Arquer Diagnostics, the developer of a high-sensitivity, high-specificity, enzyme-linked immunosorbent assay (ELISA)-based urine test for bladder cancer, has recruited 801 patients for a clinical trial to evaluate the company’s MCM5 bladder cancer diagnostics test. The results from the study will be used as part of the company’s application for CE mark approval, ahead of the commercial launch of the MCM5 ELISA planned for later in the year.
The study is expected to confirm the results obtained in a recent feasibility study, which indicated that the MCM5 ELISA performs well above other non-invasive diagnostic tests currently utilised in the routine diagnosis of bladder cancer, in terms of
both specificity and sensitivity. Arquer’s MCM5 ELISA detects the presence of minichromosome maintenance (MCM) protein, a marker for the presence of dividing cancer cells, which is shed into urine by both prostate and bladder tumours.
Nadia Whittley (CEO, Arquer Diagnostics), commented: “I am extremely excited about reaching this important milestone. While we will have to wait for the samples to be analysed and the results to be presented, this is really the last step before making this novel diagnostic test available to bladder cancer patients in many countries worldwide.”