Prospective multicenter validation of a Urine-Based multiplex assay for risk stratification of patients presenting with gross hematuria.

BACKGROUND: Cystoscopy is the standard-of-care for evaluating patients with gross hematuria (GH), the primary sign of urothelial cancer (UC). To investigate whether Oncuria-Detect can improve detection of UC while evaluating participants with GH. METHODS: From September 2016 through July 2025, 9 academic, private practice, and hospital facilities in the US and Japan prospectively enrolled 450 participants with GH. Prior to the cystoscopic/ureteroscopic evaluation, participants provided a urine sample for Oncuria-Detect and BladderChek™, as well as urine cytology. The diagnostic performance parameters of Oncuria-Detect was compared with BladderChek™ and urine cytology as an aid for detecting de novo UC with cystoscopy/ureteroscopy and histological evaluation. RESULTS: UC was diagnosed in 97 of 450 participants. The Oncuria-Detect assay was positive in 80 of 97 participants with UC resulting in a sensitivity of 82.6% (95%CI, 74.9%-89.6%) and 87.2% negative predictive value (NPV) (95%CI, 83.8%-93.0%). BladderChek™ results were positive in 16 of 97 participants resulting in a sensitivity of 16.4% (95%CI, 10.0%-23.5%) and 80.8% NPV (95%CI, 81.5%-83.8%). Cytology test results were positive in 35 of 97 participants with a sensitivity of 35.7% (95%CI, 26.5%-46.1%) and 84.6% NPV (95%CI, 84.5-88.1). Oncuria-Detect sensitivity remained relatively high all grades and all stages. The number needed to evaluate to detect one UC was 5 for cystoscopy compared to 6 for Oncuria-Monitor, 29 for BladderChek™ and 13 for cytology. CONCLUSIONS: In this prospective trial, Oncuria-Detect demonstrated significantly higher sensitivity for detecting de novo UC than comparator urine tests, supporting its potential as a non-invasive risk stratification tool for patients presenting with GH. FUNDING: This work was supported by NIH/NCI research grants UH3 CA271377 (CJR), R01 CA277810 (HF/CJR), R01 CA198887 (CJR) and U54 CA274375-01 (HF/CJR). CLINICALTRIALS.GOV: NCT03193528.