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Article ; Online: Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms

Hideki Furuya / Toru Sakatani / Sunao Tanaka / Kaoru Murakami / Richard T. Waldron / Wayne Hogrefe / Charles J. Rosser

Journal of Translational Medicine, Vol 22, Iss 1, Pp 1-

2024 Volume 9

Abstract: Abstract Background No single marker of bladder cancer (BC) exists in urine samples with sufficient accuracy for disease diagnosis and treatment monitoring. The multiplex Oncuria BC assay noninvasively quantifies the concentration of 10 protein analytes ... ...

Abstract	Abstract Background No single marker of bladder cancer (BC) exists in urine samples with sufficient accuracy for disease diagnosis and treatment monitoring. The multiplex Oncuria BC assay noninvasively quantifies the concentration of 10 protein analytes in voided urine samples to quickly generate a unique molecular profile with proven BC diagnostic and treatment-tracking utility. Test adoption by diagnostic and research laboratories mandates reliably reproducible assay performance across a variety of instrumentation platforms used in different laboratories. Methods We compared the performance of the clinically validated Oncuria BC multiplex immunoassay when data output was generated on three different analyzer systems. Voided urine samples from 36 subjects (18 with BC and 18 Controls) were reacted with Oncuria test reagents in three 96-well microtiter plates on Day 1, and consecutively evaluated on the LED/image-based MagPix, and laser/flow-based Luminex 200 and FlexMap 3D (all xMAP instruments from Luminex Corp., Austin, TX) on Day 2. The BC assay uses magnetic bead-based fluorescence technology (xMAP, Multi-analyte profiling; Luminex) to simultaneously quantify 10 protein analytes in urine specimens [i.e., angiogenin (ANG), apolipoprotein E (ApoE), carbonic anhydrase IX (CA9), CXCL8/interleukin-8 (IL-8), matrix metalloproteinase-9 (MMP-9), matrix metalloproteinase-10 (MMP-10), serpin A1/alpha-1 anti-trypsin (A1AT), serpin E1/plasminogen activator inhibitor-1 (PAI-1), CD138/syndecan-1 (SDC1), and vascular endothelial growth factor-A (VEGF-A)]. All three analyzers quantify fluorescence signals generated by the Oncuria assay. Results All three platforms categorized all 10 analytes in identical samples at nearly identical concentrations, with variance across systems typically < 5%. While the most contemporary instrument, the FlexMap 3D, output higher raw fluorescence values than the two comparator systems, standard curve slopes and analyte concentrations determined in urine samples were concordant across all ...
Keywords	Bladder cancer ; Fluorescence ; Multiplex immunoassay ; Magnetic bead ; In vitro assay ; Performance ; Medicine ; R
Subject code	500
Language	English
Publishing date	2024-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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

Kaoru Murakami / Ian Pagano / Hideki Furuya / Timothy Daskivich / Dave Mori / Charles J. Rosser

Diagnostics, Vol 12, Iss 131, p

2022 Volume 131

Abstract: Oncuria™ is a validated quantitative multiplex immunoassay capable of detecting bladder cancer from a voided urine sample. Herein, we sought to determine whether Oncuria™ affects physicians’ use of non-invasive and invasive diagnostic tests for ... ...

Abstract	Oncuria™ is a validated quantitative multiplex immunoassay capable of detecting bladder cancer from a voided urine sample. Herein, we sought to determine whether Oncuria™ affects physicians’ use of non-invasive and invasive diagnostic tests for microhematuria, gross hematuria, and bladder cancer surveillance. We conducted a survey-based study to assess physician management of nine clinical scenarios involving real-world data from patients with gross hematuria, microhematuria, and bladder cancer on surveillance. We randomly sampled 15 practicing urologists and generated data including 135 patient-by-urologist interactions and 2160 decision points. Urologists recommended a selection of diagnostic tests and procedures before and after Oncuria™ results were provided. We assessed changes in provider use of non-invasive and invasive diagnostic tests after Oncuria™ results were provided. Over 90% of all urologists changed their diagnostic behavior in at least one patient case with the addition of Oncuria™ results. The total number of diagnostic procedures was reduced by 31% following the disclosure of a negative Oncuria™ test and 27% following the disclosure of a positive Oncuria™ test. This is pilot study has the potential to shed light on the analysis of our four large multicenter international studies deploying Oncuria TM . The Oncuria™ urine-based test, a molecular diagnostic capable of ruling out the presence of bladder cancer, reduces both unnecessary invasive and non-invasive diagnostics and has the potential to reduce costs and improve patient outcomes.
Keywords	biomarker ; clinical utility ; cytology ; cystoscopy ; hematuria ; bladder cancer ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: On the brink of extinction

