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

Alternative, noninvasive, cost-effective methods to complement or serve as substitutes to current standard-of-care (SOC) procedures in nonmuscle-invasive bladder cancer (NMIBC) follow-up are needed. Uromonitor is a urine biomarker test detecting bladder cancer recurrence through the screening of TERT, FGFR3, and KRAS hotspot mutations. The aim of this study was to assess Uromonitor performance by comparing it with the current SOC methods. Four hundred thirty-nine patients with 528 NMIBC surveillances were enrolled in this study. All patients 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 with the gold standard cystoscopy plus transurethral resection of bladder tumor histopathology. Uromonitor displayed a sensitivity of 87% (95% CI, 74-95), with only 6 of 47 recurrences failing to be detected; specificity of 99% (98-100); PPV of 93% (82-98); and an NPV of 99% (97-99). Cystoscopy showed a total of 22 false positives (32%) not confirmed by transurethral resection of bladder tumor, whereas Uromonitor presented only 3 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. 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.