GALEAS® Bladder — Home Bladder Cancer Test

Main product description

A non-invasive urine test with performance comparable to cystoscopy

GALEAS® Bladder is an advanced DNA urine test that detects the molecular markers associated with bladder cancer. Tumour cells shed DNA into the urine; the test extracts that DNA and uses next-generation sequencing (NGS) to look for the specific genetic changes found in bladder tumours — including non-visible (microscopic) changes that a visual inspection or basic dipstick test would miss.

In real-world data from UK NHS haematuria clinics, GALEAS Bladder demonstrated:

• 92.2% sensitivity — its ability to correctly identify those with bladder cancer
• 92% specificity — its ability to correctly identify those without it
• 99.3% negative predictive value — when the result is negative, cancer is very unlikely to be present

For comparison, flexible cystoscopy in the same evaluation performed at 85% sensitivity, 87% specificity and 96% negative predictive value. In other words, GALEAS Bladder delivers results comparable to the current gold-standard procedure — from a sample you provide at home.

Reliable across all stages and grades

The test maintained high sensitivity across the full range of bladder cancer, including 100% for muscle-invasive (T2+) disease and 97% for high-grade tumours, with specificity around 92% and negative predictive value of 99% throughout. One test covers both non-muscle-invasive and muscle-invasive bladder cancer.

Clinically developed and validated

GALEAS Bladder is the result of more than a decade of research led by the University of Birmingham, with around 7,000 patient samples tested and validation across multiple NHS trusts. The underlying biomarkers were identified by Professor Rik Bryan and Dr Doug Ward at the University of Birmingham, and the test is processed in a UK laboratory accredited to ISO 15189:2022 by UKAS (Medical Laboratory No. 22262) — the same quality standard the NHS requires.

Who should consider this test

• Anyone with blood in their urine, whether visible or detected on a test
• Smokers and ex-smokers (smoking is a leading bladder cancer risk factor)
• People with occupational exposure to dyes, rubber or industrial chemicals
• Anyone over 50 wanting routine peace of mind
• People monitoring for recurrence after previous bladder cancer treatment (alongside their specialist's plan, not as a replacement)

Important note

Visible blood in the urine (haematuria) should always be discussed with your GP urgently, regardless of any home test result. GALEAS Bladder is a screening and triage tool, not a substitute for medical assessment, and a positive result is not a diagnosis of cancer — only further investigation, such as cystoscopy, can confirm that.

How it works

• Order & receive — Free UK delivery within 2 working days. Your urine collection kit is included.
• Provide your sample — Collect a urine sample at home using the included container. Takes about a minute.
• Receive your results — Your lab-verified molecular analysis report appears in your secure account within 10–14 days.

[Note: your brochures quote an average laboratory turnaround of ~7 working days. The 10–14 day figure presumably covers postage both ways plus analysis. Keep whichever you can reliably meet — just make sure it's consistent across the site.]

What the test looks at

GALEAS Bladder is an NGS panel targeting the promoter and exonic regions of 23 of the most relevant genes associated with bladder cancer. Three of the key markers:

• TERT promoter — mutated in over 75% of bladder tumours
• FGFR3 — patients with this mutation are typically around 5× more likely to have non-muscle-invasive bladder cancer
• TP53 — patients with this mutation are typically around 3× more likely to have muscle-invasive bladder cancer

Full gene list: AKT1, BRAF, C3orf70, CDKN1A, CDKN2A, CREBBP, CTNNB1, ELF3, ERBB2, ERBB3, ERCC2, FBXW7, FGFR3, HRAS, KDM6A, KRAS, NRAS, PIK3CA, RHOB, RXRA, SF3B1, TERT (promoter), TP53.

The somatic mutations covered by the panel have been shown to be present in 96% of 956 bladder cancers. [Note: this is the figure from your newest brochure (V4.1). Your current page says "451 somatic mutations… 96% of bladder cancers in over 644 clinical samples." Pick one consistent version — I've used the most recent.]

Further information on these genes: Ward DG et al., European Urology Oncology, 2023 — https://www.sciencedirect.com/science/article/pii/S2588931122000360

FAQ

Is GALEAS a replacement for a cystoscopy? No. Cystoscopy remains the gold standard for diagnosing bladder cancer. GALEAS Bladder is a screening and triage tool — if your result is positive, your GP will likely refer you for further investigation.

What does a positive result mean? It means molecular markers associated with bladder cancer were detected and further investigation is recommended. It does not confirm cancer — only further tests can do that.

How accurate is it? In real-world UK NHS data, GALEAS Bladder showed 92.2% sensitivity, 92% specificity and a 99.3% negative predictive value — performance comparable to cystoscopy.

Can I take this if I have a UTI? We recommend waiting until any urinary tract infection has been fully treated before testing, as infections can affect results.

Is this the same technology used by the NHS? GALEAS Bladder technology has been developed and evaluated within NHS clinical pathways. The exact protocols and use cases differ between home use and clinical settings.

Genes tested:

AKT1, ERBB2, NRAS,BRAF, ERBB3 ,PIK3CA
C3orf70, ERCC2, RHOB
CDKN1A, FBXW7, RXRA
CDKN2A, FGFR3, SF3B1
CREBBP, HRAS, TERT (promoter)
CTNNB1, KDM6A, TP53
ELF3, KRAS

Further information regarding these genes can be found here

Biomarkers were identified by Prof Rik Bryan and Dr Doug Ward at Birmingham
University, UK.
• NGS sequencing panel that targets promoter and exonic regions of 23 of the
most relevant genes associated with bladder cancer
• Identified by a combination of publicly available data and deep exome
sequencing
• Exome studies were performed on Caucasian populations
• 451 somatic mutations present in the panel have been shown to detect 96%
of bladder cancers in over 644 clinical samples.