Non-invasive aid for bladder cancer diagnosis

28th March 2018

Results presented at the 33rd Annual EAU Congress showed that ADXBladder - a new non-invasive urine test for bladder cancer from Arquer Diagnostics - can provide very reliable diagnostic results in as little as three hours. A prospective, multi-centric study involving 577 patients showed the test was extremely reliable, demonstrating a sensitivity of 95% for higher risk cancers and an overall negative predictive value greater than 97%. 

“ADXBladder is a real game-changer in the field of bladder cancer testing,” said Mr. Stuart McCracken, the study principal investigator and Urology Surgeon from Newcastle University and Sunderland Royal Hospital, UK. “Our data demonstrates it has one of the highest sensitivities and negative predictive values of any urine test for bladder cancer diagnosis and additionally offers innovative features, such as the result being unaffected by urinary tract infections and no requirement for samples to be sent away to specialist labs for analysis. This will offer NHS the possibility to potentially save a lot of money while diagnosing bladder cancer patients more reliably.”

The test measures levels of the MCM5 protein, which is a marker of cells that are replicating, or still have the capability to replicate (i.e. are not terminally differentiated). Such cells are normally only found in basal layers of the epithelium, but when a mass of replicating cells is present (as occurs in bladder cancer), MCM5 cells are shed into body fluids. MCM5 in the urine is indicative of undifferentiated cells in an inappropriate location. Detection uses standard Enzyme Linked Immunosorbent assay (ELISA) methodology, using mouse monoclonal antibodies to identify MCM5 antigens. 

An important feature is that it is not influenced by infections or inflammation. Bacteria do not contain MCM5 proteins and inflammatory cells are already differentiated, therefore do not express the MCM5 protein.

“ADXBladder has the potential to make non-invasive testing for bladder cancer a clinical reality. It could help to diagnose patients earlier in the disease and offer dramatic improvements in quality of life and safety by reducing the need for cystoscopy and CT scanning,” said Mr. Tim Dudderidge, a study investigator and consultant urologist at Spire Southampton Hospital. “This will have a big impact not only for urologists, who will be able to give more reliable cancer diagnoses, but also for the NHS as it will improve diagnostic speed and accuracy whilst conserving resources."





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