Abstract 1917: Validation of Oncuria for the early detection of bladder cancer
Authors: Lynne Wilkens, Loic Le Marchand, Gong Yang, Jian-Min Yuan, Martha Shrubsole, Michael Luu, Ian Pagano, Sunao Tanaka, Hideki Furuya, Charles J. Rosser
Journal: Cancer Research (2025)

Objectives: Longitudinal multi-marker combinations have the potential to improve sensitivity while maintaining the high specificity required for early detection of bladder cancer, i.e. before the development of symptoms. Our objective was to identify a multi-marker panel suitable for bladder cancer, where each individual marker has its own baseline, permitting longitudinal algorithm development. Materials and Methods: In this multicenter case-control study, we measured the 10 protein biomarkers associated with Oncuria (ANG, APE, A1AT, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGF) in mid-stream spot voided urine samples from 247 subjects who would go on to develop bladder cancer in the ensuring 3-60 months and 247 matched controls. Statistical analyses included: reporting mean/median of the biomarkers, bootstrapping analysis, regression analysis with the biomarkers as explanatory variables, logistic regression analysis to generate the nonparametric receiver operating characteristic (ROC) curve for each biomarker and using a generalized estimating equation (GEE) model to depict difference between biomarkers from cancer and control subjects at the varying time points. Results: Urinary concentrations of all 10 biomarkers were elevated in patients who went on to develop bladder cancer compared with non-bladder cancer with significance approached in all biomarkers except MMP10. Furthermore, the following biomarkers were significant elevated in bladder cancer subjects vs controls at 12 months prior to bladder cancer presentation; angiogenin at 12 months (p=0.008), APOE at 12 months (p&amp;lt;0.001), CA9 at 12 months (p=0.010), MMP10 at 12 months (p=0.002), MMP9 at 12 months (p=0.011), PAI1 at 12 months (p=0.005), SDC1 at 12 months (p=0.003), and VEGF at 12 months (p=&amp;lt;0.001). IL8 approached significance at 12 months (p=0.067) while A1AT approached significance at 24 months (p=0.070). Conclusions: In this case-control multicenter study assessing 10 protein biomarkers in voided urine, we found clinically relevant differences in 9 of the 10 biomarkers 12-60 months prior to bladder cancer subjects developing cancer compared to matched controls. Therefore, this multiplex urine-based immunoassay test holds promise for facilitating the early detection of bladder cancer in at risk patients, i.e., heavy smokers (&amp;gt;20 pack-year history) over the age of 50 years and help to identify early stage cancers when they are more amenable to our current treatment strategies. Citation Format: Lynne Wilkens, Loic Le Marchand, Gong Yang, Jian-Min Yuan, Martha Shrubsole, Michael Luu, Ian Pagano, Sunao Tanaka, Hideki Furuya, Charles J. Rosser. Validation of Oncuria for the early detection of bladder cancer [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 1917.