Exact Sciences has announced positive results from its Alpha-CORRECT study evaluating the performance of its Oncodetect test in detecting molecular residual disease (MRD). The study showcased the test's ability to identify remaining cancer cells after initial treatment, with a sensitivity of 78% in post-surgical checks and 91% during surveillance monitoring. Specificity was also high, at 80% and 94% respectively.
Oncodetect's Performance in MRD Detection
Molecular residual disease (MRD) refers to the presence of tumor-specific DNA, also known as circulating tumor DNA (ctDNA), that remains in the body after surgery or chemotherapy. Exact Sciences' Oncodetect utilizes whole exome sequencing to detect this ctDNA, providing a comprehensive assessment of MRD status.
Brian Baranick, general manager of precision oncology at Exact Sciences, stated, "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. This data demonstrates Oncodetect’s strong performance."
Beta-CORRECT Study and Future Trials
The Oncodetect test also achieved its primary endpoint in the Beta-CORRECT study, which examined the association between MRD positivity and recurrence in patients with stage III colon cancer. Detailed results from this study are expected to be presented at an upcoming conference.
Exact Sciences is collaborating with the US National Surgical Adjuvant Breast and Bowel Project to conduct additional validation trials, aiming to broaden Oncodetect's applicability across various cancer types. Ongoing trials include the CORRECT-I (NCT06398743) and the pivotal CORRECT-II trial (NCT05210283), both focusing on the correlation between ctDNA and recurrence at specific post-surgical time points in patients with stage II and III colorectal cancer.
Expert Commentary
Takayuki Yoshino, an investigator for the Alpha-CORRECT trial, commented, "There is a critical need to better understand and monitor for residual cancer following surgery. The Oncodetect test represents an exciting development in the field...and look forward to sharing further insights in the coming months."
Launch and Medicare Coverage
Exact Sciences anticipates launching the Oncodetect test in Q2 2025, with Medicare coverage already secured. This will facilitate access to this advanced MRD testing for a broader patient population.
