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

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Yosuke Hirasawa ◽  
Ian Pagano ◽  
Runpu Chen ◽  
Yijun Sun ◽  
Yunfeng Dai ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Diagnostic Performance ◽  
Clinical Laboratory ◽  
Demographic Data ◽  
Roc Curves ◽  
Low Grade ◽  
Linear Discriminant ◽  
Non Invasive ◽  
Diagnostic Panel ◽  
Parallel Measurement

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.

scholarly journals Diagnostic Performance of Oncuria™, a Urinalysis Test for Bladder Cancer

2021 ◽  
Author(s):  
Yosuke Hirasawa ◽  
Ian Pagano ◽  
Runpu Chen ◽  
Yijun Sun ◽  
Yunfeng Dai ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Diagnostic Performance ◽  
Clinical Laboratory ◽  
Demographic Data ◽  
Roc Curves ◽  
Low Grade ◽  
Linear Discriminant ◽  
Non Invasive ◽  
Diagnostic Panel ◽  
Parallel Measurement

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.

scholarly journals MicroRNAs Which Can Prognosticate Aggressiveness of Bladder Cancer

Cancers ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 1551 ◽  
Author(s):  
Edyta Marta Borkowska ◽  
Tomasz Konecki ◽  
Michał Pietrusiński ◽  
Maciej Borowiec ◽  
Zbigniew Jabłonowski
Keyword(s):  
Bladder Cancer ◽  
Area Under The Curve ◽  
Roc Curves ◽  
Control Group ◽  
Low Grade ◽  
Operating Characteristics ◽  
High Death Rate ◽  
Biological Potential ◽  
High Death ◽  
Muscle Invasive

Bladder cancer (BC) is still characterized by a very high death rate in patients with this disease. One of the reasons for this is the lack of adequate markers which could help determine the biological potential of the tumor to develop into its invasive stage. It has been found that some microRNAs (miRNAs) correlate with disease progression. The purpose of this study was to identify which miRNAs can accurately predict the presence of BC and can differentiate low grade (LG) tumors from high grade (HG) tumors. The study included 55 patients with diagnosed bladder cancer and 30 persons belonging to the control group. The expression of seven selected miRNAs was estimated with the real-time PCR technique according to miR-103-5p (for the normalization of the results). Receiver operating characteristics (ROC) curves and the area under the curve (AUC) were used to evaluate the feasibility of using selected markers as biomarkers for detecting BC and discriminating non-muscle invasive BC (NMIBC) from muscle invasive BC (MIBC). For HG tumors, the relevant classifiers are miR-205-5p and miR-20a-5p, whereas miR-205-5p and miR-182-5p are for LG (AUC = 0.964 and AUC = 0.992, respectively). NMIBC patients with LG disease are characterized by significantly higher miR-130b-3p expression values compared to patients in HG tumors.

scholarly journals Non-invasive detection of bladder cancer through the analysis of driver gene mutations and aneuploidy

2017 ◽  
Author(s):  
Simeon Springer ◽  
Maria Del Carmen Rodriguez Pena ◽  
Lu Li ◽  
Christopher Douville ◽  
Yuxuan Wang ◽  
...  
Keyword(s):  
At Risk ◽  
Bladder Cancer ◽  
Gene Mutations ◽  
Urine Samples ◽  
Driver Gene ◽  
Low Grade ◽  
Invasive Approach ◽  
Non Invasive ◽  
Patients At Risk ◽  
Copy Number Changes

AbstractCurrent non-invasive approaches for bladder cancer (BC) detection are suboptimal. We report the development of non-invasive molecular test for BC using DNA recovered from cells shed into urine. This “UroSEEK” test incorporates assays for mutations in 11 genes and copy number changes on 39 chromosome arms. We first evaluated 570 urine samples from patients at risk for BC (microscopic hematuria or dysuria). UroSEEK was positive in 83% of patients that developed BC, but in only 7% of patients who did not develop BC. Combined with cytology, 95% of patients that developed BC were positive. We then evaluated 322 urine samples from patients soon after their BCs had been surgically resected. UroSEEK detected abnormalities in 66% of the urine samples from these patients, sometimes up to 4 years prior to clinical evidence of residual neoplasia, while cytology was positive in only 25% of such urine samples. The advantages of UroSEEK over cytology were particularly evident in low-grade tumors, wherein cytology detected none while UroSEEK detected 67% of 49 cases. These results establish the foundation for a new, non-invasive approach to the detection of BC in patients at risk for initial or recurrent disease.

