ABSTRACT BACKGROUND Non-invasive urine-based biomarkers can potentially improve current diagnostic and monitoring protocols for bladder cancer (BC). Here we assess the performance of earlier

published biomarker panels for BC detection (BC-116) and monitoring of recurrence (BC-106) in combination with cytology, in two prospectively collected patient cohorts. METHODS Of the 602

patients screened for BC, 551 were found eligible. For the primary setting, 73 patients diagnosed with primary BC (_n_ = 27) and benign urological disorders, including patients with

macroscopic haematuria, cystitis and/or nephrolithiasis (_n_ = 46) were included. In total, 478 patients under surveillance were additionally considered (83 BC recurrences; 395 negative for

significantly better performance (_P_ = 0.5672). A diagnostic score including BC-106 and cytology was evaluated (AUCNom106 = 0.82), significantly outperforming both cytology (AUCcyt = 0.72;

_P_ = 0.0022) and BC-106 (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 showing

>95% negative predictive value, might be useful for decreasing the number of cystoscopies during surveillance. Access through your institution Buy or subscribe This is a preview of

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ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support SIMILAR CONTENT BEING VIEWED BY OTHERS URINE BIOMARKERS IN BLADDER

CANCER — CURRENT STATUS AND FUTURE PERSPECTIVES Article 24 May 2023 NOVEL URINARY PROTEIN BIOMARKER PANEL FOR EARLY DIAGNOSIS OF GASTRIC CANCER Article Open access 16 September 2020

UNTARGETED URINARY METABOLOMICS FOR BLADDER CANCER BIOMARKER SCREENING WITH ULTRAHIGH-RESOLUTION MASS SPECTROMETRY Article Open access 16 June 2023 DATA AVAILABILITY All data (except raw

files) generated or analysed during this study are included in this article (and its supplementary information files). Raw data are available upon request from the corresponding author.

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H2020-MSCA-IF-2016) a programme funded by the European Commission (EC) under Marie Sklodowska-Curie actions (MSCA) H2020 Work Programme. The specific role of the funding organisation (EC)

was to financially support the acquisition of the data and part of the data analysis. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Laboratory and Department of Urology, Hospital Clinic de

Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain Lourdes Mengual, Mercedes Ingelmo-Torres & Antonio Alcaraz * Department of Biomedical

Sciences, Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain Lourdes Mengual * Department of Biomarker Research, Mosaiques Diagnostics, Hannover, Germany

Maria Frantzi, Marika Mokou & Harald Mischak * Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands Michiel Vlaming & Antoine G. Van der Heijden *

University Hospital Schleswig-Holstein, Campus Lübeck, Department of Urology, Lübeck, Germany Axel S. Merseburger & Marie C. Roesch * Experimental Urology, Department of Urology, Medical

University of Innsbruck, Innsbruck, Austria Zoran Culig * Systems Biology Center, Biomedical Research Foundation, Academy of Athens, Athens, Greece Antonia Vlahou * Institute of

Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK Harald Mischak Authors * Lourdes Mengual View author publications You can also search for this author inPubMed Google

Scholar * Maria Frantzi View author publications You can also search for this author inPubMed Google Scholar * Marika Mokou View author publications You can also search for this author

inPubMed Google Scholar * Mercedes Ingelmo-Torres View author publications You can also search for this author inPubMed Google Scholar * Michiel Vlaming View author publications You can also

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publications You can also search for this author inPubMed Google Scholar * Zoran Culig View author publications You can also search for this author inPubMed Google Scholar * Antonio Alcaraz

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Harald Mischak View author publications You can also search for this author inPubMed Google Scholar * Antoine G. Van der Heijden View author publications You can also search for this author

inPubMed Google Scholar CONTRIBUTIONS AGVdH had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study

concept and design: LM, MF, AV, HM and AGVdH; acquisition of the data: LM, MF, MI-T and MV; analysis and interpretation of the data: LM, MF, MM, MI-T, MV; drafting of the manuscript: LM, MF,

MM; critical revision of the manuscript for important intellectual content: LM, MF, MM, MI-T, MV, ASM, MCR, ZC, AA, AV, HM and AGVdH; statistical analysis: LM, MF and MM; obtaining funding:

MF; administrative, technical or material support: LM, AA, AV, HM and AGVdH; supervision: LM, ASM, MCR, ZC, AA, HM and AGVdH; other/software validation: MF and MM. CORRESPONDING AUTHOR

Correspondence to Maria Frantzi. ETHICS DECLARATIONS COMPETING INTERESTS Prof. HM holds ownership interest in Mosaiques Diagnostics GmbH. Dr. MF and Dr. MM are employed by Mosaiques

Diagnostics GmbH. The remaining authors declare no competing interests. ETHICS APPROVAL AND CONSENT TO PARTICIPATE Informed consent forms were obtained and adhered to Institutional Review

Board-approved guidelines. Ethical approval for this study was obtained by the Ethics Committee in Medical School of Hannover (ID:3274–2016). The study was performed in accordance with the

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agreement and applicable law. Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Mengual, L., Frantzi, M., Mokou, M. _et al._ Multicentric validation of diagnostic tests based on

BC-116 and BC-106 urine peptide biomarkers for bladder cancer in two prospective cohorts of patients. _Br J Cancer_ 127, 2043–2051 (2022). https://doi.org/10.1038/s41416-022-01992-3 Download

citation * Received: 23 May 2022 * Revised: 13 September 2022 * Accepted: 14 September 2022 * Published: 03 October 2022 * Issue Date: 23 November 2022 * DOI:

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