Oncodetect Test Is Now Available for MRD Detection in Solid Tumors

MRD in Solid Tumors |
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The Oncodetect test is now available for use in molecular residual disease (MRD) detection in patients with solid tumors.1

Oncodetect is a highly sensitive, tumor-informed test designed to detect up to 200 circulating tumor DNA (ctDNA) variants. The test delivers a clear "detected" or "not detected" readout, and it also provides quantitative data intended to drive adjuvant therapy decision-making, determine treatment response, and monitor for disease recurrence. The test can also detect ctDNA down to 1 molecule in every 20,000 circulating free DNA molecules.

"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, Precision Oncology at Exact Sciences, stated in a press 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.”

Findings from the Alpha-CORRECT trial presented at the 2025 Gastrointestinal Cancers Symposium demonstrated that Oncodetect produced a sensitivity rate of 77.8% following surgery and 90.9% during monitoring in patients with stage 3 colon cancer.2,3 The specificity rates at these time points were 80.3% and 94.3%, respectively.3

Findings also showed that patients who were ctDNA negative at the post-surgery time point (n = 57) achieved a 3-year relapse-free survival (RFS) rate of 96.1% compared with 54.5% for those who were ctDNA positive (n = 31; HR, 9.6; 95% CI, 3.2-29.5; P < .0001).

When sorting by ctDNA status during the surveillance period, the recurrence rates were 2.3% for patients who were ctDNA negative at all testing points (n = 84) vs 81.5% for those who had at least 1 positive ctDNA test (n = 27).

When sorting by ctDNA status at the post-definitive therapy time point following the completion of adjuvant treatment, the 3-year RFS rates were 90.0% for patients who were ctDNA negative (n = 86) vs 18.2% for those who were ctDNA positive (n = 11; HR, 16.7; 95% CI, 6.9-40.3; P < .0001).

Alpha-CORRECT included patients with stage 3 colorectal cancer (CRC) who were enrolled across 19 sites in western Pennsylvania from 2016 to 2020. The study included 124 patients who underwent at least 1 ctDNA analysis.

The ctDNA analyses were conducted after surgery, after definitive therapy, and then serially during surveillance. In the surveillance window, blood was drawn every 3 months in years 1 to 3 following surgery, then once every 6 months.

The association between RFS and ctDNA status during surveillance served as the trial's primary end point. Second end points included the association between RFS and ctDNA status at other time points; the sensitivity and specificity of Oncodetect at different time points; and the association between ctDNA and other clinicopathologic factors.

In an announcement of the launch of Oncodetect, Exact Sciences said that the company is working with Medicare regarding reimbursement, and the test is being advanced in clinical and analytical validation studies in multiple solid tumors.1

“Exact Sciences is a longtime trusted partner in addressing the critical unmet needs in CRC care, ensuring patients have the insights they need to navigate treatment with confidence,” Vanessa Ghigliotty, certified patient navigator and chair of the Patient Advisory Board at GI Cancers Alliance, added in a 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.”

References

1. Exact Sciences launches the Oncodetect™ molecular residual disease test. News release. Exact Sciences. April 22, 2025. Accessed April 22, 2025. https://www.exactsciences.com/news-events/press-releases/exact-sciences-launches-the-oncodetect-molecular-residual-disease-test
2. New evidence validates Oncodetect’s ability to detect molecular residual disease and predict recurrence in colorectal cancer patients. News release. Exact Sciences. January 21, 2025. Accessed April 22, 2025. https://www.exactsciences.com/news-events/press-releases/new-evidence-validates-oncodetect-s-ability-to-detect-molecular-residual-disease
3. Schoen R, Diergaarde B, Young G, et al. Circulating tumor DNA as a marker of recurrence risk in stage III colorectal cancer: The α-CORRECT study. J Clin Oncol. 2025;43(supp 4):302. doi:10.1200/JCO.2025.43.4_suppl.302