TEST:

Bladder EpiCheck®

During initial diagnosis of BC, BE showed higher SN with similar SP compared with urine cytology. Diagnostic performance of BE increased gradually across EAU prognostic NMIBC factor risk classification, outperforming cytology in all risk groups. Moreover, EpiScore values are able to identify high risk BC patients, ≥T1 tumours and HG tumours.

The high negative predictive value suggests that Bladder EpiCheck® may help identify patients without residual tumor and potentially avoid unnecessary Re-TURB. Larger prospective multicenter studies are required to confirm these findings.

P=N/A, N=1000, Recruiting, Nucleix Ltd.

P2, N=240, Recruiting, White River Junction Veterans Affairs Medical Center | Phase classification: P=N/A --> P2

P=N/A, N=800, Recruiting, Nucleix Ltd. | N=600 --> 800 | Trial completion date: Apr 2026 --> Dec 2026 | Trial primary completion date: Feb 2026 --> Aug 2026

P=N/A, N=600, Recruiting, Nucleix Ltd. | Not yet recruiting --> Recruiting

P2, N=262, Not yet recruiting, Chiti Arturo

BE addition to WLC, with PDD-guided biopsy performed for BE-positive cases, reveals the true performance of BE and WLC and significantly improves the detection of HG disease, allowing earlier intervention with potentially bladder-sparing options.

This review explores the current state of UTUC diagnosis, compares BE with conventional and emerging biomarkers, and discusses its clinical applications, limitations, and future perspectives. The integration of molecular biomarkers like BE into clinical practice has the potential to revolutionize UTUC diagnosis, improving patient outcomes through more precise, non-invasive detection strategies.

UroFollow is the first urine marker-based randomized trial in low/intermediate-risk NMIBC patients. We conclude that 6-monthly marker-based follow-up after negative 3-mo WLC is safe in this cohort. Results of contemporary urine markers suggest that their potential for use in marker-based surveillance, however, requires prospective confirmation.