Exact Sciences Corp. (Nasdaq: EXAS) has announced clinical validation data for its Oncodetect™ MRD (molecular residual disease) test, showcasing its ability to detect residual disease and predict recurrence in colorectal cancer patients. The data, shared at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), highlights the potential of Oncodetect to improve post-surgical monitoring and treatment decisions.
Alpha-CORRECT Study Results
The Alpha-CORRECT study, which featured one of the longest MRD surveillance monitoring periods to date, demonstrated that Oncodetect achieved 78% sensitivity at the post-surgical timepoint and 91% sensitivity during the surveillance monitoring period. The specificities were 80% and 94%, respectively. The study primarily included patients with stage III colon cancer, and the complete findings are set to be published in a peer-reviewed scientific journal on January 25.
Beta-CORRECT Study Results
In addition to the Alpha-CORRECT data, the Oncodetect test also achieved its primary endpoint in the Beta-CORRECT study. The results confirmed a significant association between MRD positivity and recurrence in patients with stage III colon cancer. Furthermore, the data extends Oncodetect’s prognostic value to patients with stage II and IV colon cancer, as well as rectal cancer. The Beta-CORRECT study was an independent clinical validation study and a subset analysis from the GALAXY study. These results will be presented at an upcoming scientific conference.
Commercialization and Strategic Partnerships
Exact Sciences plans to launch the Oncodetect test in the second quarter of 2025, with the aim of securing Medicare coverage. The test will be offered through the company's Precision Oncology platform, leveraging its established relationships with healthcare professionals through Oncotype DX and the ExactNexus™ technology platform.
"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."
Exact Sciences is also collaborating with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Flatiron Health to generate additional clinical evidence across multiple solid tumor types. Studies such as CORRECT-I, CORRECT-II, and EXActDNA-003 are designed to assess the association between ctDNA and recurrence at specific post-surgical timepoints in patients with stage II and III colorectal cancer and early-stage breast cancer.
About Oncodetect
Oncodetect is a tumor-informed MRD test that uses whole exome sequencing to detect and monitor residual cancer in patients with solid tumors. By identifying somatic genomic alterations in tumor DNA and detecting a subset in ctDNA from blood, the test aims to detect ctDNA before, during, and after treatment, guiding therapy decisions and monitoring for cancer recurrence.
"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."
