in increasing patient adherence, especially in underserved populations

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the company will present modeling data evaluating the simulated benefit and burden of established CRC screening strategies, including the Cologuard Plus™ test during the American College of Gastroenterology (ACG) Annual Meeting. ACG takes place October 25-30, 2024, in Philadelphia, Pennsylvania. Exact Sciences will also present new data on improving adherence to help close the gap in CRC screening. ACG abstracts are available on the meeting website.

“Exact Sciences is pleased to share new modeling data which demonstrates the Cologuard Plus test as an efficient CRC screening strategy across modeled age ranges and screening intervals, given its high sensitivity and specificity for both cancer and precancer,” said Paul Limburg, MD, MPH, AGAF, chief medical officer for Screening, Exact Sciences. “The data demonstrate our commitment to continuous improvement and innovation to deliver best in class, patient-centric cancer screening and diagnostic solutions.”

Researchers used a validated simulation model to assess the benefit to burden ratio of the Cologuard Plus test and other established and emerging CRC screening options. Benefit was defined as life-years gained and burden as the lifetime number of colonoscopies.

The efficient frontier abstract summary and presentation details are as follows:

• Next Generation mt-sDNA Has the Best Balance Between Benefit and Burden of Age- and Interval-Recommended CRC Screening Among Stool- and Blood-Based Tests (P2119)
  • Summary: The next-generation mt-sDNA (ng-mt-sDNA) test was the only efficient non-invasive modality for screening over the guideline-recommended age interval of 45-75 years; Blood-based screening strategies were not efficient or near-efficient at any screening interval or age-range.
  • Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT

Increasing real-world adherence

The seven remaining abstracts share patient-centric research on improving CRC screening adherence rates, particularly in underserved populations. With industry-leading patient navigation and personalized outreach, these strategies directly impact millions of lives. When modeled against the U.S. general screening population, widespread implementation of the reported strategies could drive as much as a 10% reduction in the CRC screening gap.*

The abstracts at ACG are as follows:

• Cross Sectional Adherence with the Multi Target Stool DNA Test for Colorectal Cancer Screening Among Four Largest Payors in the Country (P0437)
  • Summary: This study demonstrates high adherence rates to mt-sDNA testing across a large, national sample of insured individuals between ages 45-85 years, with an overall cross-sectional adherence of 71.2% and an average return time of 27.3 days.
  • Session: Sunday, October 27, 2024, 3:30 PM – 7:00 PM EDT

• Real-World Multi-Target Stool DNA Longitudinal Adherence for Colorectal Cancer Re-screening in a Large, National Spanish-Speaking Population (P3827)
  • Summary: The overall adherence rate in this population was 76.7%, with a mean time to test return of 20.2 days; Personalized patient navigation outreach with Spanish language support resulted in adherence rates exceeding 70% for CRC re-screening, across all analyzed age subgroups.
  • Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT

• Gap Closure Adherence to Multi-Targeted Stool DNA Test for Colorectal Cancer Screening in an Insured Cohort (P0436)
  • Summary: The gap closure program achieved nearly 50% adherence, with an average of 25.5 days to return the kit; This supports mt-sDNA as an effective modality to enhance CRC screening participation.
  • Session: Sunday October 27, 2024, 3:30 PM – 7:00 PM EDT

• Impact of Personalized Patient Outreach on Multi-Target Stool DNA Test Adherence in a Large Colorectal Cancer Screening Population (P2120)
  • Summary: Personalized patient outreach significantly improved mt-sDNA adherence for CRC screening compared to standard outreach, 63% vs 61.1% respectively.
  • Session: Tuesday, October 29, 2024, 10:30 AM – 4:00 PM EDT

• Impact of Spanish Language Outreach on Multi-Target Stool DNA Test Adherence in a Spanish-Speaking Population in a Federally Qualified Health Center (P3825)
  • Summary: Preference-based multichannel navigation with Spanish language outreach significantly improved patient adherence to CRC screening in the FQHC Spanish-speaking population, increasing adherence from 45.10% to 51.60%.
  • Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT

• Impact of Preference-Based Digital Navigation on Multi-Target Stool DNA Test Adherence in a Large Colorectal Cancer Screening Population (P2118)
  • Summary: Overall mt-sDNA adherence was 63.7% and analysis by communication type revealed that mt-sDNA significantly improved adherence: SMS + email (66.5%), SMS (62.9%), email (64.2%), no digital (57.4%). Additionally, SMS + email demonstrated the shortest average return time (20.1 days).
  • Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT

• Impact of Spanish Language Patient Navigation on Multi-Target Stool DNA Test Adherence Among Spanish-Speaking Patient Population (P3826)
  • Summary: Personalized Spanish-language outreach in a predominantly Spanish-speaking Hispanic patient population significantly improved mt-sDNA adherence rates; The Spanish language outreach group exhibited higher mt-sDNA adherence than English language outreach group (62.0% vs. 57.3%), while also exhibiting increased odds of mt-sDNA adherence.
  • Session: Tuesday, October 29, 2024, 10:30 AM – 4:00 PM EDT

Meet Exact Sciences Booth Event

Exact Sciences will host two information sessions at the company’s booth (#839), These sessions will be led by Burak Ozbay, PhD, MBA, BPharm, Vice President of Health Economics and Outcomes Research. The sessions will focus on precancer detection and what modeling can inform about CRC screening tests. The booth sessions will take place Sunday, October 27 and Monday, October 28 at 5:30 pm and 10:45 am EDT.

*Estimates based on modeling abstract performance against U.S. based population cohorts of: # of Medicare Advantage members, U.S. Hispanics and unscreened U.S. citizens.

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 the Cologuard Plus™ test

Developed in collaboration with Mayo Clinic, the Cologuard Plus test 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. Exact Sciences expects to launch the test with Medicare coverage and guideline inclusion in 2025.

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 American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021).

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 phase 3 DeeP-C study. The Cologuard test is easy to use. It can be completed at home and does not require any time off or special preparation. In the initial 10 years since launch, the Cologuard test was used more than 16 million times.

Important Information About the Cologuard Test

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, Cologuard and Cologuard Plus are trademarks or registered trademarks of Exact Sciences Corporation. Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, RSClin, and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners. Cologuard is not available outside of the U.S.

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 the Cologuard Plus test and the performance of the Cologuard Plus test in a commercial setting. 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.

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