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Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer
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-inv...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025333/ https://www.ncbi.nlm.nih.gov/pubmed/33823873 http://dx.doi.org/10.1186/s12967-021-02796-4 |
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author | Hirasawa, Yosuke Pagano, Ian Chen, Runpu Sun, Yijun Dai, Yunfeng Gupta, Amit Tikhonenkov, Sergei Goodison, Steve Rosser, Charles J. Furuya, Hideki |
author_facet | Hirasawa, Yosuke Pagano, Ian Chen, Runpu Sun, Yijun Dai, Yunfeng Gupta, Amit Tikhonenkov, Sergei Goodison, Steve Rosser, Charles J. Furuya, Hideki |
author_sort | Hirasawa, Yosuke |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12967-021-02796-4. |
format | Online Article Text |
id | pubmed-8025333 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-80253332021-04-07 Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer Hirasawa, Yosuke Pagano, Ian Chen, Runpu Sun, Yijun Dai, Yunfeng Gupta, Amit Tikhonenkov, Sergei Goodison, Steve Rosser, Charles J. Furuya, Hideki J Transl Med Research 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12967-021-02796-4. BioMed Central 2021-04-06 /pmc/articles/PMC8025333/ /pubmed/33823873 http://dx.doi.org/10.1186/s12967-021-02796-4 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Hirasawa, Yosuke Pagano, Ian Chen, Runpu Sun, Yijun Dai, Yunfeng Gupta, Amit Tikhonenkov, Sergei Goodison, Steve Rosser, Charles J. Furuya, Hideki Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer |
title | Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer |
title_full | Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer |
title_fullStr | Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer |
title_full_unstemmed | Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer |
title_short | Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer |
title_sort | diagnostic performance of oncuria™, a urinalysis test for bladder cancer |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025333/ https://www.ncbi.nlm.nih.gov/pubmed/33823873 http://dx.doi.org/10.1186/s12967-021-02796-4 |
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