Bladder cancer test called “GALEAS Bladder” is a DNA-based diagnostic urine test designed to aid in the early detection of bladder cancer. Developed by Professor Richard Bryan and Dr. Doug Ward from the Institute of Cancer and Genomic Sciences at the University of Birmingham, the test targets the most commonly mutated genes in bladder cancer, analyzing 23 genes and identifying 400 to 451 single nucleotide variants.
Compared to the current method of detecting bladder cancer, which involves outpatient flexible cystoscopy, the GALEAS Bladder test has shown similar or slightly better accuracy. Flexible cystoscopy has a sensitivity and specificity of around 85%, but it is an invasive and uncomfortable procedure with potential side effects. In contrast, the GALEAS Bladder test offers a non-invasive alternative that spares patients from the discomfort and potential complications of cystoscopy.
The non-invasive nature of the GALEAS Bladder test also has the potential to expedite the diagnosis process and reduce costs. Patients can provide urine samples at home, which are then sent to the laboratory for analysis. The test results can be obtained within 10 days. Additionally, the projected pricing of the GALEAS Bladder test in the UK is slightly cheaper than flexible cystoscopy, offering a more cost-effective option.
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The impact of the GALEAS Bladder test on bladder cancer diagnosis and treatment could be significant. By acting as a triage test in hematuria clinics, it could spare millions of patients from unnecessary flexible cystoscopies, reducing waiting times and leading to faster diagnoses. In the surveillance of non-muscle invasive bladder cancer, the test has the potential to replace a significant number of cystoscopies, reducing the invasive procedures for patients.
However, the GALEAS Bladder test does have limitations. It relies on next-generation sequencing technologies and requires analysis in a laboratory, which currently limits its use to healthcare facilities. Additionally, while the test has a high sensitivity for detecting bladder cancer, there is a small percentage (around 4%) of bladder cancers that may not have the specific mutations targeted by the test.
The GALEAS Bladder test is currently undergoing clinical trials, including a study funded by Cancer Research UK, to evaluate its effectiveness as a triage tool and to obtain regulatory approvals. The researchers are also exploring the incorporation of copy number data and considering the test’s potential in detecting recurrence in muscle invasive bladder cancer.
Overall, the GALEAS Bladder test shows promise as a non-invasive, accurate, and cost-effective method for early detection of bladder cancer, with the potential to streamline diagnostic pathways and improve patient care.
Professor Richard Bryan, Chief Investigator of the Bladder Cancer Prognosis Programme (BCPP), the SELENIB clinical trial, and POUT-T. He is the Director of the Bladder Cancer Research Centre (BCRC) in the Institute of Cancer & Genomic Sciences. Professor in Urothelial Cancer Research at the University of Birmingham
Doug Ward, PhD, Senior Research Fellow and theme lead for Biomarkers and Proteomics at the University of Birmingham