Arquer Diagnostics, a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for cancer, has announced that it has received ethical approval to commence a six month clinical study. This is awarded by a Health Research Authority Research Ethics Committee (REC) and is the approval of the project’s Protocol. The new study will provide the data necessary for regulatory approval and registration of the company’s Mcm5-ELISA test for the diagnosis of bladder cancer.
The study will commence in early 2016 and will involve 800 patients with haematuria, across at least five centres in the UK, making it the country’s largest privately funded bladder cancer trial. It will be led by Dr Stuart McCracken, Clinical Lecturer and Honorary Consultant Urologist, Newcastle University and Sunderland Royal Infirmary, and follows on from the recent successful screening trial involving 350 haematuria patients, which indicated the Mcm5-ELISA test has a Sensitivity of 83%, Specificity of 77% and Negative Predictive Value of 98%.
Bladder cancer is currently diagnosed by cystoscopy, which is expensive and uncomfortable for patients. Arquer’s Mcm5-ELISA is a simple, non-invasive test, which detects the presence of minichromosome maintenance complex component 5 (Mcm5) protein in urine. MCM proteins are shed into urine by both prostate and bladder tumours and are known to be excellent biomarkers of cancer, being directly involved in cell replication. Arquer’s diagnostic test originates from work conducted by Cambridge University and Cancer Research Technology (CRT), the development and commercialisation arm of Cancer Research UK, and has been improved significantly during the last couple of years by the Arquer team led by CEO, Dr Ian Campbell and Chairman, Dr Sandy Primrose.
The new study will involve testing for the presence of MCM5 in the urine of 800 patients with haematuria. The result of their MCM5 test will be compared with the outcome of their routine investigations, specifically whether their haematuria 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.
Dr Ian Campbell, CEO, Arquer Diagnostics, commented: “This is a pivotal study ahead of the commercial launch of Arquer’s Mcm5-ELISA test. 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 non-invasive solution for screening.”
Dr Stuart McCracken, Principal Investigator, commented: “Almost 11,000 patients are diagnosed with bladder cancer in the UK each year, with only 53% surviving more than 5 years. 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, non-invasive urine test would be of benefit to both my patients and my fellow clinicians.”