Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer

Abstract

Background Due to insufficient accuracy, urine-based assays currently have a limited role in the management of patients with bladder cancer. The identification of multiplex molecular signatures associated with disease has the potential to address this deficiency and to assist with accurate, non-invasive diagnosis and monitoring. Methods To evaluate the performance of Oncuria™, a multiplex immunoassay for bladder detection in voided urine samples. The test was evaluated in a multi-institutional cohort of 362 prospectively collected subjects presenting for bladder cancer evaluation. The parallel measurement of 10 biomarkers (A1AT, APOE, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGFA) was performed in an independent clinical laboratory. The ability of the test to identify patients harboring bladder cancer was assessed. Bladder cancer status was confirmed by cystoscopy and tissue biopsy. The association of biomarkers and demographic factors was evaluated using linear discriminant analysis (LDA) and predictive models were derived using supervised learning and cross-validation analyses. Diagnostic performance was assessed using ROC curves. Results The combination of the 10 biomarkers provided an AUROC 0.93 [95% CI 0.87–0.98], outperforming any single biomarker. The addition of demographic data (age, sex, and race) into a hybrid signature improved the diagnostic performance AUROC 0.95 [95% CI 0.90–1.00]. The hybrid signature achieved an overall sensitivity of 0.93, specificity of 0.93, PPV of 0.65 and NPV of 0.99 for bladder cancer classification. Sensitivity values of the diagnostic panel for high-grade bladder cancer, low-grade bladder cancer, MIBC and NMIBC were 0.94, 0.89, 0.97 and 0.93, respectively. Conclusions Urinary levels of a biomarker panel enabled the accurate discrimination of bladder cancer patients and controls. The multiplex Oncuria™ test can achieve the efficient and accurate detection and monitoring of bladder cancer in a non-invasive patient setting.

Identification of ferroptosis‐related genes as potential biomarkers of tongue squamous cell carcinoma using an integrated bioinformatics approach

“…Other studies have verified the predictive value of the genes used in our prediction model. CA9 can not only be used as a prognostic marker for bladder cancer [40], previous studies have shown that high CA9 expression is associated with poor prognosis of TSCC [41]. Moreover, CA9 confers resistance to ferroptosis in malignant mesothelioma under hypoxia [42].…”

Clinical Utility of Oncuria™, a Multiplexed Liquid Biopsy for the Non-Invasive Detection of Bladder Cancer—A Pilot Study

“…The moderator took detailed notes of each encounter (quantitative and qualitative) with a focus on each participant's responses to the questions. Prior to the Zoom interview, participants were asked to read two recently published articles describing the analytical validation of Oncuria™ [4] and the clinical validation of Oncuria™ [6] to provide context to some of the questions in the clinical vignettes (Supplementary File S1). Each participant evaluated the same 9 clinical vignettes.…”

The Role of New Technologies in the Diagnosis and Surveillance of Non-Muscle Invasive Bladder Carcinoma: A Prospective, Double-Blinded, Monocentric Study of the XPERT© Bladder Cancer Monitor and Narrow Band Imaging© Cystoscopy

“…Initial testing in patients suspected of having BC (48 of 71 patients with BC including carcinoma in situ) resulted in a SE of 100% and SP of 92% (PPV and NPV of 97.5% and 100%, respectively). Oncuria© is a multiplex immunoassay that detects the biomarkers A1AT, APOE, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGFA, and also showed promising results in 46 de novo BC patients compared with non-cancer controls, with a reported SE and SP of 0.93 each and PPV and NPV of 65% and 99%, respectively [14]. However, both Uro17© and Oncuria© have not yet been evaluated in the follow-up/surveillance setting.…”

“…Other promising technologies include the milieu of novel markers in the urine, such as enzyme immunoassays (NMP22©; Alere, Waltham, MA, USA), H-related proteins (BTA STAT ® and BTA TRAK©; Polymedico, Cortlandt, NY, USA), immunohistochemical assays (ImmunoCyt/uCyt+©; Scimedex, Dover, NJ, USA), fluorescence in situ hybridization (UroVysion©; Abbott, Chicago, IL, USA), multiplex immunoassays (Oncuria©; Nonagen Bioscience, Jacksonville, FL, USA), oncoproteins (Uro17©; Accupath, Plainview, NY, USA), and mRNA (Cxbladder©; Pacific Edge, Hummelstown, PA, USA) [12][13][14][15][16][17][18].…”