ArticleJournal of translational medicine2021
Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer.
Article in Journal of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.
- Noninvasive Tests for Bladder Cancer Detection and Surveillance: A Systematic Review of Commercially Available Assays.Bladder cancer (Amsterdam, Netherlands) · 2024Pooled it
- Clinical Validation of a Multiplex Urine Biomarker Assay for Surveillance of Recurrent Bladder Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- A multi-modal approach for decision making in bladder cancer.Nature reviews. Urology · 2026Review
- Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study.Journal of translational medicine · 2026Article
- Advances in the management of localized bladder cancers.Nature reviews. Clinical oncology · 2026Review
- Diagnostic Accuracy of the Oncuria-Detect Multiplex Immunoassay in Detecting Upper Tract Urothelial Carcinoma.The Journal of urology · 2026Article
- Emerging Molecular and Computational Biomarkers in Urothelial Carcinoma: Innovations in Diagnosis, Prognosis, and Therapeutic Response Prediction.Journal of personalized medicine · 2026Review
- Hematuria Cancer Risk Score in Combination With Oncuria-Detect for Patients Undergoing Evaluation for Hematuria.Urology · 2026Article
- Developing a prediction model in a large case-control study for the early detection of bladder cancer.Journal of translational medicine · 2025Article
- Urinary biomarkers in multicentric studies: Shaping the future of bladder cancer diagnosis and follow-up.BJUI compass · 2025Review
- Low-grade non-muscle-invasive bladder cancer: molecular landscape, treatment strategies and emerging therapies.Nature reviews. Urology · 2025Review
- Expanded Performance Comparison of the Oncuria 10-Plex Bladder Cancer Urine Assay Using Three Different Luminex xMAP Instruments.Diagnostics (Basel, Switzerland) · 2025Article
- Performance of the Oncuria-Detect bladder cancer test for evaluating patients presenting with haematuria: results from a real-world clinical setting.Journal of translational medicine · 2025Article
- Effects of Different Voided Urine Sample Storage Time, Temperature, and Preservatives on Analysis with Multiplex Bead-Based Oncuria Bladder Cancer Immunoassay.Diagnostics (Basel, Switzerland) · 2025Article
- A Machine Learning Computational Framework Develops a Multiple Programmed Cell Death Index for Improving Clinical Outcomes in Bladder Cancer.Biochemical genetics · 2024Article
- Microsatellite Instability in Urine: Breakthrough Method for Bladder Cancer Identification.Biomedicines · 2024Review
- Single center evaluation of sensitivity and specificity of CellDetect assay in early bladder cancer patients.Scientific reports · 2024Article
- Urine scRNAseq reveals new insights into the bladder tumor immune microenvironment.The Journal of experimental medicine · 2024Article
- Current smartphone-assisted point-of-care cancer detection: Towards supporting personalized cancer monitoring.Trends in analytical chemistry : TRAC · 2024Article
- New Perspectives on the Role of Liquid Biopsy in Bladder Cancer: Applicability to Precision Medicine.Cancers · 2024Review
Corrections and comments
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Authors and funding
10 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundDue 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.
methodsTo 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.
resultsThe 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.
conclusionsUrinary 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.