Diagnostic Test Accuracy of Commercially Available Tests for The Recurrence of Bladder Cancer: A Systematic Review and Meta-Analysis

ABSTRACT Objective Bladder cancer (BC) is the most common malignancy of the urinary system and among the most frequently diagnosed cancers worldwide. This systematic review and meta-analysis aimed to evaluate the diagnostic accuracy of commercially available urinary biomarkers tests (UBTs) for detecting BC recurrence, focusing on pooled sensitivity and specificity estimates across different tests. Methods A systematic search was performed on PubMed and EMBASE up to May 2025 to identify studies assessing recurrence of BC in previously diagnosed patients using non-FDA approved UBTs, including Xpert Bladder Cancer, Bladder Epicheck, ADXbladder and Uromonitor. Eligible studies were synthesized using the bivariate Generalized Linear Mixed Model (GLMM) model. Results Out of 307 initially screened citations, 33 studies met the eligibility criteria, encompassing a total of 10,478 patients. Xpert Bladder Cancer was evaluated on 13 studies and Bladder Epicheck was assessed on 10 studies. ADXbladder and Uromonitor were assessed in four and six studies, respectively. Meta-analyses included 13 studies for Xpert Bladder Cancer and 10 studies for Bladder Epicheck, yielding pooled sensitivity (95% CI) and specificity (95% CI) estimates of 0.71 (0.61-0.79) and 0.78 (0.74-0.82) for Xpert Bladder Cancer, and 0.75 (0.61-0.86) and 0.90 (0.84-0.94) for Bladder Epicheck. For ADXbladder and Uromonitor, meta-analyses incorporated four and six studies, respectively, resulting in pooled sensitivity and specificity values of 0.55 (0.40-0.69) and 0.60 (0.44-0.75) for ADXbladder, and 0.77 (0.61-0.88) and 0.96 (0.91-0.98) for Uromonitor. Conclusions This meta-analysis reveals that commercially UBTs for BC recurrence have varying diagnostic accuracy. Among the evaluated tests, Uromonitor demonstrated the highest pooled sensitivity and specificity, while Xpert Bladder Cancer and Bladder Epicheck showed reliable diagnostic performance. Further research is needed particularly for less extensively studied assays to establish their diagnostic performance.