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.
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.
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).
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.
Clinicaltrials.gov NCT03193541.
Journal of translational medicine. 2026 May 09 [Epub ahead of print]
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
Department of Urology, University of Texas Southwestern, Dallas, TX, USA., Seiwa Medical Center, Nara, Japan., Department of Urology, Cedars-Sinai Medical Center, 110 N. George Burns Rd, Davis 2025, Los Angeles, CA, 90048, USA., VA Hospital Long Beach, Long Beach, CA, USA., Nara Medical University, Nara, Japan., Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Department of Urology, University of Rochester Medical Center, Rochester, NY, USA., Aloha Urology, Honolulu, HI, USA., University of California Los Angeles (UCLA), Los Angeles, CA, USA., Fred Hutchinson Cancer Center, Seattle, WA, USA., Island Urology, Honolulu, HI, USA., Cancer Prevention in Pacific Program, University of Hawaii Cancer Center, Honolulu, HI, USA., Department of Pathology, Johns Hopkins School of Medicine, Baltimore, MD, USA., Department of Urology, Cedars-Sinai Medical Center, 110 N. George Burns Rd, Davis 2025, Los Angeles, CA, 90048, USA. .
PubMed http://www.ncbi.nlm.nih.gov/pubmed/42106837