Real-World Multicentre Evaluation of GALEAS Bladder for Detecting Bladder Cancer in UK NHS Haematuria Clinics

BACKGROUND AND OBJECTIVE: Cystoscopy is a core component of haematuria investigations; however, it is invasive and resource intensive. GALEAS Bladder is a DNA-based diagnostic urine test that measures mutations in 23 bladder cancer (BC)-associated genes. OBJECTIVE: We aimed to assess the diagnostic performance of GALEAS Bladder in real-world patients with haematuria and its utility as a molecular triage tool in this setting. METHODS: Patients referred for urgent investigation of haematuria were prospectively enrolled across seven UK National Health Service urology departments between October 2024 and June 2025. Urine samples were collected prior to cystoscopy and analysed by GALEAS Bladder. Assay results were compared with cystoscopy and biopsy/transurethral resection of bladder tumour findings. KEY FINDINGS AND LIMITATIONS: Cystoscopic findings and GALEAS Bladder results were available for 964 participants (575 visible and 294 non-visible haematuria, 95 unknown), including 77 (8.0%) newly diagnosed with pathology-confirmed BC. The assay detected 71 of the 77 BCs, including all 17 muscle-invasive BCs and 35 of the 36 high-grade BCs, with negative predictive value >99% (95% confidence interval [CI] 98-100), positive predictive value 50% (95% CI 42-58), positive likelihood ratio (LR) 11.5, and negative LR 0.09. Decision curve analysis showed net benefit over cystoscopy for all referrals. Limitations include observational study design over a limited timeframe and absence of subsequent diagnoses for participants with positive GALEAS Bladder test results without cystoscopically visible tumour. CONCLUSIONS AND CLINICAL IMPLICATIONS: GALEAS Bladder is a clinically implementable molecular urine test that detects new cases of BC with high negative predictive value and favourable LRs in patients undergoing urgent investigation of haematuria. These data show that GALEAS Bladder can be used now to triage patients with haematuria to immediate or deferred cystoscopy.