Oncodetect Test Aims to Detect Recurrence Risk Across Solid Tumors

Oncodetect test uses circulating tumor DNA to assess recurrence risk across solid tumors and guide treatment decisions.

A new test designed to detect molecular residual disease (MRD) across multiple solid tumors, Oncodetect, was announced by Exact Sciences Corp., to provide patients with cancer and their healthcare providers with the insights needed to make more informed decisions throughout the treatment process, according to a news release from the company.

Using whole exome sequencing, the test analyzes circulating tumor DNA shed into the bloodstream, offering insight into changes in DNA levels over time. This quantitative measurement, reported in MTM/mL (mean tumor molecules per milliliter of plasma), helps healthcare providers assess a patient’s disease status.

"Exact Sciences is transforming cancer care by delivering tests that provide the clarity patients and physicians need to make confident decisions," Brian Baranick, executive vice president and general manager of Precision Oncology at Exact Sciences, said in the news release. "After surgery and definitive therapy, such as chemotherapy or radiation, the risk for cancer recurrence remains a major concern. Advanced detection tools like the Oncodetect test help bridge that gap by providing clinical insights at critical periods, leading to more informed treatment decisions and personalized care.”

The Oncodetect test provides a clear “Detected” or “Not Detected” result along with quantitative data to help guide adjuvant therapy, assess treatment response and monitor cancer recurrence. Patients who test positive for circulating tumor DNA with the test during surveillance are 50 times more likely to experience a recurrence than those with negative results. The highly sensitive and personalized test tracks up to 200 tumor-specific variants and can detect a single ctDNA molecule among 20,000 cell-free DNA molecules, allowing earlier detection of colorectal cancer recurrence than imaging alone.

Backed by nearly five years of data from the Alpha-CORRECT study, one of the longest-followed MRD cohorts for colorectal cancer recurrence, the Oncodetect test helps inform recurrence risk and guide personalized treatment decisions. Exact Sciences is working with Medicare to secure reimbursement and expand access, while also advancing validation studies across multiple solid tumors through strategic partnerships.

“Exact Sciences is a longtime trusted partner in addressing the critical unmet needs in colorectal cancer care, ensuring patients have the insights they need to navigate treatment with confidence,” Vanessa Ghigliotty, Certified Patient Navigator and Chair, Patient Advisory Board, GI Cancers Alliance, said in the news release. “For those facing the uncertainty of recurrence, tumor-informed MRD tests like the Oncodetect test can provide clear, timely answers — empowering patients to take an active role in their care and receive the right treatment at the right time for better outcomes.”

The Oncodetect test builds on 20 years of genomic testing established by the Oncotype DX Breast Recurrence Score and is integrated into a digital platform supported by ExactNexus. It can be ordered with other Exact Sciences tests, including OncoExTra for genomic profiling and Riskguard for hereditary cancer testing. With more than three million Americans eligible for MRD testing, Exact Sciences aims to help advance personalized care, as per the release.

The ALPHA-CORRECT Study and Beta-CORRECT Study

At the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers (GI) Symposium, results from the Alpha-CORRECT study showed the Oncodetect test reached 78% sensitivity after surgery and 91% during surveillance, with specificities of 80% and 94%, respectively.

Furthermore, Oncodetect met its primary endpoint in the Beta-CORRECT study, confirming a strong link between MRD positivity and recurrence in patients with stage 3 colon cancer. In addition to data shared at ASCO GI, the findings support Oncodetect’s prognostic value in patients with stage 2 and 4 colon cancer and rectal cancer.

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