GALEAS™ Bladder Demonstrates High Sensitivity and Specificity for Detecting Bladder Cancer: Real-World Multicentre Data from UK NHS Haematuria Clinics

ABSTRACT Background Cystoscopy is a core component of haematuria investigations but is invasive and resource-intensive. GALEAS™ Bladder is a DNA-based diagnostic urine test that measures alterations in 23 bladder cancer-associated genes. Objective To assess the diagnostic performance and clinical utility of GALEAS™ Bladder as a molecular triage tool in real-world haematuria investigation pathways. Methods Patients referred for urgent investigation of haematuria were prospectively enrolled across seven UK NHS Urology Departments between October 2024 and June 2025. Urine samples were collected prior to cystoscopy and analysed using the GALEAS™ Bladder assay (Nonacus Clinical Services, UK). Assay results were compared with cystoscopy findings. Key Findings and Limitations Cystoscopic findings and GALEAS™ Bladder results were available for 964 participants, including 77 (8.0%) newly-diagnosed with pathology-confirmed BC. The assay demonstrated an overall sensitivity of 92.2% (95% CI: 84.0-96.4%), specificity of 92.0% (95% CI: 90.0-93.6%), and negative predictive value (NPV) of 99.3% (95% CI: 98.4-99.7%) for the diagnosis of BC. For the diagnosis of high-grade BCs, sensitivity was 97.2% (95% CI: 85.8-99.5%) with an NPV of 99.9% (95% CI:99.3-100.0%). Limitations include an absence of subsequent diagnoses for participants with positive GALEAS™ Bladder test results in the absence of cystoscopically-visible tumour. Conclusions and Clinical Implications GALEAS™ Bladder is a clinically implementable molecular urine test with very high sensitivity and specificity for the diagnosis of new cases of BC in patients undergoing urgent investigation of haematuria, especially for high-grade BCs. Clinical adoption could permit the molecular triage of haematuria patients to immediate or deferred cystoscopy.