Prospective multicenter validation of a Urine-Based multiplex assay for risk stratification of patients presenting with gross hematuria
Year: 2026
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Cystoscopy is the standard-of-care for evaluating patients with gross hematuria (GH), the primary sign of urothelial cancer (UC). To investigate whether Oncuria-Detect can improve detection of UC while evaluating participants with GH. METHODS: From September 2016 through July 2025, 9 academic, private practice, and hospital facilities in the US and Japan prospectively enrolled 450 participants with GH. Prior to the cystoscopic/ureteroscopic evaluation, participants provided a urine sample for Oncuria-Detect and BladderChek™, as well as urine cytology. The diagnostic performance parameters of Oncuria-Detect was compared with BladderChek™ and urine cytology as an aid for detecting de novo UC with cystoscopy/ureteroscopy and histological evaluation. RESULTS: UC was diagnosed in 97 of 450 participants. The Oncuria-Detect assay was positive in 80 of 97 participants with UC resulting in a sensitivity of 82.6% (95%CI, 74.9%-89.6%) and 87.2% negative predictive value (NPV) (95%CI, 83.8%-93.0%). BladderChek™ results were positive in 16 of 97 participants resulting in a sensitivity of 16.4% (95%CI, 10.0%-23.5%) and 80.8% NPV (95%CI, 81.5%-83.8%). Cytology test results were positive in 35 of 97 participants with a sensitivity of 35.7% (95%CI, 26.5%-46.1%) and 84.6% NPV (95%CI, 84.5-88.1). Oncuria-Detect sensitivity remained relatively high all grades and all stages. The number needed to evaluate to detect one UC was 5 for cystoscopy compared to 6 for Oncuria-Monitor, 29 for BladderChek™ and 13 for cytology. CONCLUSIONS: In this prospective trial, Oncuria-Detect demonstrated significantly higher sensitivity for detecting de novo UC than comparator urine tests, supporting its potential as a non-invasive risk stratification tool for patients presenting with GH. FUNDING: This work was supported by NIH/NCI research grants UH3 CA271377 (CJR), R01 CA277810 (HF/CJR), R01 CA198887 (CJR) and U54 CA274375-01 (HF/CJR). CLINICALTRIALS.GOV: NCT03193528.
DOI: 10.1093/jnci/djag282
Institutions: The University of Texas Southwestern Medical Center, Nara Medical University, Nara Prefecture Seiwa Medical Center, Cedars-Sinai Medical Center, University of Rochester Medicine, University of California, Los Angeles, Fred Hutch Cancer Center, University of Hawaii Cancer Center, Johns Hopkins University, Johns Hopkins Medicine, Tower Urology Medical Group, Nonagen Bioscience (United States)
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,436
OpenAlex ID: W7203701919
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