Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect, interim analysis of an international prospective study

Background - Microscopic hematuria occurs in up to 10% of the general population and initiates costly evaluation to ensure no bladder cancer exists. Oncuria-Detect is a 10-plex immunoassay that detects de novo bladder cancer by generating a protein biomarker signature from a single voided urine sample. This report details the interim analysis of our prospective study that compares the diagnostic performance of the multiplex Oncuria-Detect assay to that of the single-analyte ( i.e. , NMP22) BladderChek urine assay and urine cytology for identifying bladder cancer in patients with microscopic hematuria. Methods - From September 2018 through July 2025, 9 medical facilities in the US and Japan prospectively enrolled 292 eligible patients (~30%) of the proposed 900 patients with microscopic hematuria into this study. The bladder cancer diagnostic reference standard was cystoscopy with biopsy. Pre-cystoscopy, patients provided a urine sample for analysis by Oncuria-Detect and BladderChek (analyzed in a blinded manner) as well as urine cytology. Results - Bladder cancer was diagnosed in 22 patients (7.5%). The Oncuria-Detect assay had the following performance characteristics 82.0% sensitivity, 37.8% specificity, 97.5% adjusted negative predictive value (NPV) compared to BladderChek (9.3% sensitivity, 99.6% specificity, 95.4% adjusted NPV) and cytology (44.8% sensitivity, 99.3% specificity, 97.2% adjusted NPV). Oncuria-Detect displayed better sensitivity than BladderChek and cytology for identifying early- and late-stage cancer. Conclusions - In this interim analysis of an international prospective trial, Oncuria-Detect performed favorably in the non-invasive evaluation of bladder cancer presence in patients presenting with microscopic hematuria.