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Pioneering genetic test for bladder cancer made available to speed up detection and reduce uncomfortable hospital procedures

Informed Genomics Limited and Bupa insurance have collaborated to make a pioneering genetic test for bladder cancer available for the first time in the UK.

Currently, people who are suspected of having bladder cancer are referred for a cystoscopy – an uncomfortable hospital procedure that involves a camera being passed through the urethra to the bladder.

The new GALEAS™ Bladder test detects bladder cancer by picking up genetic markers in urine samples, which patients can provide from the comfort of their own home. The sample is then posted for genetic analysis to the Informed Genomics’ ISO 15189 accredited lab, and results are shared with the patient’s doctor.

The test can detect genetic mutations associated with 96 per cent of bladder cancers at all stages and grades – equivalent results to cystoscopy[1].

Of all patients currently referred for cystoscopy, only 10 per cent are diagnosed with bladder cancer[2]. The GALEAS Bladder test could move the 90 per cent of patients without cancer to a non-urgent pathway, freeing up resource for patients to undergo cystoscopies faster to confirm their cancer diagnoses. It is estimated these genetic tests will cost health systems significantly less than cystoscopies[3]

Dr Tim Woodman, Medical Director for Cancer Services at Bupa said: “We’re pleased to be partnering with Informed Genomics to be the first UK health insurer to cover the GALEAS Bladder test for our customers. It provides a more efficient solution to diagnosing bladder cancer, where getting that diagnosis a few days or weeks earlier could make a crucial difference.”

Around 20,500 people are diagnosed with bladder cancer in the UK every year[4], and it leads to around 5,500 deaths annually.[5]

Early diagnosis of the disease is crucial – more than 80 per cent of people diagnosed at the earliest stage survive at least five years compared to less than 10 per cent diagnosed at the latest stage[6].

The test uses highly sensitive liquid biopsy technology and a panel of biomarkers developed by researchers at the University of Birmingham. Prof Rik Bryan, Professor in Urothelial Cancer Research said: “I am delighted to see our urine test now being implemented by Informed Genomics Limited and adopted by healthcare providers such as Bupa. In parallel, and with the support of Cancer Research UK, my colleagues and I at the Bladder Cancer Research Centre at the University of Birmingham are focusing on designing and delivering clinical studies within a number of bladder cancer settings so that NHS adoption can follow suit.”

The next generation sequencing (NGS) technology involved in the GALEAS Bladder test detects the commonest somatic mutations associated with bladder cancer[7] – mutations that develop over time and are not inherited at birth – across 23 genes.

Mr Chris Blick, Consultant Urologist at the Royal Berkshire Hospital said: “It is incredibly exciting to see the successful transition from bench to bedside of a novel, non-invasive biomarker with high diagnostic accuracy. This test has the potential to alter the way patients are investigated and managed during their bladder cancer journey.”

Dr Lydia E Makaroff, Chief Executive at Fight Bladder Cancer said: “A non-invasive test, used alongside cystoscopies, is something patients have been asking for; having one accurate enough to reduce the number of cystoscopies would represent a significant improvement for patients.”

Tony Hickson, Chief Business Officer at Cancer Research UK, said: "As funders of the research behind the GALEAS Bladder test, we are delighted at the news that it will be made available to patients across the UK - giving people access to a more convenient, non-invasive way to screen for bladder cancer."

Jeannie Rigby, Chief Executive of Action Bladder Cancer UK, added: “Bladder cancer has long fallen behind in research developments – it is still often diagnosed late, leading to worse outcomes for patients.  It is exciting to see this first step in speeding up the process of diagnosis, which can only be of benefit to patients – and we look forward to seeing this test being made more widely available.”

Lauren Silcock DipRCPath, Clinical Laboratory Director of Informed Genomics, said: “Our cutting-edge technology could spare thousands of patients the discomfort of receiving an unnecessary flexible cystoscopy, whilst freeing up clinicians’ time and resources to deal with the most urgent patients.

“Our collaboration with Bupa is an important first step in making the GALEAS Bladder test available to patients in the UK and around the world. We’re working hard to make the test available more widely, through other healthcare providers and the NHS.”

[1] Ward DG et al. Eur Urol Oncol, 2023, Highly Sensitive and Specific Detection of Bladder Cancer via Targeted Ultra-deep Sequencing of Urinary DNA / Ward et al. BJU Int, 2019, Targeted deep sequencing of urothelial bladder cancers and associated urinary DNA: a 23-gene panel with utility for non-invasive diagnosis and risk stratification.

[2] Edwards TJ et al. A prospective analysis of the diagnostic yield resulting from the attendance of 4020 patients at a protocol-driven haematuria clinic. BJU Int. 2006 Feb;97(2):301-5.

[3] Data on file – BUPA and Informed Genomics.

[4] Catto JWF et al. Diagnosis, treatment and survival from bladder, upper urinary tract, and urethral cancers: real-world findings from NHS England between 2013 and 2019. BJU Int. 2023 Jun;131(6):734-744.

[5] https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer

[6] https://www.cancerresearchuk.org/about-cancer/bladder-cancer/survival

[7] Ward DG, et al. (2023) Highly Sensitive and Specific Detection of Bladder Cancer via Targeted Ultra-deep Sequencing of Urinary DNA, European Urology Oncology, 6(1): 67-75.

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NHE May/June 2024

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