TEST:

Uromonitor®

In a real-world clinical setting, Uromonitor® demonstrated high specificity but limited sensitivity for detection of bladder cancer, particularly during surveillance. A negative result does not reliably exclude recurrence. Assay sensitivity thresholds and restricted variant coverage appear to be key contributors to false-negative results. These findings highlight the need for cautious clinical integration of Uromonitor®. It is unclear whether this approach has sufficient sensitivity in surveillance to safely reduce cystoscopy frequency. This underscores the need for further refinement of urine-based molecular assays, including a need for enhanced sensitivity and broader mutational coverage before routine clinical adoption.

dUM provides robust, reproducible prognostic information and significantly improves molecular risk stratification in NMIBC. These findings support its potential integration into risk-adapted surveillance strategies, pending validation in larger populations.

These findings support dPCR as a robust non-invasive diagnostic adjunct under conservative analytical conditions and justify further large-scale prospective multicentre validation in clinically representative populations undergoing bladder cancer surveillance to define its role in risk=adapted evidence-based diagnostic pathways and inform future implementation studies in clinical practice.

The dUM significantly outperformed its qPCR predecessor and cytology in sensitivity for detecting NMIBC recurrence in a real-world setting, without compromising specificity. Its high NPV supports its potential for reducing unnecessary cystoscopies. Furthermore, its combination with cystoscopy drastically increased the PPV, suggesting a role as an adjunctive tool to improve diagnostic confidence and potentially reduce unnecessary transurethral resections of bladder tumour, pending favourable cost-effectiveness.

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.