Kim, Howard

Abstract Background and Objective: 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 that detects bladder cancer by simultaneously measuring a panel of 10 biomarker proteins in naturally voided urine samples. Methods: We tested prospectively collected urine samples from a real-world cohort of 1, 002 patients presenting to five USA centers, one European center and one Japanese center with hematuria. 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 cohort was 15.9%. Results: In a training set (n=684), the Oncuria-Detect assay correctly identified bladder cancer in 94/109 cases, representing a sensitivity of 91.8%, specificity of 71.6% (AUC 0.885; 95% CI 0.843 - 0.927) and with improved performance for high-grade bladder cancer and muscle-invasive bladder cancer (sensitivity 93.6% and 92.1%, respectively). In a test cohort of n =339 the AUC for detecting bladder cancer was 0.850 (95% CI 0.779-0.920). Conclusions and Implications: The multiplex Oncuria-Detect assay identified bladder cancer with high sensitivity and NPV, for low-grade and high-grade tumors alike. Oncuria-Detect’s high NPV could effectively rule out 66% of patients from requiring subsequent cystoscopy. Citation Format: Ian Pagano, Zhen Zhang, Sergei Tikhonenkov, Florence Le Calvez-Kelm, Steve Goodison, Toru Sakatani, Kaoru Murakami, Takashi Kobayashi, Howard Kim, Riko Lee, Sunao Tanaka, Charles J. Rosser, Hideki Furuya. Performance of the Oncuria-detect bladder cancer test for evaluating patients presenting with hematuria: results from a real-world clinical setting [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 5919.

Abstract Bladder cancer is the 9th most diagnosed cancer worldwide with higher incidences reported in Europe and the United States. Here, we evaluate the performance of a novel, commercially available multiplex immunoassay querying for 10 proteins associated with a bladder cancer diagnostic signature (Oncuria®-Detect, Nonagen Bioscience Corp, Los Angeles, CA, US) for the detection of de novo bladder cancer, in a large prospectively collected real world cohort comprised of 995 patients, across seven centers, presenting with hematuria. The results were compared with the patients’ clinical data and final diagnosis as defined by the results of cystoscopy, with a prevalence of bladder cancer of 15.9%. In the test cohort, Oncuria®-Detect detected bladder tumors in 94/109 cancers, giving overall sensitivity of 86.2% and an overall negative predictive value (NPV) of 96.7% with corresponding specificity of 80.2% with favorable performance characteristics in high grade bladder cancer and muscle-invasive bladder cancer. Patient summary: We conducted a large cross-sectional clinical study for detecting de novo bladder cancer with a novel, simple urine test (Oncuria®-Detect), which measures 10 bladder cancer associated proteins in a single voided urine sample. We analyzed urines from 995 patients and demonstrated that the new urine test can detect bladder cancer with a high degree of accuracy, specifically in patients with high grade or high stage disease. In conclusion, the novel Oncuria®-Detect urine test can be used to help detect new bladder cancers. Citation Format: Ian Pagano, Sergei Tikhonenkov, Florence Le Calvez-Kelm, Steve Goodison, Zhen Zhang, Toru Sakatani, Kaoru Murakami, Howard Kim, Riko Lee, Sunao Tanaka, Charles J Rosser, Hideki Furuya. Performance of the Oncuria®-Detect test for the evaluation of patients presenting with hematuria: Results from a real world clinical setting [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr A071.