Study Could Lead to Approval of Test for Bladder Cancer

Ethical approval to undertake a six month clinical study has been announced by Arquer Diagnostics Ltd for its ELISA-based urine test for cancer. A Health Research Authority Research Ethics Committee (REC) has approved the project’s Protocol and 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.

Due to commence early this year it 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. Led by Dr Stuart McCracken, Clinical Lecturer and Honorary Consultant Urologist, Newcastle University and Sunderland Royal Infirmary, it 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%.

The test originated from work conducted by Cambridge University and Cancer Research Technology and has been improved by Arquer’s CEO, Dr Ian Campbell, Chairman, Dr Sandy Primrose and their team. It detects the presence of minichromosome maintenance complex component 5 (Mcm5) protein in urine and could offer a means to distinguish between those patients with and without bladder cancer at a point prior to them undergoing invasive techniques such as cystoscopy.

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.”