Bladder cancer is the 9th most diagnosed cancer worldwide with high incidences reported in Europe and the United States. Here, we evaluated the real-world performance of a commercially available multiplex immunoassay (Oncuria-Detect, Nonagen Bioscience Corp, Los Angeles, CA, USA) that detects bladder cancer by simultaneously measuring a panel of 10 protein biomarkers in naturally voided urine samples.
We tested prospectively collected urine samples from a real-world cohort of 931 patients presenting to five US centres, one European centre and one Japanese centre with haematuria, in addition to 69 patients with either kidney or prostate cancer (disease controls). The algorithm training/refinement set comprised 617 subjects and the test set included 383 subjects. Assay results were collated with patient clinical data and a cancer diagnosis was defined by biopsy and pathology. The prevalence of bladder cancer in the study was 20%.
In the training set, the Oncuria-Detect assay correctly identified bladder cancer in 105 of 121 cases. In the test set, the Oncuria-Detect assay correctly identified bladder cancer in 62 of 73 cases resulting in a sensitivity of 85%, a specificity of 72%, and a negative predictive value (NPV) of 95%. The performance of Oncuria was similar for both low-grade/low-stage and high-grade/high-stage.
The multiplex Oncuria assay identified bladder cancer with high sensitivity and NPV. Oncuria's high NPV could effectively rule out 66% of patients from requiring subsequent cystoscopy.
Journal of translational medicine. 2025 Jun 18*** epublish ***
Ian Pagano, Zhen Zhang, Michael Luu, Sergei Tikhonenkov, Florence Le Calvez-Kelm, Steve Goodison, Toru Sakatani, Kaoru Murakami, Takashi Kobayashi, Patrice Avogbe, Howard Kim, Riko Lee, Arnaud Manel, Emmanuel Vian, Charles J Rosser, Hideki Furuya
Population Sciences in the Pacific Program, University of Hawaii Cancer Center, Honolulu, HI, USA., Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD, USA., Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, USA., Translational and Clinical Program, University of Hawaii Cancer Center, Honolulu, HI, USA., International Agency for Research On Cancer, Lyon, France., Quantitative Health Sciences, Mayo Clinic Florida, Jacksonville, FL, USA., Department of Urology, Kyoto University, Kyoto, Japan., Department of Urology, Cedars Sinai Medical Center, Los Angeles, CA, USA., Le Creusot Hospital, Le Creusot, France., Urology Department, Protestant Clinic of Lyon, Lyon, France., Department of Biomedical Science, Cedars-Sinai Medical Center, 110 N. George Burns Road, Davis 2025, Los Angeles, CA, 90048, USA. .