Test can help urologists rule out bladder cancer in two hours

A test, which uses patented technology to detect MCM5 in urine, could help urologists rule out bladder cancer in as little as two hours.  

At a time when experts from the Institute for Public Policy Research are warning that up to 7,200 excess deaths from cancer could occur due to delays in diagnosis because of COVID-19, it is vital that urologists have the tools to be able to speed up time to diagnosis.

Clinical trials involving over 3,000 bladder cancer patients have shown that ADXBladder, made by UK-based Arquer Diagnostics, is a test enabling which can help exclude the presence of high-risk bladder cancer. Data presented at the European Association of Urology congress at the end of July and published in the Journal of Urology reinforces the clinical trial results investigating MCM5, which show that ADXBladder can exclude the presence of bladder cancer with an NPV of 99% in newly diagnosed patients and those who require recurrence monitoring. 

All cancer cells are continually replicating so contain MCM5. When a tumour is present in the bladder, these cells are shed into the urine and so the urine will contain the MCM5 biomarker. An important feature of ADXBladder is that the test is not influenced by infections or inflammation as bacteria do not contain MCM5 proteins and inflammatory cells cannot replicate so do not express the MCM5 protein. ADXBladder fits in a standard ELISA (enzyme-linked immunosorbent assay) machine widely available in NHS hospital labs.

Pre-COVID, bladder cancer had already been dubbed the ‘Cinderella Cancer’ due to delayed diagnosis, stagnation in treatment options and low levels of research funding. Contrary to NICE guidelines, which state that everyone with any suspected cancer should have their first referral appointment within two weeks, many people can wait up to a year or more to be diagnosed, by which time their cancer has spread beyond their bladder, making treatment difficult and cutting life-expectancy significantly. Figures have revealed that since the COVID-19 lockdown began, this NICE target has slipped by at least 75%. NICE also recommends that all patients with blood in their urine should be offered a cystoscopy, followed up by other tests such as an ultrasound if necessary. However, cystoscopy can miss up to 30% of bladder tumours and is an uncomfortable, invasive and sometimes painful procedure.

Mr Stuart McCracken, clinical lecturer and honorary consultant urologist, Newcastle University and Sunderland Royal Infirmary, said: “COVID-19 has had a devastating impact on cancer services around the country. A simple, non-invasive urine test such as ADXBladder can be used to swiftly identify patients at risk of bladder cancer recurrence, and who require follow-up tests, but also confidently identify those patients not at risk, who can therefore be reassured and reviewed at a later date, when the current COVID-19 risk is lower. We now have a unique opportunity to look at the cancer pathways we are currently using, which have changed completely in a very short period of time. Rather than going back to where we were pre-COVID, there is now an opportunity to change them for the better, building on and perfecting what we have been doing during lockdown.”

Bladder cancer affects more than 10,000 people a year in the UK according to CRUK and kills more than 5,400. Less than half of those diagnosed (46%) survive for 10 years or more.

Experts are now warning that urology departments could take at least a year to get through the backlog if they only use cystoscopies which could lead to those who may have the disease missing out on urgent treatment, with potentially fatal consequences.

Nadia Whittley, chief executive officer of Arquer Diagnostics, said: “We have all heard about the devastating impact that COVID-19 has had on cancer services across the UK. Our ADXBladder test is quick, painless and can rule out bladder cancer with 99% accuracy because it works by detecting a cancer protein which would be shed into the urine if a tumour was present. 

"At a time when urology services are desperately trying to work through a backlog of thousands of patients who are waiting to find out if they have bladder cancer or if their disease has returned, we are offering as many tests as the NHS needs free of charge to quickly determine which patients are clear of the disease and which need further tests.

“Every single person waiting for a diagnosis deserves not to have to wait any longer for peace of mind that they are cancer-free or to be able to begin vital treatment if required. Urologists should get in touch with Arquer Diagnostics as soon as possible and we can then make the tests available to their hospitals and clinics.”