Evidence

How accurate is GALEAS Bladder?

Results from NHS patients and the manufacturer's validation, with the limits explained.

Laboratory scientists working with samples, pipettes and a microscope
92%of bladder cancers detected (71 of 77)
17/17muscle-invasive cancers detected
99.3%chance of no cancer after a negative result
UKCAmarked diagnostic test, made in the UK

Source: real-world study of 964 patients referred urgently with blood in the urine across seven NHS urology departments (European Urology Oncology, 2026). Figures apply to that group of patients. See the full evidence.

Real-world NHS data

964 patients in seven NHS urology departments

People referred urgently with blood in the urine gave a urine sample before their planned cystoscopy. Results were compared with cystoscopy and confirmed pathology.

MeasureResult
Bladder cancers in the group77 of 964 (8.0%)
Cancers detected by GALEAS Bladder71 of 77 (92.2%)
Muscle-invasive cancers detected17 of 17
High-grade cancers detected35 of 36
Chance of no cancer after a negative result99.3%

The authors note a limitation: some people tested positive without a tumour visible on cystoscopy, and their later diagnoses were not available.

Manufacturer validation

Detection by stage and grade

710 urine samples from three UK clinical cohorts. Specificity was 86% in every category.

Detection is lowest for grade 1 tumours, which grow slowly and are the least likely to spread. NMIBC: non-muscle-invasive. MIBC: muscle-invasive.

Background

How the test was developed

GALEAS Bladder was developed by Nonacus with Professor Rik Bryan and Dr Doug Ward at the University of Birmingham, and launched at the European Association of Urology meeting in 2023.

It is UKCA marked under the UK Medical Devices Regulations for triage of people with haematuria. NHS commissioners have since procured at-home GALEAS kits for haematuria pathways, with wider adoption planned across the West Midlands.

Uses such as monitoring after treatment are being researched but are not yet established.

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