Performance of the Oncuria-Detect bladder cancer test for evaluating patients presenting with haematuria: results from a real-world clinical setting

作者：Ian Pagano, Zhen Zhang, Michael Luu, Sergei Tikhonenkov, Florence Le Calvez‐Kelm, Steve Goodison, Toru Sakatani, Kaoru Murakami, Takashi Kobayashi, Patrice Hodonou Avogbe, Howard Kim, Riko Lee, Arnaud Manel, E. Vian, Charles J. Rosser, Hideki Furuya · 发表于：Journal of Translational Medicine · 年份：2025 · DOI：10.1186/s12967-025-06749-z · 被引用次数：8 · 研究领域：Bladder and Urothelial Cancer Treatments、Parasitic Diseases Research and Treatment、Paleopathology and ancient diseases

BACKGROUND: 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. METHODS: 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%. RESULTS: 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. CONCLUSIONS: The multiplex Oncuria assay identified bladder cancer with high sensitivity and NPV. Oncuria's high NPV could effectiv...