On January 21, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported clinical validation data for its OncodetectTM MRD test at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 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%, respectively (Press release, Exact Sciences, JAN 21, 2025, View Source [SID1234649790]). 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.
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"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 (Free ASCO Whitepaper) 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 ExactNexusTM 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-basedCORRECT-Istudy and the pivotal, US-basedCORRECT-IIstudy 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 waspreviously announced with the West German Study Group.
The company has also partnered withFlatiron Healthon 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.