What question did this study set out to answer?

The study aims to assess the diagnostic performance of Oncuria-Detect for detecting bladder cancer in patients with microscopic hematuria.

May 11, 2026Open Access

Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study

Key Points

The study aims to assess the diagnostic performance of Oncuria-Detect for detecting bladder cancer in patients with microscopic hematuria.
Prospective, multicenter study conducted from September 2018 to July 2025 across 9 facilities in the US and Japan.
321 participants were enrolled, with 292 deemed eligible; pre-cystoscopy urine samples were analyzed using Oncuria-Detect, BladderChek™, and urine cytology.
Cystoscopy with biopsy was used as the reference standard for bladder cancer diagnosis.
Bladder cancer was diagnosed in 22 patients (7.5%).
Oncuria-Detect had 82.0% sensitivity and 97.5% negative predictive value, outperforming BladderChek™ (9.3% sensitivity) and cytology (44.8% sensitivity).
High-grade sensitivity for Oncuria-Detect was 93.5% and for muscle-invasive bladder cancer (MIBC) it was 100.0%, significantly higher than BladderChek™ and cytology.

Abstract

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 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/urothelial cancer in patients with microscopic hematuria. Methods From September 2018 through July 2025, 9 medical facilities in the US and Japan prospectively enrolled 321 participants of whom 292 were deemed eligible. 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 and 97.5% negative predictive value (NPV) compared to BladderChek™ (9.3% sensitivity and 95.4% NPV) and cytology (44.8% sensitivity and 97.2% NPV). Oncuria-Detect displayed favorable sensitivity for identifying early- and late-stage cancer. Oncuria-Detect had a favourable performance in detecting high-grade and MIBC (i.e., aggressive cancers); high-grade sensitivity was 93.5% (95%CI: 0.783–1.000) and MIBC sensitivity was 100.0% (95%CI: 1.000–1.000) compared to BladderChek™ high-grade sensitivity of 13.8% (95%CI: 0.000–0.370) and MIBC sensitivity was 0.0% (95%CI: 0.000–0.000) and cytology high-grade sensitivity was 60.1% (95%CI: 0.333–0.852) and MIBC sensitivity was 73.9% (95%CI: 0.000–1.000). Conclusions In this 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. Clinical trial number Clinicaltrials.gov NCT03193541.

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