Image: The ADXBLADDER MCM5 ELISA kit for the diagnosis of bladder cancer (Photo courtesy of Arquer Diagnostics).
In Europe, bladder cancer represents the fourth most common cancer in men and the 15th most common cancer in women, with 151,000 people diagnosed with the condition in 2012. In order to make a bladder cancer diagnosis, experts currently recommend cystoscopy for all patients with hematuria, in conjunction with computed tomography (CT) urography (in selected high-risk patients) or renal and bladder ultrasound.
At the moment, cystoscopy cannot be replaced by cytology or any other noninvasive tests. Most bladder cancer diagnostic approaches have disadvantages; cystoscopy is an undignified, invasive, and uncomfortable procedure exposing patients to the risk of developing urinary tract infections (UTIs), which are known to occur in around 5% undergoing cystoscopy. Cytology is known to have a low sensitivity and its interpretation is dependent on the user, while CT urogram exposes patients to ionizing radiation.
Urologists at the Northern Institute for Cancer Research (Newcastle Upon Tyne, UK) carried out a prospective blinded study involving 577 hematuria patients in clinics at six centers across the UK between August 2016 and February 2017,who underwent the novel non-invasive testing, with results then compared with the current diagnostic benchmark of combined cystoscopy, ultrasound, and CT scanning.
The team used the ADXBLADDER test that employs standard Enzyme Linked Immunosorbent assay (ELISA) methodology to measure levels of Minichromosome Maintenance Complex Component 5, (MCM5), which is a protein marker of replicating cells, or cells that have the capability to replicate. The test requires just 10 mL of urine and delivers definitive "yes/no" results within three hours.
The ADXBLADDER test received its CE Mark on October 11, 2017. The results of the study showed that 7.96% of the tests were positive for cancer and 92.1% negative. When ADXBLADDER was compared to the gold standard the investigators found that the test correctly identified 95% of patients with high-risk cancers, and that the negative predictive value (the test’s ability to correctly identify patients without cancer) was 97%.
Stuart McCracken, MD, a Consultant Urological Surgeon and the principal investigator, said, “The ADXBLADDER test offers a real game changer in bladder cancer diagnosis. The results of our new study, demonstrating fantastic accuracy, open the way for non- invasive bladder cancer testing to become widespread. This test undoubtedly has a role to play in helping identify women with bladder cancer early which could have a positive impact on survival.” The study was presented at the 37th Société Internationale D'Urologie (SIU) meeting, held October 19-22, 2017, in Lisbon, Portugal.
Northern Institute for Cancer Research