Hideki Furuya / Dean Brenner / Charles J. Rosser

Journal of Translational Medicine, Vol 15, Iss 1, Pp 1-

the future of translational physician-scientists in the United States

2017 Volume 3

Abstract: Abstract Over the past decade, we have seen an unparalleled growth in our knowledge of cancer biology and the translation of this biology into a new generation of therapeutic tools that are changing cancer treatment outcomes. With the continued explosion ...

Abstract	Abstract Over the past decade, we have seen an unparalleled growth in our knowledge of cancer biology and the translation of this biology into a new generation of therapeutic tools that are changing cancer treatment outcomes. With the continued explosion of new biologic discoveries, we find ourselves with a limited number of trained and engaged translational physician-scientists capable of bridging the chasm between basic science and clinical science. Here, we discuss the current state translational physician-scientists find themselves in and offer solutions to navigate during this difficult time.
Keywords	Translational research ; Physician-scientist ; Career ; Funding ; NIH ; Medicine ; R
Language	English
Publishing date	2017-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: MRI/RNA-Seq-Based Radiogenomics and Artificial Intelligence for More Accurate Staging of Muscle-Invasive Bladder Cancer

Touseef Ahmad Qureshi / Xingyu Chen / Yibin Xie / Kaoru Murakami / Toru Sakatani / Yuki Kita / Takashi Kobayashi / Makito Miyake / Simon R. V. Knott / Debiao Li / Charles J. Rosser / Hideki Furuya

International Journal of Molecular Sciences, Vol 25, Iss 1, p

2023 Volume 88

Abstract: Accurate staging of bladder cancer assists in identifying optimal treatment (e.g., transurethral resection vs. radical cystectomy vs. bladder preservation). However, currently, about one-third of patients are over-staged and one-third are under-staged. ... ...

Abstract	Accurate staging of bladder cancer assists in identifying optimal treatment (e.g., transurethral resection vs. radical cystectomy vs. bladder preservation). However, currently, about one-third of patients are over-staged and one-third are under-staged. There is a pressing need for a more accurate staging modality to evaluate patients with bladder cancer to assist clinical decision-making. We hypothesize that MRI/RNA-seq-based radiogenomics and artificial intelligence can more accurately stage bladder cancer. A total of 40 magnetic resonance imaging (MRI) and matched formalin-fixed paraffin-embedded (FFPE) tissues were available for analysis. Twenty-eight (28) MRI and their matched FFPE tissues were available for training analysis, and 12 matched MRI and FFPE tissues were used for validation. FFPE samples were subjected to bulk RNA-seq, followed by bioinformatics analysis. In the radiomics, several hundred image-based features from bladder tumors in MRI were extracted and analyzed. Overall, the model obtained mean sensitivity, specificity, and accuracy of 94%, 88%, and 92%, respectively, in differentiating intra- vs. extra-bladder cancer. The proposed model demonstrated improvement in the three matrices by 17%, 33%, and 25% and 17%, 16%, and 17% as compared to the genetic- and radiomic-based models alone, respectively. The radiogenomics of bladder cancer provides insight into discriminative features capable of more accurately staging bladder cancer. Additional studies are underway.
Keywords	bladder cancer ; radiogenomics ; artificial intelligence ; MRI ; RNA-seq ; Biology (General) ; QH301-705.5 ; Chemistry ; QD1-999
Subject code	610 ; 616
Language	English
Publishing date	2023-12-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Influencing Factors on the Oncuria™ Urinalysis Assay

Kaoru Murakami / Ian Pagano / Runpu Chen / Yijun Sun / Steve Goodison / Charles J. Rosser / Hideki Furuya

Diagnostics, Vol 11, Iss 1023, p

An Experimental Model

2021 Volume 1023

Abstract: Background: The Oncuria™ urine test for the detection of bladder cancer measures a multiplex protein signature. In this study, we investigated the influence of urinary cellularity, protein, and hematuria on the performance of the Oncuria™ test in an ex ... ...

