ArticlePractical laboratory medicine2020
Analytical validation of ONCURIA™ a multiplex bead-based immunoassay for the non-invasive bladder cancer detection.
Article in Practical laboratory medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 citing papers in PubMed, 27 citations in OpenAlex.
- 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
- Development and validation of a tumor-derived CXCL1 qPCR assay to support patient selection for anti-CXCL1 therapeutics in bladder cancer.Experimental and molecular pathology · 2026Article
- Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study.Journal of translational medicine · 2026Article
- Diagnostic Accuracy of the Oncuria-Detect Multiplex Immunoassay in Detecting Upper Tract Urothelial Carcinoma.The Journal of urology · 2026Article
- Developing a prediction model in a large case-control study for the early detection of bladder cancer.Journal of translational medicine · 2025Article
- 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
- Urine scRNAseq reveals new insights into the bladder tumor immune microenvironment.The Journal of experimental medicine · 2024Article
- Identification of novel protein biomarkers from the blood and urine for the early diagnosis of bladder cancer via proximity extension analysis.Journal of translational medicine · 2024Article
- Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms.Journal of translational medicine · 2024Article
- Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms.Research square · 2023Article
- Urine biomarkers in bladder cancer - current status and future perspectives.Nature reviews. Urology · 2023Review
- Association of SNPs in the PAI1 Gene with Disease Recurrence and Clinical Outcome in Bladder Cancer.International journal of molecular sciences · 2023Article
- A Diagnostic Gene Expression Signature for Bladder Cancer Can Stratify Cases into Prescribed Molecular Subtypes and Predict Outcome.Diagnostics (Basel, Switzerland) · 2022Article
- Review
- Immunoaffinity monoliths for multiplexed extraction of preterm birth biomarkers from human blood serum in 3D printed microfluidic devices.The Analyst · 2022Article
- Clinical Utility of Oncuria™, a Multiplexed Liquid Biopsy for the Non-Invasive Detection of Bladder Cancer-A Pilot Study.Diagnostics (Basel, Switzerland) · 2022Article
- Application of a multiplex urinalysis test for the prediction of intravesical BCG treatment response: A pilot study.Cancer biomarkers : section A of Disease markers · 2022Article
- Methodologies for the Determination of Blood Alpha1 Antitrypsin Levels: A Systematic Review.Journal of clinical medicine · 2021Review
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe objective of our study was to assess the analytical performance of a multiplex assay (Oncuria™) to quantify protein biomarkers towards a bladder cancer associated diagnostic signature in voided urine.
methodology: Using Luminex xMAP technology, a custom immunoassay was developed to measure the concentrations of 10 urinary analytes (angiogenin, ANG; apolipoprotein E, APOE; alpha-1 antitrypsin, A1AT; carbonic anhydrase 9, CA9; interleukin 8, IL8; matrix metallopeptidase 9, MMP9; matrix metallopeptidase 10, MMP10; plasminogen activator inhibitor 1, PAI1; syndecan 1, SDC1; vascular endothelial growth factor, VEGF). Selectivity, sensitivity, specificity, precision, linearity, dynamic range, and detection threshold were assessed using recombinant proteins and human urine samples. Analytical variability with respect to batch size, run, day, operator, and interference were also evaluated.
resultsAnalytical evaluation demonstrated a) all antigen cross-reactivity was noted to be <1% of the tested concentration, b) minimal detected dose ranged from 0.295 pg/mL in IL8 to 31.1 pg/mL in APOE, c) highly reproducible and accurate noting coefficient of variation (CV) and relative error (RE) values below 15% for all analytes and d) minimal interference. The assay can be completed in <5 h using as little as 150 μL of voided urine.
conclusionTo our knowledge, this is the first multiplex bead-based immunoassay for the non-invasive detection of bladder cancer that has been analytically validated as a tool with the potential to help clinicians manage patients at risk of harboring bladder cancer.
Identifiers
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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.