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

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

doi:10.1186/s12967-026-08245-4

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

J Transl Med. 2026 May 9. doi: 10.1186/s12967-026-08245-4. Online ahead of print.

Authors

Yair Lotan¹, Satoshi Anai², Howard Kim³, Greg Gin⁴, Arash Akhavein³, Makito Miyake⁵, Michael Luu⁶, Michael Ahdoot³, Edward Messing⁷, Garry Peers⁸, Andrew Chen³, Ariel Moradzadeh³, Arnold I Chin⁹, Menghan Liu¹⁰, Sunao Tanaka⁶, Sergei Tikhonekov^{11

12}, Ian Pagano¹³, Yingye Zheng⁹, Zhen Zhang¹⁴, Hideki Furuya^#⁶, Charles J Rosser^#^{15

16}

Affiliations

¹ Department of Urology, University of Texas Southwestern, Dallas, TX, USA.
² Seiwa Medical Center, Nara, Japan.
³ Department of Urology, Cedars-Sinai Medical Center, 110 N. George Burns Rd, Davis 2025, Los Angeles, CA, 90048, USA.
⁴ VA Hospital Long Beach, Long Beach, CA, USA.
⁵ Nara Medical University, Nara, Japan.
⁶ Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁷ Department of Urology, University of Rochester Medical Center, Rochester, NY, USA.
⁸ Aloha Urology, Honolulu, HI, USA.
⁹ University of California Los Angeles (UCLA), Los Angeles, CA, USA.
¹⁰ Fred Hutchinson Cancer Center, Seattle, WA, USA.
¹¹ Island Urology, Honolulu, HI, USA.
¹² Translational and Clinical Program, University of Hawaii Cancer Center, Honolulu, HI, USA.
¹³ Cancer Prevention in Pacific Program, University of Hawaii Cancer Center, Honolulu, HI, USA.
¹⁴ Department of Pathology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
¹⁵ Department of Urology, Cedars-Sinai Medical Center, 110 N. George Burns Rd, Davis 2025, Los Angeles, CA, 90048, USA. charles.rosser@cshs.org.
¹⁶ Nonagen Bioscience Corp., Los Angeles, CA, USA. charles.rosser@cshs.org.

^# Contributed equally.

PMID: 42106837
DOI: 10.1186/s12967-026-08245-4

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.

Keywords: Bladder cancer; Detection; Microscopic hematuria; Urine.

Associated data

ClinicalTrials.gov/NCT03193541