Detection of bladder cancer in patients with gross hematuria using Oncuria-Detect, a urine-based multiplex immunoassay

Background - Cystoscopy is standard of care in evaluating patients with gross hematuria for bladder cancer with hematuria being the primary sign of bladder cancer. Oncuria-Detect, a liquid biopsy to detect de novo bladder cancer from a single voided urine sample demonstrated favorable performance. Methods - To investigate whether Oncuria-Detect, a multiplex immunoassay that detects a urothelial cancer associated diagnostic signature composed of 10 proteins in voided urine could improve detection of urothelial cancer while evaluating participants with gross hematuria. From September 2016 through July 2025, 9 academic, private practice, and hospital facilities in the US and Japan prospectively enrolled 450 participants with gross hematuria into this urothelial cancer evaluation study. Diagnosis of urothelial cancer was based on cystoscopy (or ureteroscopy) with biopsy, which is accepted as the reference standard. Prior to the cystoscopic/ureteroscopic evaluation, participants provided a urine sample for analysis of Oncuria-Detect and BladderChek (analyzed in a blinded manner) as well as urine cytology. The performance of Oncuria-Detect was compared with BladderChek and urine cytology as an aid to detect de novo urothelial cancer with cystoscopy/ureteroscopy and histological evaluation. Results - Urothelial cancer was diagnosed in 97 participants (4 of whom had upper tract urothelial carcinoma and 93 with urothelial carcinoma of the bladder). The Oncuria-Detect assay was positive in 80 of 97 participants with cancer resulting in a sensitivity of 82.6% (95% CI, 74.9%-89.6%) with a specificity of 33.3% (95% CI, 28.7%-38.7%) and 88.4% adjusted negative predictive value (NPV) (95% CI, 83.8%-93.0%). BladderChek results were positive in 16 of 97 participants resulting in a sensitivity, 16.4% (95% CI, 10.0%-23.5%) with a specificity of 99.2% (95% CI, 98.0%-100.0%) and 82.6% adjusted NPV (95% CI, 81.5%-83.7%), whereas cytology test results were positive in 35 of 97 participants with a noted sensitivity of 35.7% (95% CI, 26.5%-46.1%) at a specificity of 99.7% (95% CI, 99.1%-100.0%) and 86.1% adjusted NPV (95% CI 84.4-88.1). Oncuria-Detect sensitivity remained high for low-grade 81.7% (95% CI, 67.2%-94.7%) vs . high grade 82.7% (95% CI, 74.2%-90.9%) and NMIBC 82.9% (95% CI, 74.4%-90.8%) vs. MIBC 79.8% (95% CI, 61.3%-94.7%). Conclusions - In this large prospective trial, Oncuria-Detect, had a substantially superior sensitivity compared to both BladderChek and urinary cytology in detecting de novo urothelial cancers, allowing it to effectively rule out approximately 30% of individuals presenting for gross hematuria evaluation.