Clinical performance of Bladder EpiCheck™ versus voided urine cytology for detecting recurrence of nonmuscle invasive bladder cancer: Systematic review and meta-analysis

Background: Nonmuscle invasive bladder cancer (NMIBC) has a favorable prognosis but has high propensity for recurrence. Recent development in one of the urinary biomarker tests, Bladder EpiCheck™, offers a noninvasive and accurate method to detect NMIBC recurrence. In this study, we aimed to compare the diagnostic performance of Bladder EpiCheck™ with urine cytology to detect NMIBC recurrence.

Methods: We performed a systematic review search through PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus from inception to July 2023. Diagnostic accuracy was defined by sensitivity, negative predictive value (NPV), specificity, and positive predictive value (PPV).

Results: A total of 6 studies involving 1588 patients were included. Bladder EpiCheck™ has a sensitivity and specificity of 0.81 (95% CI: 0.63-0.91; I²: 43%) and 0.87 (95% CI: 0.83-0.91; I²: 20%), respectively. On the other hand, urine cytology has a sensitivity and specificity of 0.63 (95% CI: 0.29-0.87; I²: 61%) and 0.97 (95% CI: 0.78-1.00; I²: 79%), respectively. EpiCheck™ has a higher NPV (0.94 (95% CI: 0.87-0.97) vs. 0.84 (95% CI: 0.80-0.87) though a lower PPV (0.62 (95% CI: 0.45-0.76) vs. 0.87 (95% CI: 0.56-0.97) than urine cytology. In our subgroup analysis, the sensitivity of Bladder EpiCheck™ for detecting high-grade tumors improved to 0.90 (95% CI: 0.83-0.94) while that for urine cytology improved to 0.72 (95% CI: 0.50-0.87).

Conclusion: Bladder EpiCheck™ has a high sensitivity and NPV for detecting recurrence among patients with NMIBC.