1779 SURVEILLANCE GUIDELINES FOR LOW GRADE NON-INVASIVE BLADDER CANCER: A COST COMPARISON

2012 ◽  
Vol 187 (4S) ◽  
Author(s):  
Ian Udell ◽  
Raj Kurpad ◽  
Angela Smith ◽  
Michael Woods ◽  
Eric Wallen ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Cost Comparison ◽  
Invasive Bladder Cancer ◽  
Low Grade ◽  
Non Invasive

Comprehensive targeted gene profiling to determine the genomic signature likely to drive progression of high-grade nonmuscle invasive bladder cancer to muscle invasive bladder cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 568-568
Author(s):  
Abedalrhman Alkhateeb ◽  
Govindaraja Atikukke ◽  
Lisa Porter ◽  
Bre-Anne Fifield ◽  
Dora Cavallo-Medved ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Gene Profiling ◽  
Invasive Bladder Cancer ◽  
Low Grade ◽  
Genomic Profiling ◽  
High Grade ◽  
Single Nucleotide Variants ◽  
Muscle Invasive Bladder Cancer ◽  
Non Invasive ◽  
Muscle Invasive

568 Background: Bladder cancer is the fifth most common cancer and eighth leading cause of cancer related-death in North America. It can present as non-muscle invasive bladder cancer (NMIBC) and/or muscle invasive bladder (MIBC). Although genomic profiling studies have established that low-grade NMIBC and MIBC are genetically distinct, high-grade NMIBC can recur and progress to MIBC [ Knowles, M.A. and C.D. Hurst, 2015]. Low grade, non-invasive bladder cancers are characterized by activating mutations in fibroblast growth factor receptor 3 (FGFR3), HRAS or other pathways of receptor kinase activation. High-grade disease, which is often becomes invasive, is characterized by inactivation of TP53 and Rb pathways [Kim, J., et al.]. Finding a subtype of invasive carcinoma with FGFR3 mutation may suggest an alternate pathway by which low grade, non-invasive pathology could transform into invasive disease [Knowles, M.A. and C.D. Hurst, 2015]. Methods: In this study, using a total of 30 bladder cancer (NMIBC and MIBC) patient samples from Windsor Regional Hospital Cancer Program, we performed comprehensive targeted gene sequencing to identify single nucleotide variants, small insertions / deletions, copy number variants and splice variants in over 500 common tumor genes panel. Results: Preliminary data from our study correlates with previously published mutation landscape for NMIBC and MIBC, and includes mutations in EGFR, FGFR3, FGFR4, PIK3CA, CDK6, ALK, JAK, as well as RET. While mutations in AKT1, BRCA1, CCND1, ERBB2, FGFR1, FGFR2, HRAS, and MET appear to be prevalent in NMIBC, mutations in IDH1 and MAP2K2 appear to be more common in MIBC. Three of the samples used in the study are from patients who progressed from high-grade NMIBC to MIBC. Conclusions: Therefore, have the genomic profiling performed at these two stages, which provides a unique ability to identify the potential “genomic triggers” for the transition.