Abstract	Background: The Oncuria™ urine test for the detection of bladder cancer measures a multiplex protein signature. In this study, we investigated the influence of urinary cellularity, protein, and hematuria on the performance of the Oncuria™ test in an ex vivo experimental model. Materials and Methods: Pooled urine from healthy subjects was spiked with cultured benign (UROtsa) or malignant cells (T24), cellular proteins, or whole blood. The resulting samples were analyzed using the Oncuria™ test following the manufacturer’s instructions. Results: Urine samples obtained from healthy subjects were negative for bladder cancer by Oncuria™ test criteria. The majority of the manipulated conditions did not result in a false-positive test. The addition of whole blood (high concentration) did result in a false-positive result, but this was abrogated by sample centrifugation prior to analysis. The addition of cellular proteins (high concentration) resulted in a positive Oncuria™ test, and this was unaffected by pre-analysis sample centrifugation. Conclusions: The Oncuria™ multiplex test performed well in the ex vivo experimental model and shows promise for clinical application. The identification of patients who require additional clinical evaluation could reduce the need to subject patients who do not have bladder cancer to frequent, uncomfortable and expensive cystoscopic examinations, thus benefiting both patients and the healthcare system.
Keywords	biomarkers ; bladder cancer ; multiplex ; protein ; urinalysis ; Medicine (General) ; R5-920
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Association of SNPs in the PAI1 Gene with Disease Recurrence and Clinical Outcome in Bladder Cancer

Kaoru Murakami / Hideki Furuya / Kanani Hokutan / Steve Goodison / Ian Pagano / Runpu Chen / Cheng-Huang Shen / Michael W. Y. Chan / Chi Fai Ng / Takashi Kobayashi / Osamu Ogawa / Makito Miyake / Mark Thornquist / Yoshiko Shimizu / Kazukuni Hayashi / Zhangwei Wang / Herbert Yu / Charles J. Rosser

International Journal of Molecular Sciences, Vol 24, Iss 4943, p

2023 Volume 4943

Abstract: Purpose: Bladder cancer (BCa) is one of the most common cancer types worldwide and is characterized by a high rate of recurrence. In previous studies, we and others have described the functional influence of plasminogen activator inhibitor-1 (PAI1) in ... ...

Abstract	Purpose: Bladder cancer (BCa) is one of the most common cancer types worldwide and is characterized by a high rate of recurrence. In previous studies, we and others have described the functional influence of plasminogen activator inhibitor-1 (PAI1) in bladder cancer development. While polymorphisms in PAI1 have been associated with increased risk and worsened prognosis in some cancers, the mutational status of PAI1 in human bladder tumors has not been well defined. Methods: In this study, we evaluated the mutational status of PAI1 in a series of independent cohorts, comprised of a total of 660 subjects. Results: Sequencing analyses identified two clinically relevant 3′ untranslated region (UTR) single nucleotide polymorphisms (SNPs) in PAI1 (rs7242; rs1050813). Somatic SNP rs7242 was present in human BCa cohorts (overall incidence of 72%; 62% in Caucasians and 72% in Asians). In contrast, the overall incidence of germline SNP rs1050813 was 18% (39% in Caucasians and 6% in Asians). Furthermore, Caucasian patients with at least one of the described SNPs had worse recurrence-free survival and overall survival ( p = 0.03 and p = 0.03, respectively). In vitro functional studies demonstrated that SNP rs7242 increased the anti-apoptotic effect of PAI1, and SNP rs1050813 was related to a loss of contact inhibition associated with cellular proliferation when compared to wild type. Conclusion: Further investigation of the prevalence and potential downstream influence of these SNPs in bladder cancer is warranted.
Keywords	plasminogen activator inhibitor-1 ; bladder cancer ; 3′ UTR SNP ; recurrence ; survival ; apoptosis ; Biology (General) ; QH301-705.5 ; Chemistry ; QD1-999
Subject code	616
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A Diagnostic Gene Expression Signature for Bladder Cancer Can Stratify Cases into Prescribed Molecular Subtypes and Predict Outcome

Runpu Chen / Ian Pagano / Yijun Sun / Kaoru Murakami / Steve Goodison / Ramanathan Vairavan / Malak Tahsin / Peter C. Black / Charles J. Rosser / Hideki Furuya

Diagnostics, Vol 12, Iss 8, p

2022 Volume 1801

Abstract: Bladder cancer is a biologically heterogeneous disease with variable clinical presentations, outcomes and responses to therapy. Thus, the clinical utility of single biomarkers for the detection and prediction of biological behavior of bladder cancer is ... ...

