Uromonitor®: Clinical Validation and Performance Assessment of a Urinary Biomarker within the Surveillance of Non-Muscle Invasive Bladder Cancer Patients.

Purpose: Alternative, non-invasive, cost-effective methods to complement or serve as substitutes to current standard of care (SOC) procedures in non-muscle invasive bladder cancer (NMIBC) follow-up, are needed. Uromonitor® is a urine biomarker test detecting bladder cancer (BC) recurrence through the screening of TERT, FGFR3 and KRAS hotspot mutations. The aim of the current study is to assess Uromonitor® performance comparing it to the current SOC methods.

Materials and methods: 528 NMIBC surveillances from 439 patients were enrolled in the study. All subjects underwent SOC methods and provided a urine sample for Uromonitor® analysis before undergoing cystoscopy. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for recurrence and compared to the gold-standard cystoscopy plus trans-urethral resection (TURBT) histopathology.

Results: Uromonitor® displayed a sensitivity of 87% (74-95, 95% CI), with only 6 out of 47 recurrences failing to be detected, a specificity of 99% (98-100) PPV of 93% (82-98) and a NPV of 99% (97-99). Cystoscopy showed a total of 22 (32%) false positives not confirmed by TURBT, while Uromonitor® presented only three positive tests where no lesions were found. Overall recurrence rate was 8.9% (n=47) among 528 total screenings. Sensitivity, specificity, PPV and NPV values for Uromonitor® remained high across all NMIBC grades and stages.

Conclusions: 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.