Study Need and Importance: The correct risk categorization and staging of upper tract urothelial cancer (UTUC) is key for disease management. Computerized tomography urography and urinary cytology have limited accuracy for risk stratification of UTUC. Ureteroscopy (URS) may increase the risk of bladder cancer recurrence. Recently, Bladder EpiCheck TM (EpiCheck) showed a high accuracy in the detection of bladder cancer. The aim of the study is to investigate the diagnostic accuracy of EpiCheck in the clinical management of UTUC and to compare it with urinary cytology. What We Found: EpiCheck resulted diagnostic in 83/86 (97%) and 73/75 (97%) of upper urinary tract and bladder samples, respectively. Histology was positive in 47/83 (57%) and 42/73 (58%) cases, respectively. In upper urinary tract samples, Epi-Check yielded a sensitivity/specificity/negative predictive value (NPV)/positive predictive value of 83%/ 79%/77%/84% vs 59%/88%/61%/87% of cytology. The sensitivity/NPV for high-grade tumors was 96%/97% for EpiCheck vs 71%/86% for cytology. EpiCheck indicated URS in 45/80 (56%) patients, missing 17%/4% of all/high-grade UTUC with 9% of unnecessary URS. In bladder samples, the sensitivity/NPV for high-grade tumors was 71%/ 88% for EpiCheck and 59%/87% for cytology. Limitations: As no previous studies analyzed biomarker performances in UTUC, we included a heterogeneous population of patients. The diagnostic accuracy of EpiCheck might vary in first observation vs followup setting. Furthermore, no cost-effectiveness analysis was performed. Interpretation for Patient Care: Epicheck may be an important tool to decrease the number of unnecessary URSs. The clinical implementation of Epi-Check in UTUC warrants further investigation in multicentric prospective randomized trials.
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