Circulating tumor DNA (ctDNA) analysis and advanced tumor profiling in GI cancers highlight opportunities for recurrence monitoring and targeted therapy selection

Modeling analyses and real-world evidence further demonstrate the impact of Cologuard® screening through precancer detection and high-test completion rates

Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, will present 11 abstracts at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) meeting January 23-25, 2025, in San Francisco.

“The data we are presenting at ASCO GI underscore Exact Sciences’ leadership in advancing scientific innovation to drive meaningful progress in cancer detection and patient care,” said Jorge Garces, PhD, chief science officer at Exact Sciences. “These findings exemplify our steadfast commitment to rigorous research and collaboration as catalysts for improving patient outcomes.”

Among the depth and breadth of data to be presented, Exact Sciences will showcase clinical validation results for its molecular residual disease (MRD) test, Oncodetect™, including findings from the Alpha-CORRECT study in Stage III colon cancer patients. This study, which features one of the longest MRD surveillance monitoring periods to date, will be highlighted in a poster at ASCO GI this week and published in a peer-reviewed journal on January 25, 2025. The results demonstrate the test's performance, with 78% sensitivity at the post-surgical timepoint and 91% sensitivity during the surveillance monitoring period, along with specificities of 80% and 94%, respectively¹.

Four of the abstracts presented at ASCO GI confirm that the Cologuard® test and its patient navigation program are associated with strong test completion—also called adherence. The data show high adherence to the triennial test among average risk African Americans (62%), U.S. Hispanic population (63%), U.S. Asian population (69%), and average Risk 45–49-year-olds (65%). These results confirm real-world acceptance and use of Cologuard among these racial subgroups and the 45-49 age group. Although these studies do not measure Cologuard test adherence head-to-head with other tests, the Cologuard adherence reported in these studies is much higher than generally accepted FIT adherence of 42% for that annual test².

In addition, new modeling data from the validated CRC-AIM model shows that screening with triennial Cologuard (mt-sDNA) at published adherence rates results in fewer CRC cases, lower treatment costs, and higher life years gained than screening with blood-based tests at perfect adherence. This abstract (#88) also reinforces the importance of pre-cancer detection in CRC screening.

Abstracts Presented by Exact Sciences:

• Abstract #83, Board C20: Annual Incidence of Colorectal Cancer Among Average Risk Patients in the United States Between 2017 And 2023
• Abstract #88, Board C25: Multi-target stool-DNA test for colorectal cancer screening and effects on health and economic outcomes compared to blood-based tests: Influence of adherence
• Abstract #89, Board C26: Comparison of screening outcomes associated with advanced precancerous lesion versus colorectal cancer sensitivity for a blood-based test: a simulation study
• Abstract #98, Board D10: Trends in Utilization of Colorectal Cancer Screening Modalities Among Average Risk Patients in the United States From 2017 To 2023
• Abstract #99, Board D11: Multi-target Stool DNA Adherence in Average Risk African Americans from 2017-2024
• Abstract #100, Board D12: Adherence with The Multi-target Stool DNA Test in the US Hispanic Population From 2016-2024
• Abstract #101, Board D13: Adherence to Multi-target Stool DNA Test in The US Asian Population From 2017-2024
• Abstract #102, Board D14: Multi-target Stool DNA Test Adherence Among Average Risk 45-49 Year Olds from 2017-2023
• Abstract #268, Board L2: Landscape of Novel Gene Fusions in Gastrointestinal Tumors
• Abstract #302, Poster Board M10: Circulating tumor DNA as a marker of recurrence risk in stage III colorectal cancer: The Alpha-CORRECT study
• Abstract #781, Board K17: Comparison of mutational landscape in primary and metastatic pancreatic tumors

About the Cologuard® and Cologuard Plus™ tests

Developed in collaboration with Mayo Clinic, the Cologuard® and Cologuard Plus™ tests are first-line, non-invasive 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 test at home without special preparation or time off. 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 CRC 18 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. The Cologuard Plus test is expected to reduce false positives by more than 30%, helping minimize unnecessary follow-up colonoscopies. Both tests demonstrate Exact Sciences’ commitment to improving CRC screening access and outcomes. The Cologuard Plus test is expected to launch with Medicare coverage and guideline inclusion in 2025.

About the Oncodetect™ test

Molecular residual disease (MRD) refers to the presence of tumor-specific DNA in the body. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the bloodstream by tumors, and their presence may indicate that cancer is present. Exact Sciences’ MRD offering leverages our in-house capabilities in whole exome sequencing to offer a tumor-informed MRD test for a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By identifying somatic genomic alterations in tumor DNA and detecting a subset in ctDNA from blood, the Oncodetect test may enable the detection of ctDNA before, during, and after treatment. This critical information can guide therapy decisions and monitor for cancer recurrence.

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 of Exact Sciences Corporation. Oncodetect and Oncotype are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Cologuard is only available in the United States.

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. Examples of forward-looking statements include, among others, statements regarding the development and commercialization of our tests and the performance of our tests 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.

References:

1. Schoen RE, Diergaarde B, Young G, et al. Circulating tumor DNA as a marker of recurrence risk in stage III colorectal cancer: The α-CORRECT study. Presented at ASCO GI on January 21, 2025.
2. Piscitello A, et al. (2020) Estimating the impact of differential adherence on the comparative effectiveness of stool-based colorectal cancer screening using the CRC-AIM microsimulation model. PLOS ONE 15(12): e0244431. https://doi.org/10.1371/journal.pone.0244431

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