A pioneering urine test trialled at Southampton's university hospitals is set to revolutionise clinicians' ability to diagnose bladder cancer by providing results within three hours.
Known as ADXBLADDER, it works by detecting a protein – minichromosome maintenance complex component 5 (Mcm5) – which is shed into urine by bladder and prostate tumours.
A UK-led multi-centre study of 577 patients, including from University Hospital Southampton NHS Foundation Trust, showed the test correctly identified 95% of intermediate and high risk cancers and provided an accurate negative result in 97% of cases.
The results, which were presented at the Société Internationale D'Urologie meeting in Portugal on Saturday, compared ADXBLADDER to the current benchmark of combined results from cystoscopy, ultrasound and CT scanning for patients referred to urology clinics due to blood in their urine.
Bladder cancer is the seventh most common type in the UK, with around 10,000 people diagnosed every year. Around two-thirds of cases recur within five years, so patients are monitored routinely after treatment.
Patients are currently tested and monitored via an invasive cystoscopy examination, which involves passing a thin device through the urethra - the tube which carries urine out of the body - to examine the inside of the bladder.
However, urinary tract infections (UTIs) occur in up to 5% of cases undergoing cystoscopy and, used on its own, can miss up to 30% of bladder tumours, so patients often also require an ultrasound and, in some high risk cases, a CT scan.
“There is an urgent and unmet need for a speedy, non-invasive test that would allow for more screening and enable earlier detection of bladder cancer, with patients currently referred to hospital to undergo a cystoscopy and, potentially, also an ultrasound and CT,” explained Tim Dudderidge, a consultant urological surgeon at Southampton General Hospital.
“This is a simple test which provides a yes or no answer according to whether or not there has been a colour change in the Mcm5 protein within around three hours with no need for samples to be sent to specialist laboratories.”
Mr Dudderidge added the test could also transform ongoing care for patients who have been treated for high risk bladder cancer and require regular monitoring for recurrence.
“Such high risk patients can be required to undergo cystoscopy testing up to every three months initially and then for the rest of their lives,” he said.
“Given the choice most would adopt a urine test in a heartbeat if they thought it offered a safe alternative to invasive cystoscopy.”
Posted on Monday 23 October 2017