What is it about?

This study conducts an external multicentre validation of Uromonitor version 2 (v2) as a biomarker for detecting non-muscle-invasive bladder cancer (NMIBC) recurrence in a real-world-evidence setting. It aims to compare the effectiveness of Uromonitor-v2 with traditional cytology. The research highlights the high recurrence rate of NMIBC and the need for improved follow-up strategies due to the limitations of cystoscopy and cytology. Uromonitor-v2, a urine-based test that detects specific genetic alterations using real-time quantitative PCR, is evaluated for its sensitivity, specificity, and overall accuracy. Previous studies of Uromonitor-v1 showed high sensitivity and specificity, although there were some false positives. The introduction of Uromonitor-v2 refines the molecular approach by focusing on common genetic mutations in NMIBC, with recent studies suggesting mixed results regarding its clinical applicability. This research contributes to assessing the evolution and potential clinical implementation of Uromonitor-v2 as a reliable tool for NMIBC management.

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Why is it important?

This study investigates the potential of Uromonitor-v2 as a biomarker for detecting non-muscle-invasive bladder cancer (NMIBC) recurrence in a real-world-evidence setting across multiple centers. The research is significant as it addresses the high recurrence rate of NMIBC and the challenges associated with current follow-up methods, such as cystoscopy and cytology, which are either invasive or lack sensitivity. This study aims to validate a less invasive and potentially more accurate method for monitoring NMIBC, which could lead to improved patient management and reduced healthcare costs. Key Takeaways: 1. The study evaluates the performance of Uromonitor-v2, a urine-based test that detects genetic alterations in TERT, FGFR3, and KRAS genes, in a larger cohort across several centers. This approach aims to enhance the accuracy and applicability of NMIBC follow-up in clinical practice. 2. Findings reveal that while Uromonitor-v2 has demonstrated high specificity and a reasonable positive predictive value (PPV) in detecting NMIBC recurrence, its sensitivity remains a challenge, indicating the need for further refinement to improve its diagnostic potential. 3. By comparing Uromonitor-v2 with its predecessor, Uromonitor-v1, this study highlights the evolution of biomarker tests for NMIBC and underscores the importance of ongoing validation to achieve an ideal balance of sensitivity, specificity, and cost-effectiveness for routine clinical use.

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This page is a summary of: External validation of the Uromonitor®‐version 2 urine test as a biomarker for optimisation of non‐muscle‐invasive bladder cancer management, BJU International, October 2025, Wiley,
DOI: 10.1111/bju.70010.
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