Oncocyte Corporation (NASDAQ: OCX), a diagnostics technology leader, announced the publication of favorable data for its DetermaCNI™ assay in Acta Neuropathologica Communications. The study highlights DetermaCNI’s potential as a liquid biopsy method for diagnosing and profiling central nervous system (CNS) tumors via somatic copy number aberrations (SCNAs) in cerebrospinal fluid (CSF).
DetermaCNI™, which measures copy number instability (CNI), a hallmark of cancer, could address a critical need for the nearly 300,000 U.S. patients diagnosed annually with primary brain tumors or brain metastases. Current diagnostics rely on invasive tissue biopsies that pose risks and limited sensitivity. In this study, SCNAs were detected in 10 of 12 patients with CNS cancers, with no SCNAs found in 11 patients with benign or unclear CNS lesions, demonstrating high tumor specificity.
Dr. Ekke Schuetz, Oncocyte’s Chief Science Officer, stated, “This proof-of-principle study suggests DetermaCNI™ could provide significant benefits for patients with brain tumors by enabling molecularly informed diagnoses through a minimally invasive liquid biopsy.”
This assay could offer advantages in tumor classification, heterogeneity mapping, and evolution tracking. Oncocyte views these results as a validation of its R&D efforts and pipeline direction. Alongside its VitaGraft™ and GraftAssure™ transplant tests, Oncocyte plans to commercialize its oncology assays, including DetermaCNI™, within two years to improve patient outcomes and advance molecular diagnostics access.
The study underscores a $300M market opportunity, aiming to revolutionize CNS cancer care.