TEST:

Uromonitor®

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.

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.