New Evidence Validates Oncodetect's™ Ability to Detect Molecular Residual Disease and Predict Recurrence in Colorectal Cancer Patients

Results from prospective molecular residual disease (MRD) study show a positive Oncodetect test result is strongly associated with recurrence in stage III colon cancer patients

Oncodetect test achieved the primary endpoint in a second clinical validation study, extending its prognostic value into stages II and IV colon cancer and rectal cancer

Exact Sciences plans to launch the Oncodetect test in Q2 2025 with Medicare coverage

Key collaborations support clinical evidence generation across multiple solid tumor types

Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, shared clinical validation data for its Oncodetect^TM MRD test at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI.) Results from Alpha-CORRECT, a study with one of the longest MRD surveillance monitoring periods to date, showed the Oncodetect test achieved 78% sensitivity at the post-surgical timepoint and 91% sensitivity during the surveillance monitoring period, with specificities of 80% and 94%, respectively¹. The complete findings of the study, which primarily included patients with stage III colon cancer, will be published in a peer-reviewed scientific journal on January 25.

“We’re thrilled to bring our MRD solution to the rapidly growing molecular residual disease market, helping more patients get access to critical, high-quality testing,” said Brian Baranick, general manager of Precision Oncology at Exact Sciences. “These data demonstrate the strong performance of Oncodetect. Building on the foundation of Oncotype DX^® and two decades of trust from physicians and patients, Exact Sciences is well positioned to lead the way with its robust commercial and operational infrastructure, to ensure patients across the U.S. have access to MRD testing.”

In addition to the data shared at ASCO GI, Oncodetect achieved its primary endpoint in the Beta-CORRECT study. Results confirm a significant association between MRD positivity and recurrence in patients with stage III colon cancer. The data extend Oncodetect’s prognostic value to patients with stage II and IV colon cancer and rectal cancer. Findings from the independent Beta-CORRECT clinical validation study, which was a subset analysis from the GALAXY study, also demonstrated promising performance of Oncodetect as an MRD test. Results will be presented at an upcoming scientific conference.

“There is a critical need to better understand and monitor for residual cancer following surgery,” said Takayuki Yoshino, MD, deputy director at the National Cancer Center Hospital East in Japan. “The Oncodetect test represents an exciting development in the field. I am pleased to partner with Exact Sciences, encouraged by the emerging data from the Beta-CORRECT study, and look forward to sharing further insights in the coming months.”

The company plans to provide the Oncodetect test to patients across the United States through its Precision Oncology platform, combining 20 years of deep relationships with healthcare professionals through Oncotype DX, a broad portfolio of oncology solutions, and the advanced ExactNexus^TM technology platform.

Strategic Partnerships Support Multi-Cancer Evidence Generation

Exact Sciences has partnered with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Flatiron Health to generate additional clinical evidence across multiple solid tumor types.

• Exact Sciences is conducting multiple studies to strengthen evidence in colorectal cancer. The international-based CORRECT-I study and the pivotal, US-based CORRECT-II study with the NSABP will assess the association between ctDNA and recurrence at specific post-surgical timepoints in patients with stage II and III colorectal cancer. These studies will further validate ctDNA’s role in colorectal cancer recurrence monitoring.

• An additional study with the NSABP, EXActDNA-003, is one of the largest prospective MRD studies across all subtypes of early-stage breast cancer. Additional research in breast cancer was previously announced with the West German Study Group.

• The company has also partnered with Flatiron Health on a multi-year, prospective real-world study that will be integrated into routine clinical care, with the goal of accelerated enrollment across a broad range of solid tumors.

“The NSABP is committed to advancing colorectal and breast cancer care through innovative clinical studies that redefine diagnostics and treatments,” said Dr. Norman Wolmark, MD, chairman of the NSABP Foundation and contact principal investigator and co-chair at NRG Oncology. “Both the CORRECT-II and EXActDNA-003 studies are designed to utilize ctDNA in addressing critical gaps left by previous MRD trials. Through our collaboration with Exact Sciences, we aim to integrate ctDNA analysis to deliver a more precise and comprehensive approach to recurrence detection.”

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’ Precision Oncology portfolio

Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score^® test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra^® test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. To learn more, visit precisiononcology.exactsciences.com.

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.

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 test and the performance of the Oncodetect 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.

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.

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