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Background <p>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 <i>de novo</i> 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.</p> Methods <p>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.</p> Results <p>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).</p> Conclusions <p>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.</p> Clinical trial number <p>Clinicaltrials.gov NCT03193541.</p>

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

  • 期刊论文

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  • 发表日期：

    2026年5月9日

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  • Yair Lotan,
  • Satoshi Anai,
  • Howard Kim,
  • Greg Gin,
  • Arash Akhavein,
  • Makito Miyake,
  • Michael Luu,
  • Michael Ahdoot,
  • Edward Messing,
  • Garry Peers,
  • Andrew Chen,
  • Ariel Moradzadeh,
  • Arnold I. Chin,
  • Menghan Liu,
  • Sunao Tanaka,
  • Sergei Tikhonekov,
  • Ian Pagano,
  • Yingye Zheng,
  • Zhen Zhang,
  • Hideki Furuya,
  • Charles J. Rosser

摘要

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.