Exact Sciences, has shared results from a trial of its Oncodetect test which is designed to identify the last remaining cells post-cancer treatment.
Results from the Wisconsin-based company’s Alpha-CORRECT study showed that the Oncodetect test achieved a 78% sensitivity in post-surgical checks and a 91% sensitivity during the surveillance monitoring period, with specificities of 80% and 94%, respectively.
Molecular residual disease (MRD) refers to the presence of tumour-specific DNA in the body remaining in the body, typically after either surgical or chemotherapy treatment, known as circulating tumour DNA (ctDNA). According to Exact Sciences, the Oncodetect test uses whole exome sequencing to detect this DNA.
Brian Baranick, general manager of precision oncology at Exact Sciences, said: “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. 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 US have access to MRD testing.”
The Nasdaq-listed company stated that the diagnostic test also achieved its primary endpoint as part of a second validation study, dubbed the Beta-CORRECT study, a trial examining the association between MRD positivity and recurrence in patients with stage III colon cancer, with results set to be announced at an upcoming conference.
Meanwhile, Exact Sciences has partnered with the US National Surgical Adjuvant Breast and Bowel Project to run multiple additional validation trials with the goal of expanding Oncodetect’s range of indications and tumour types. Among them, it isrunning the CORRECT-I (NCT06398743) study and the pivotal, US-based CORRECT-II trial (NCT05210283). Both trials will examine the association between ctDNA and recurrence at specific post-surgical timepoints in patients with stage II and III colorectal cancer.
An investigator for the Alpha-CORRECT trial, Takayuki Yoshino, added: “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. 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.”
Exact Sciences shared that the Oncodetect test will launch in Q2 2025 with Medicare coverage.
Elsewhere in the world of cancer diagnostics, researchers from the UK’s University of Exeter have developed a method for interpreting standard blood tests designed to advance the detection of lung and bowel cancer. Meanwhile, Biomerica has gained approval from the UAE Ministry of Health and Prevention (MOHAP) for its Fortel prostate-specific antigen (PSA) screening test designed to identify prostate cancer.
