Arquer Diagnostics Ltd, Sunderland, UK, has announced the start of a 6-month clinical study to optimize the effectiveness of the company’s Mcm5 ELISA test for the diagnosis of recurrent bladder cancer.
The study will be led by Tim Dudderidge, MBChB, a urological surgeon at Southampton General Hospital. It follows on from a recent successful screening trial involving 350 hematuria patients. That study concluded that the Mcm5 ELISA test has a sensitivity of 83%, specificity of 77%, and negative predictive value of 98%.
Because roughly 65% of bladder cancer cases recur within 5 years, patients are routinely monitored on a periodic basis after treatment. Currently, this is done using cystoscopy, which is expensive and uncomfortable for patients. Arquer is developing a simple urine-based test that aims to reduce the number of cystoscopies that each bladder cancer patient must undergo.
“There is currently an unmet need for a test that would allow for more screening and enable earlier detection of bladder cancer,” says Dudderidge. “The Mcm5 ELISA test has the potential to provide patients with a simple and noninvasive solution for screening, and for the detection of recurrence.”
Ian Campbell, PhD, Arquer Diagnostics.
Arquer’s Mcm5 ELISA test detects the presence of minichromosome maintenance complex component 5 (Mcm5) protein in urine. Mcm proteins are shed into urine by both prostate and bladder tumors and are known to be excellent biomarkers of cancer—being directly involved in cell replication.
Arquer’s test originates from work conducted by Cambridge University and Cancer Research Technology (CRT), the development and commercialization arm of Cancer Research UK. It has been improved significantly during the past couple of years by the Arquer team, led by CEO Ian Campbell, PhD, and Chairman Sandy Primrose, PhD, MBE.
The new study will involve at least 40 patients previously diagnosed with bladder cancer. The level of Mcm5 in their urine will be measured prior to treatment, and each time they return for follow-up over a 6-month period. It is hoped that the study will demonstrate the utility of the Mcm5 ELISA test both as a bladder cancer screening tool, and for the detection of bladder cancer in patients previously diagnosed and treated for the condition.
“We are committed to improving outcomes for bladder and prostate cancer patients,” says Campbell. “At present, over 150,000 cases of bladder cancer are diagnosed in Europe annually, and this number is increasing. The health economic benefits of our Mcm5 ELISA test would enable accurate, noninvasive, close monitoring of the disease at low cost.”
For further information, visit Arquer Diagnostics.