Bladder Tumor Markers: A Review of the Literature

2008 ◽  
Vol 23 (4) ◽  
pp. 249-261 ◽  
Author(s):  
A. Volpe ◽  
M. Racioppi ◽  
D. D'Agostino ◽  
E. Cappa ◽  
M. Gardi ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Prognostic Markers ◽  
Urine Cytology ◽  
Diagnostic Tools ◽  
Low Grade ◽  
Predictive Capacity ◽  
Non Invasive ◽  
Increased Sensitivity ◽  
Muscle Invasive

Bladder cancer is among the top eight most frequent cancers. Its natural history is related to a combination of factors that impact on its aggressiveness. Cystoscopy and urine cytology are the currently used techniques for the diagnosis and surveillance of non-invasive bladder tumors. The sensitivity of urine cytology for diagnosis is not high, particularly in low-grade tumors. The combination of voided urine cytology and new diagnostic urine tests would be ideal for the diagnosis and follow-up of bladder cancer. However, in order to have some clinical utility, new diagnostic and/or prognostic markers should achieve better predictive capacity that the currently used diagnostic tools. None of the markers evaluated over the last years showed remarkable sensitivity or specificity for the identification of any of the diverse types of bladder cancer in clinical practice. The limitations of the known prognostic markers have led to the research of new molecular markers for early detection of bladder cancer. This research focused in particular on the discovery of biomarkers capable of reducing the need for periodic cystoscopies or, ideally, offering a non-invasive examination instead. In this review, we will examine various new markers of bladder cancer and their value in the diagnosis and follow-up of non-muscle-invasive bladder cancer. When compared with urine cytology, which showed the highest specificity, most of these markers demonstrated an increased sensitivity.

scholarly journals A prospective validation of nomograms based on BC-116 and BC-106 urine peptide biomarker panels for bladder cancer diagnostics and monitoring

2021 ◽  
Author(s):  
Lourdes Mengual ◽  
Maria Frantzi ◽  
Marika Mokou ◽  
Mercedes Ingelmo-Torres ◽  
Michiel Vlaming ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Diagnostic Performance ◽  
Cancer Diagnostics ◽  
Urine Samples ◽  
Support Vector ◽  
Biomarker Panel ◽  
Non Invasive ◽  
Urological Disorders ◽  
Improved Performance ◽  
Monitoring Protocols

Purpose: Non-invasive urine-based biomarkers for bladder cancer (BC) diagnosis and surveillance can potentially improve current diagnostic and monitoring protocols by guiding cystoscopy. Here, we aim to access the diagnostic performance of nomograms based on published biomarker panels for BC detection (BC-116) and monitoring of recurrence (BC-106) in combination with cytology, in two prospectively collected patient cohorts. Experimental Design: 602 recruited patients were screened for presence of BC, out of which 551 were found eligible for further analysis. For the primary setting, urine samples from 73 eligible patients were analyzed from those diagnosed with primary BC (n=27) and benign urological disorders (n=46). For the surveillance setting, 478 eligible patients were considered (83 BC recurrences; 395 negative for recurrence). Urine samples were analyzed with capillary electrophoresis coupled to mass spectrometry and the biomarker score was estimated via a support vector machine-based software. Results: Validation of the BC-116 biomarker panel resulted in 89% sensitivity and 67% specificity (AUCBC-116=0.82), similar to the published estimates. The nomogram based on cytology and BC-116 resulted in good (AUCNom116=0.85) but not significantly better performance than the BC-116 alone (P=0.5672). BC-106 biomarker panel showed 89% sensitivity and 32% specificity for surveillance, while improved performance was achieved when a nomogram including BC-106 and cytology was evaluated (AUCNom106=0.82), significantly outperforming both cytology (AUCcyt=0.72;P=0.0022) and BC-106 alone (AUCBC-106=0.67;P=0.0012). Conclusions: BC-116 biomarker panel is a useful test for detecting primary BC. BC-106 classifier integrated with cytology and showing >95% negative predictive value, might be useful for decreasing the number of cystoscopies during surveillance.

Surveillance guidelines for low grade non-invasive bladder cancer: A cost comparison

2012 ◽  
Vol 215 (3) ◽  
pp. S145
Author(s):  
Ian Udell ◽  
Raj Kurpad ◽  
Angela B. Smith ◽  
Michael E. Woods ◽  
Eric Wallen ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Cost Comparison ◽  
Invasive Bladder Cancer ◽  
Low Grade ◽  
Non Invasive
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