An observational study in the UK has just produced substantially positive results for a new, non-invasive, genetic urine test for bladder cancer.
Demonstrating extremely high accuracy for negatively diagnosing bladder cancer, it also correctly identified bladder cancer-associated genes in 71 of 77 patients who went on to develop a malignancy.
The study authors acknowledged several limitations, while nevertheless pointing out that cystoscopy, the current standard test method, is expensive and time-consuming compared to the remarkable ease with which a patient can provide a simple urine sample.
Bladder cancer is one of the 10 most common malignancies, with some 550,000 cases diagnosed worldwide every year. It’s the 6th most common cancer in the United States, and the CDC estimates that some 84,000 people will develop it this year.
A key symptom in diagnosing bladder cancer is hematuria, the medical term for having blood in one’s urine. Although hematuria is present in more than 90% of the patients diagnosed with cancer, only 8–19% of hematuria referrals ever result in a positive test.
This enormous shortfall between symptom and testing comes in part because of the complexity in the current gold standard testing method. Flexible cystoscopy, urinary tract imaging, and analysis of resected tissue, when combined is considered the highest quality testing procedure, but it goes without saying that these are expensive, invasive, and require in-person attendance and availability for not only the patient, but the medical facility and the urologist.
GALEAS Bladder, developed by Nonacus Clinical Services, subjects a simple urine sample to a sophisticated multimarker genetic assay of proteins and other traces of 23 genes associated with bladder cancer.
As well as being quick and inexpensive, a huge advantage with GALEAS is that it can be run with urine samples collected for other reasons, potentially revealing early signs of bladder cancer in individuals that weren’t considered at risk before.
“The most important message for the patient is that they don’t have to do anything to be part of this,” states Andy Goffe, a Lead Urology Nurse Consultant at Dorset County Hospital Foundation Trust in the UK who leads the GALEAS Bladder service evaluation.
“We also explain that we’re looking for ways to replace a cystoscopy, so perhaps it is not a surprise that, to date, 100% of patients have agreed to get involved.”
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In the recent study published in European Urology Oncology, 964 patients who were referred for urgent hematuria screening as part of a suspected cancer pathway between 2024 and 2025 had their urine samples examined and recorded.
All participants underwent standard diagnostic procedures, as well as the GALEAS test.
Out of 77 cases of bladder cancer identified through cystoscopy, GALEAS detected 71, including all 17 muscle-invasive cancers, and 35 of the 36 later-stage cancers. The negative predictive value, that is, it’s accuracy when not finding anything, was greater than 99%.
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It produced 61 false-positives, and of the 6 false-negatives, 4 cases came when the cancer tumor was at a very early stage. As a triage device, the authors opined, the test demonstrated considerable reliability, efficacy, and accuracy.
“Ultimately, this could lead to a considerable reduction in the number of urgent cystoscopies undertaken in this setting, thereby reducing waiting times.”
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