A novel, non-invasive urine test for bladder cancer
27 Oct 2017
by ecancer reporter Janet Fricker
A study presented at the 37th Société Internationale D’Urologie (SIU) meeting Lisbon, Portugal, has demonstrated that a new urine test for bladder cancer has high sensitivity and negative predictive values, opening the way for non-invasive testing to be incorporated into the diagnostic pathway.
The test, called ADXBladder, employs Enzyme-linked immunosorbent assay (ELISA) technology which is available in most hospitals, and requires just 10 mL of urine to deliver a definitive ‘yes/no’ results within three hours.
In 2012 in Europe 151,000 people were diagnosed with bladder cancer and 52,000 died from the condition.
For diagnosis, the European Association of Urology (EAU) currently recommend cystoscopy for all patients with haematuria, in conjunction with CT urography (in selected high-risk patients) or renal and bladder ultrasound.
Currently cystoscopy cannot be replaced by cytology or any other non-invasive tests.
For bladder cancer testing most current diagnostic approaches have disadvantages.
Cystoscopy is an undignified, invasive and uncomfortable procedure with around a 5% risk of causing UTIs; interpretation of cytology is user dependent; and CT urograms expose patients to ionizing radiation.
In the current study, between August 2016 and February 2017 577 patients attending diagnostic haematuria clinics at six UK centres underwent ADXBLADDER testing, with results then compared to the current diagnostic benchmark of combined cystoscopy, ultrasound and CT scanning.
The test uses standard ELISA methods to measure levels of MCM5, a protein marker of replicating cells, or cells which have the capability to replicate.
The key to the new test is that healthy cells which line the bladder (and are in contact with the urine) are terminally differentiated and so do not contain MCM5, while cancer cells are replicating cells and therefore do contain MCM5, so when these cells are shed into the urine MCM5 can be detected in the urine of cancer patients, but not in normal urine.
“This is a real game changer in the field of bladder cancer testing. Our data demonstrates this test 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 (UTIs), inflammation or the presence of blood,” said Mr. Stuart McCracken, the study presenter a Urology Surgeon from Newcastle University and Sunderland Royal Hospital, UK