Diagnostic Accuracy of the Oncuria-Detect Multiplex Immunoassay in Detecting Upper Tract Urothelial Carcinoma
- bgtaylor1
- Feb 24
- 2 min read
Date: | February 2026 |
PMID: | |
Category: | N/A |
Authors: | Kazutoshi Fujita, Makito Miyake, Mamoru Hashimoto, Takuto Shimizu, Jennifer Linehan, Joshua Gottlieb, Ian Pagano, Sergei Tikhonenkov, Michael Luu, Sunao Tanaka, Fernando Siguencia, Kaoru Murakami, Riko Lee, Toru Sakatani, Charles J Rosser, Hideki Furuya |
DOI: |
Purpose: Urine-based assays currently have a limited role in the management of patients with upper tract urothelial carcinoma (UTUC) because of insufficient accuracy. This study evaluated a multiplex urine assay designed to accurately and noninvasively diagnose UTUC.
Materials and methods: Oncuria-Detect is a multiplex immunoassay capable of detecting urothelial cancer using a single voided urine specimen. In the current multi-institutional study, we tested the assay's utility in identifying UTUC in 60 subjects presenting for evaluation of upper tract mass compared with samples from 60 age-, sex-, and race-matched controls. Cancer status was confirmed by histopathological assessment of tissue specimens obtained during ureteroscopy/biopsy or at the time of definitive surgical intervention (nephroureterectomy or ureterectomy).
Results: For detecting UTUC, Oncuria-Detect provided an AUC of 0.77 (95% CI: 0.70-0.84) with an overall sensitivity of 93%, specificity of 55%, negative predictive value 89%, and positive predictive value 67%. Assay sensitivity values for low-grade, high-grade, noninvasive, and invasive UTUC were 94%, 93%, 93%, and 92%, respectively. Voided urine cytology showed an overall sensitivity of 54%, specificity of 100%, negative predictive value 31.0%, and positive predictive value 100%. Selective (upper tract) cytology had a sensitivity of 80%. Oncuria-Detect outperformed both noninvasive voided urinary cytology and invasive selective cytology in overall assay performance.
Conclusions: Oncuria-Detect accurately identified and categorized UTUC and discriminated patients with cancer from nontumor-bearing individuals. The Oncuria-Detect test provides a rapid, accurate, and noninvasive method for detecting UTUC.
Acknowledgements:
The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute, or the National Institute of Health.
The Translational and Basic Science Research in Early Lesions (TBEL) Research Consortia is supported and funded by grants from the National Cancer Institute and the National Institutes of Health under the following award numbers:
Project Number: | Awardee Organization |
U54CA274374 | Fred Hutchinson Cancer Center |
U54CA274375 | Houston Methodist Research Institute |
U54CA274370 | Johns Hopkins University |
U54CA274371 | UT MD Anderson Cancer Center |
U54CA274367 | Vanderbilt University Medical Center |
Comments