Urine test identifies more than 9 in 10 bladder cancers, clinical study finds

More than 9 in 10 patients who had bladder cancer were picked up through a non-invasive urine test after urgent referral, a new study finds.

The study led by the University of Birmingham and Nonacus Ltd has worked with 964 patients across seven NHS urology departments to look at the real-world significance of testing for bladder cancer using a commercially available urine test. GALEAS™ Bladder, which tests genomic information from a patient’s urine for traces of bladder cancer, was able to detect 71 of 77 cancers (92.2%) among the nearly 1,000 patients.

The peer-reviewed results which have been published in European Urology Oncology today, and showed significant results for detecting cancer as well as its use as a screening tool.

GALEAS Bladder detected all 17 muscle-invasive bladder cancers (100%) and 35 of 36 high-grade cancers (97.2%) diagnosed during the study. Meanwhile, a negative result was associated with a 99.3% probability of not having bladder cancer.

For the 30% of patients in the study with blood in their urine but which was not visible to the naked eye (non-visible haematuria) GALEAS Bladder identified all bladder cancers (100%) with a negative result associated with a 100% probability of not having bladder cancer.

Professor Richard Bryan, Director of the University of Birmingham’s Bladder Cancer Research Centre and co-author of the study, said: “We have spent many years developing and evaluating the science behind detecting bladder cancer through DNA in urine with support from Cancer Research UK and philanthropists, ultimately leading to the development of the GALEAS Bladder test by Nonacus. This prospective study shows that the very promising early performance has now been reproduced across multiple NHS centres and in a large real-world patient population.

“GALEAS detected 35 of 36 high-grade cancers and every muscle-invasive cancer diagnosed in the study. These results show that molecular urine testing can be used now to help clinicians decide which patients need an urgent cystoscopy and which can safely have that procedure deferred.

“The results are very significant for clinical practice. Only 8% of patients in the study were ultimately diagnosed with bladder cancer, which highlights the challenge facing NHS haematuria services where large numbers of patients currently enter the same urgent diagnostic pathway despite most not having cancer. GALEAS is a promising and less invasive test that can be easier to administer and make testing and screening for bladder cancer far easier.”

Simple to administer test

The GALEAS test was used in the study alongside a typical way to test for bladder cancer using a technique called cystoscopy. In a cystoscopy test, a camera is passed through the urethra to examine the bladder. The procedure is an important part of bladder cancer diagnosis, but Professor Bryan, a former clinical urologist notes that the procedure is invasive and resource intensive.

GALEAS Bladder uses DNA found in a urine sample to help clinicians identify patients at greater risk who should be prioritised for urgent cystoscopy, while allowing cystoscopy to be deferred for some patients at lower risk where clinically appropriate.

Lee Silcock, Co-founder and Chief Product Officer at Nonacus and co-author of the study, said: “Seeing GALEAS perform so strongly across almost 1,000 patients in seven NHS urology departments is extremely encouraging. This is real-world evidence from the patients and pathways the test has been designed to support."

“What matters most is identifying those most likely to have cancer sooner, while giving clinicians confidence when deciding which patients can safely wait for a cystoscopy. The fact that the test detected every muscle-invasive cancer in the study, alongside a negative predictive value of more than 99%, gives us further confidence in the role GALEAS can play in supporting NHS diagnostic pathways”

Already reducing the burden on urology departments

The study also found that incorporating urine-based testing in bladder cancer pathways could reduce the burden on urology departments. At the most cautious pre-specified clinical threshold, using GALEAS Bladder to triage patients was estimated to result in 730 fewer urgent cystoscopies for every 1,000 patients, compared with urgent cystoscopy for everyone, with no loss of net clinical benefit.

GALEAS Bladder is already being used within NHS pathways in England and Wales, with further NHS sites adopting the test as clinical use expands.

The full study, Real-World Multicentre Evaluation of GALEAS™ Bladder for Detecting Bladder Cancer in UK NHS Haematuria Clinics, is published in European Urology Oncology and available online now.