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

Abstract

ABSTRACTIntroductionBladder cancer (BC) remains the most common malignancy of the urinary tract, with non-muscle invasive BC (NMIBC) representing the vast majority of bladder cancer patients. The current standard of care (SOC) follow-up in NMIBC patients demands an intensive schedule and requires costly and burdensome methods, driving the development of alternative, non-invasive, cost-effective methods that may complement or serve as substitutes to cystoscopy and cytology. Uromonitor® is a urine biomarker test that detects hotspot mutations in three genes (TERT, FGFR3, andKRAS) for the evaluation of disease recurrence. The aim of the current study was to assess its performance comparing it to the current SOC methods.Materials and MethodsA total of 528 NMIBC surveillances from 439 individual patients were enrolled from December 2021 to June 2023. All subjects underwent SOC methods and provided an urine sample before undergoing cystoscopy for Uromonitor® analysis. 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) pathology.ResultsUromonitor® displayed a sensitivity of 87.2%, with only 6 recurrences failing to be detected by the urinary biomarker test, a specificity of 99.2%, a positive predictive value (PPV) of 93.2% and a negative predictive value (NPV) of 98.8%. Cystoscopy showed a total of 22 (31,88%) false positives not confirmed by TURBT, while Uromonitor® presented only 3 positive tests where no suspected lesions were found in cystoscopy. Sensitivity, specificity and NPV values for Uromonitor® also remained high across all NMIBC grades and stages.ConclusionIn the present study, we confirmed that the Uromonitor® biomarker test represents a reliable tool in the detection of NMIBC recurrence in patients undergoing routine surveillance, regardless of stage and grade. It offers either an alternative or a complement to the current SOC methods, providing rapid results and a non-invasive option, potentially improving patients’ quality of life and helping reduce the economic burden of NMIBC follow-up. To our knowledge, this is the largest single-center study assessing Uromonitor®’s performance and thus validating its usefulness in clinical practice.