Abstract 6514: Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect, interim analysis of an international prospective study

Abstract 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. Citation Format: Sunao Tanaka, Yair Lotan, Makito Miyake, Edward M. Messing, Arnold I. Chin, Menghan Liu, Ian Pagano, Yingye Zheng, Charles Joel Rosser, Zhen Zhang, Hideki Furuya. Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect, interim analysis of an international prospective study abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 6514.