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

Date:	June 18, 2025
PMID:	PMC12178018
Category:	N/A
Authors:	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
Abstract:	40533776

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 effectively rule out 66% of patients from requiring subsequent cystoscopy.

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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