TEST:

Uromonitor®

The strong specificity and NPV observed across all studies suggest a role of Uromonitor-v2 as a potential tool for NMIBC follow-up, particularly in ruling out recurrence and clarifying doubtful cystoscopy results. However, the unexpectedly low sensitivity reported in this external multicentre validation suggests the need for further investigation before routine clinical implementation.

Specificity did not significantly differ. The uTERTpm ddPCR test exhibited superior diagnostic performance over urine cytology and Uromonitor, highlighting its potential for non-invasive primary bladder cancer diagnosis.

P=N/A, N=16, Recruiting, VA Office of Research and Development | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025

During follow-up sensitivities and specificities of most urinary markers are higher compared to cytology for the detection of recurrent bladder cancer. BTA stat®, UBC® Rapid Test, and uromonitor® appear useful in this setting.

Uromonitor® represents a reliable tool in the detection of NMIBC recurrence in patients undergoing routine surveillance, regardless of stage and grade. To our knowledge, this is the largest single-center study assessing Uromonitor®´s performance, thus validating its usefulness in clinical practice.

The MODAPLEX FGFR panel allows the stratification of bladder cancer patients by determination of the FGFR3 mutational and FGFR2/3 fusion status. The PCR-based FGFR assessment by MODAPLEX FGFR panel and therascreen FGFR kit is highly concordant (78/79). The MODAPLEX assays enable fast, local FGFR assessment in a multiplexed one-step approach within few hours.

Despite its innovative approach, Uromonitor fell short of confirming the superior results anticipated from previous studies in this real-world setting. The search for an optimal urine-based biomarker for detecting and monitoring UCB remains ongoing. Results from this study highlight the complexity of developing non-invasive diagnostic tools and emphasise the importance of continued research efforts to refine these technologies.

P=N/A; Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> May 2024

In the present trial, we confirmed that the Uromonitor® biomarker test represents a reliable tool in the detection of NMIBC recurrence in patients undergoing routine surveillance, regardless of stage and grade. It offers either an alternative or a complement to the current SOC methods, providing rapid results and a non-invasive option, potentially improving patients' quality of life and helping reduce the economic burden of NMIBC follow-up. To our knowledge, this is the largest single-center study assessing Uromonitor®´s performance and thus validating its usefulness in clinical practice.

The determination of Mxi-2 and Vim3 in urine enables rapid and cost-effective differentiation between NMIBC and MIBC with a high diagnostic accuracy for tailored surgical and therapeutic evaluation. Prospective validation of urine-based prediction of muscle invasiveness is ongoing in the prospective, multicenter Bladder BRIDGister study. In addition, biomarker results are being compared with multiparametric MRI to provide an integrated, non-invasive platform for robust MIBC classification prior to surgery.

In a cohort of 1000 patients with a bladder-cancer prevalence of ~15%, this UBDT would avert 825 unnecessary cystoscopies (true-negatives) while missing 30 bladder-cancer cases (false-negatives). Due to currently limited aggregated data from only four studies with heterogeneous quality, confirmatory studies are needed.