Abstract	Bladder cancer is a biologically heterogeneous disease with variable clinical presentations, outcomes and responses to therapy. Thus, the clinical utility of single biomarkers for the detection and prediction of biological behavior of bladder cancer is limited. We have previously identified and validated a bladder cancer diagnostic signature composed of 10 biomarkers, which has been incorporated into a multiplex immunoassay bladder cancer test, Oncuria™. In this study, we evaluate whether these 10 biomarkers can assist in the prediction of bladder cancer clinical outcomes. Tumor gene expression and patient survival data from bladder cancer cases from The Cancer Genome Atlas (TCGA) were analyzed. Alignment between the mRNA expression of 10 biomarkers and the TCGA 2017 subtype classification was assessed. Kaplan–Meier analysis of multiple gene expression datasets indicated that high expression of the combined 10 biomarkers correlated with a significant reduction in overall survival. The analysis of three independent, publicly available gene expression datasets confirmed that multiplex prognostic models outperformed single biomarkers. In total, 8 of the 10 biomarkers from the Oncuria™ test were significantly associated with either luminal or basal molecular subtypes, and thus, the test has the potential to assist in the prediction of clinical outcome.
Keywords	bladder cancer ; biomarker ; molecular diagnostic ; outcomes ; multiplex ; Medicine (General) ; R5-920
Subject code	616 ; 610
Language	English
Publishing date	2022-07-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Analytical validation of ONCURIA™ a multiplex bead-based immunoassay for the non-invasive bladder cancer detection

Hideki Furuya / Lindlelyn Tabula / Riko Lee / Paul Kralovec / Martin Ramsden / Regan Wong / Charles J. Rosser

Practical Laboratory Medicine, Vol 22, Iss , Pp e00189- (2020)

2020

Abstract: Background: The 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. Method: ology: Using Luminex xMAP ... ...

Abstract	Background: The 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. Method: ology: 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. Results: Analytical 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. Conclusion: To 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.
Keywords	Medicine (General) ; R5-920 ; Chemistry ; QD1-999
Subject code	616
Language	English
Publishing date	2020-11-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Multiplex Urinary Tests for Bladder Cancer Diagnosis

Virginia Urquidi / Charles J. Rosser / Steve Goodison

European Medical Journal Urology, Vol 1, Iss 1, Pp 70-

2013 Volume 73

Abstract: The development of accurate and reliable molecular assays that could diagnose bladder cancer would be of significant benefit to both patients and the healthcare system. Non-invasive assays that have utility not only for diagnosis, but also for monitoring ...

Abstract	The development of accurate and reliable molecular assays that could diagnose bladder cancer would be of significant benefit to both patients and the healthcare system. Non-invasive assays that have utility not only for diagnosis, but also for monitoring disease recurrence and response to treatment, are needed. Current urinary tests lack sufficient sensitivity or specificity, often because of a reliance on single biomarkers, but high-throughput technologies are enabling the derivation of more accurate panels of biomarkers. In this article, we review some of the promising investigational studies that are revealing multiplex biomarker signatures that may augment current bladder cancer detection strategies.
Keywords	Biomarkers ; Bladder Cancer ; Diagnosis ; Non-Invasive ; Urinalysis ; Medicine ; R
Language	English
Publishing date	2013-12-01T00:00:00Z
Publisher	European Medical Journal
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer

Yosuke Hirasawa / Ian Pagano / Runpu Chen / Yijun Sun / Yunfeng Dai / Amit Gupta / Sergei Tikhonenkov / Steve Goodison / Charles J. Rosser / Hideki Furuya

Journal of Translational Medicine, Vol 19, Iss 1, Pp 1-

2021 Volume 10

Abstract: 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 ... ...

Abstract	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.
Keywords	Biomarkers ; Bladder cancer ; Multiplex ; Protein ; Urinalysis ; Medicine ; R
Subject code	616
Language	English
Publishing date	2021-04-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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