A prospective, multicentre real‑world evaluation of GALEAS™ Bladder in UK NHS haematuria clinics detected 71 of 77 bladder cancers identified in the study cohort, giving a sensitivity of 92.2% and overall reported sensitivity and specificity of about 92%, with a negative predictive value greater than 99%.

The study enrolled 964 patients referred for urgent haematuria between October 2024 and June 2025 at seven NHS urology departments. Seventy‑seven of those patients were ultimately diagnosed with bladder cancer; GALEAS™ Bladder returned positive results for 71 of these cases.

In the cohort, GALEAS™ Bladder detected all muscle‑invasive cancers identified in the study (17 of 17) and detected 35 of 36 high‑grade cancers, according to the study authors.

GALEAS™ Bladder is a commercial urine‑based molecular assay produced by Nonacus. The test uses targeted ultra‑deep next‑generation sequencing across a gene panel of approximately 23 genes to identify tumour‑derived DNA in urine samples. Reported sample‑to‑report turnaround time is about 5–10 working days.

Several NHS organisations in England have evaluated or introduced GALEAS™ Bladder into local pathways or service evaluation programmes. Examples cited by reporting and NHS organisations include University Hospitals Coventry & Warwickshire and other West Midlands trusts, George Eliot Hospital, and a Leicester trust.

The study was funded by Nonacus Limited. The authors and reporting outlets state that the full manuscript is published in European Urology Oncology (DOI 10.1016/j.euo.2026.08.005; publication dated 2 September 2026). Reporting and the preprint version of the study note limitations of the observational/service‑evaluation design, a limited timeframe and cohort composition, and they flag the need for further evaluation — for example, the absence of later diagnoses for some participants with positive GALEAS results but no cystoscopically visible tumour.

The multicentre real‑world data indicate high sensitivity and specificity for a urine‑based DNA assay in people referred for haematuria, and several NHS bodies are piloting the test. The study authors and reporting outlets emphasise the need for further assessment to define the test’s role across clinical pathways and over longer follow‑up.