The research ethics committee of the UK Health Research Authority has recently granted ethical approval for Arquer Diagnostics Ltd, Sunderland, UK, to commence a 6-month clinical study using its enzyme-linked immunosorbent assay (ELISA) to test urine specimens for cancer.
Commencing in early 2016, the new study is intended to provide the data necessary for regulatory approval and registration of the company’s minichromosome maintenance complex component 5 (Mcm5) ELISA test for the diagnosis of bladder cancer.
Led by Stuart McCracken, MD, clinical lecturer and honorary consultant urologist at Newcastle University and Sunderland Royal Infirmary, the study will involve 800 patients with hematuria across at least five centers in the UK, making it the country’s largest privately funded bladder cancer trial. The research will build on findings of a recent successful screening trial involving 350 hematuria patients, which indicated that the Mcm5 ELISA test has a sensitivity of 83%, specificity of 77%, and negative predictive value of 98%.
The company’s urine test detects the presence of Mcm5 protein, which is shed into urine by prostate and bladder tumors. Mcm5 is known to be an excellent biomarker of cancer, as it is directly involved in cell replication. Arquer’s diagnostic test originates from work conducted by Cambridge University and Cancer Research Technology, the development and commercialization arm of Cancer Research UK, and has been further developed by the Arquer team led by CEO Ian Campbell, PhD, and Chairman Sandy Primrose, PhD.
Results of study participants’ Mcm5 tests will be compared with the outcome of their routine investigations, specifically whether their hematuria was caused by bladder cancer. The aim is to show that the Mcm5 ELISA can accurately distinguish between those patients with and without bladder cancer at a point prior to them undergoing invasive techniques such as cystoscopy.
“This is a pivotal study ahead of the commercial launch of Arquer’s Mcm5 ELISA test,” says Campbell. “Ultimately we aim to reduce the number of people without bladder cancer who have to undergo cystoscopy unnecessarily. Cases of bladder cancer are increasing, and there is a need for a reliable up-front test that would enable earlier detection and diagnosis. The Mcm5 ELISA test has the potential to provide patients with a simple and noninvasive solution for screening.”
“Almost 11,000 patients are diagnosed with bladder cancer in the UK each year, with only 53% surviving more than 5 years,” says McCracken. “There is an urgent need to find and validate a novel and acceptable test that can help doctors to pick up bladder cancer at an early stage of the disease process, when currently available treatment options can improve survival rates. I believe we may have found such a test, and am very excited to be collaborating on this study. If successful, this simple, noninvasive urine test would be of benefit to both my patients and my fellow clinicians.”
For more information visit Arquer Diagnostics.