TEST:

Xpert® Bladder Cancer Monitor

Grade-adapted interpretation is warranted. Prospective validation with standardised grade-specific reporting is needed.

The Xpert® Bladder Cancer Monitor test is a reliable and sensitive tool for monitoring patients with NMIBC. It performs better than urine cytology with higher sensitivity, and it appears to be more effective in detecting low- and high-grade NMIBC.

Furthermore, FISH showed superi-or sensitivity and similar or lower specificity in comparison to cytology, in the over-whelming majority of studies, while Xpert®BC Detection showed the highest sensitivity values among all evaluated assays, reaching 100% even in the low-grade subgroup, albeit at the cost of a significantly reduced specificity. Despite the adequate overall sensitivity and specificity of FISH, its suboptimal performance in the detection of low-grade UTUC seems to preclude its use as a stand-alone screening test.

P=N/A, N=127, Completed, Jørgen Bjerggaard Jensen | Enrolling by invitation --> Completed | Trial primary completion date: Jul 2024 --> Dec 2025

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

XBCD identified five true positives and 166 true negatives, yielding a sensitivity of 71.4%, specificity of 88.8%, and a negative predictive value of 98.8%. In this low-prevalence setting, XBCD demonstrated potential as a triage tool to reduce the number of procedures and support earlier BC detection, although findings are limited by the small number of cancer cases.

P=N/A, N=1475, Not yet recruiting, Christian Bolenz

The integrated approach of IHC with genotyping could improve risk stratification and guide personalized management strategies. Moreover, as cytology is less sensitive to diagnose UC, especially low-grade tumours, Xpert BCM can be used as a promising diagnostic test for both primary and recurrent BC settings.

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