Galeas At Home Bladder Cancer Genome Testing

Location

Description

Hywel Dda University Health Board (HDUHB), Aneurin Bevan University Health Board (ABUHB), and Swansea Bay University Health Board (SBUHB) seek to enter into contract with Informed Genomics Ltd for the delivery of up to 750 at home bladder cancer genome tests (Galeas) as well as the reporting of results to a cloud-based platform. Cancer Research UK’s data shows that bladder cancer is the 9th most common cause of cancer death in the UK, accounting for 3% of all new cancer cases in the UK, with around 2,800 new cases in females and 7,600 new cases for males every year (2017-2019). The NHS Wales National Optimal Pathway (NOP) for bladder cancer has been developed as part of the Single Cancer Pathway (SCP), which aims to establish consistent generic and site-specific pathways that describe all routes of entry onto the pathway from the point of suspicion (PoS) of cancer. Following PoS, a GP referral is made, or referrals are made as a result of incidental findings, ward referrals, or emergency presentation. Where blood is visible and non-visible in urine, patients are referred for testing, necessitating a diagnostic procedure as the first episode of care, typically a flexible cystoscopy procedure. Most diagnostic referrals are to rule out bladder cancer suspicion in patients, with an invasive flexible cystoscopy procedure being undertaken. Following the diagnostic pathway, where bladder cancer is confirmed, the patient will enter the treatment pathway. The Urology Clinical Implementation Network (CIN) has identified a provider in the marketplace, Informed Genomics Ltd., who offer an innovative genome testing kit (Galeas) that can identify bladder cancer through urine samples collected at home. GALEAS Bladder is a simple urine test for bladder cancer that delivers results equivalent to a cystoscopy. A completely non-invasive test, GALEAS Bladder is a sample-to-report urine test developed in partnership with University of Birmingham which uses next generation sequencing to interrogate somatic mutations found across all grades and stages, which detects bladder cancer. A sensitive diagnostic test, the GALEAS Bladder is equivalent to cystoscopy for all grades and stages of bladder cancer, including non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC). Results are reported into a cloud-based GALEAS software, providing clinicians with results digitally. This innovative test offers many benefits, including patient experience, where urine samples can be collected at home in a non-invasive manner, reducing the need to travel for invasive procedures. Patient outcomes will also be improved due to the reduced turnaround time for results (provided within one (1) week of receipt of sample). This timely receipt of diagnostic results will allow clinicians to make informed decisions on patient care and pathways, with treatment provided in a timely manner, reducing the risk of cancer progressing to further stages. Current figures suggest this will reduce current pathway by seven (7) weeks. HDUHB, ABUHB, and SBUHB seek to trial up to 750 tests to be called off over six (6) months. Volumes per Health Board are as follows: HDUHB 300 tests, ABUHB 200 tests, SBUHB 250 tests.

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CPV Codes

• None found

Legal Justification

Whilst there are urine tests in the market that can be used in bladder cancer diagnosis, their intended use differs, which impacts sensitivity, specificity, and NPV. As blood in the urine (haematuria) is the most common sign of bladder cancer, it is imperative that the test has the capability of triaging haematuria at all grades and/or stages. As this area is innovative, there are limited studies and smaller datasets which must be interpreted to provide clinically proven and data-driven assurances of efficacy. Currently, there is only one test available in the UK market designed for haematuria triage, the GALEAS Bladder, with at-home kits.

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