Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™ Test and Molecular Residual Disease Innovation Roadmap

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced new data to be presented from the Beta-CORRECT clinical validation study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Results from Beta-CORRECT, a subset of the GALAXY cohort, validate the performance of its tumor-informed molecular residual disease (MRD) test, Oncodetect™, in predicting recurrence in stage II–IV colorectal cancer. These data confirm the test’s role in supporting treatment and surveillance decisions.

Building on this momentum and its commitment to innovation, Exact Sciences will introduce a next-generation version of the test leveraging the Broad Institute’s MAESTRO technology. Early data show the test will track up 5,000² patient specific variants and detect ctDNA^* levels below 1 part per million.¹ The test will be available to both new and existing customers in 2026.

“We launched the Oncodetect test to give clinicians and patients a powerful tool for detecting cancer recurrence earlier and with greater precision—progress that’s already being realized,” said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. “We continue to innovate and look forward to introducing the next iteration of the Oncodetect test, which leverages whole-genome sequencing and proprietary technology developed in collaboration with the Broad Institute to enhance sensitivity and expand clinical utility.”

The Beta-CORRECT study demonstrates that the Oncodetect test significantly improves prognosis prediction compared to traditional standard of care methods ^†,3,4,5

Data presented at ASCO from the Beta-CORRECT clinical validation study confirm that the Oncodetect test accurately predicts recurrence in stage III colorectal cancer³—consistent with findings from the Alpha-CORRECT study—and extends this association to stages II and IV.⁴

Exact Sciences’ largest MRD clinical study to date, with more than 400 patients, demonstrates those with ctDNA-positive results after therapy and during surveillance showed a 24- and 37-fold increased risk of recurrence, respectively.⁴ By quantifying ctDNA levels across multiple timepoints, the Oncodetect test enables physicians to more effectively guide treatment decisions and surveillance strategies in clinical practice.^3,4

Advancing the Oncodetect test with next generation innovation

The next-generation MRD test, currently in validation across multiple solid tumor types, will track up to 5,000 patient-specific variants² with a limit of detection below 1 part per million,¹ enabling scalable monitoring and broad clinical utility. Exact Sciences holds exclusive rights to the Broad Institute’s MAESTRO technology, a whole-genome sequencing method able to detect low-frequency ctDNA mutations with high accuracy. This technology advances the ability to look broadly across thousands of mutations while reducing the sequencing depth required to achieve an ultra-low limit of detection at a highly attractive cost point. Through continued innovation in MRD, Exact Sciences is advancing solutions with the potential to change clinical practice.

“The precision and sensitivity seen in the next generation test reflect deep scientific collaboration and a shared commitment to advancing MRD technology,” said Viktor Adalsteinsson, Ph.D., Director, Gerstner Center for Cancer Diagnostics at the Broad Institute. “This approach to innovation will continue to raise the bar for recurrence monitoring, treatment response assessment, and, ultimately, patient outcomes.”

* Circulating tumor DNA

† Standard of care markers include CEA and clinicopathologic factors

References:

1. Edward S. Sim, Justin Rhoades, Kan Xiong, Laurel Walsh, Andjela Crnjac, Timothy Blewett, Yana Al-Inaya, Julia Mendel, Daniel A. Ruiz-Torres, Vasileios Efthymiou, Gjystina Lumaj, William J. Benjamin, G. Mike Makrigiorgos, Shervin Tabrizi, Viktor A. Adalsteinsson, Daniel L. Faden; Early Postoperative Minimal Residual Disease Detection with MAESTRO Is Associated with Recurrence and Worse Survival in Patients with Head and Neck Cancer. Clin Cancer Res 2025; https://doi.org/10.1158/1078-0432.CCR-25-0307
2. Data source on file. Exact Sciences. Madison, WI. May 2025.
3. Diergaarde B, Young G, Hall DW, et al. Circulating tumor DNA as a marker of recurrence risk in stage III colorectal cancer: the α-CORRECT study. J Surg Oncol. Jan 2025.
4. Hashimoto et. al: The Association of ctDNA with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT study. Presented at ASCO 2025.
5. ASCO 2025 Industry Expert Theater Presentation: Molecular Residual Disease Testing with Exact Sciences’ Oncodetect test: Product and Clinical Data Overview.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences helps give patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard^® and Oncotype DX^® 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.

Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences and Cologuard are trademarks of Exact Sciences Corporation. Oncodetect 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 our expectations for the commercialization of the Oncodetect and next-generation MRD tests, the performance characteristics and health care benefits of the Oncodetect and next-generation MRD tests in a commercial setting, and launch date for the next-generation MRD test. 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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