TEST:

Uromonitor®

The sensitivity estimate showed very low certainty due to pronounced heterogeneity, underscoring the need for careful interpretation. With advancing DNA recovery methods, incorporation of droplet digital PCR, and rigorous evaluations in prospective multicenter studies, Uromonitor® may become an integral element of risk-adapted follow-up strategies.

P=N/A, N=16, Recruiting, VA Office of Research and Development | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026

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.