Arquer Diagnostics, a diagnostic company that has developed a high sensitivity, high specificity, ELISA-based urine test for bladder cancer, has completed the recruitment of 801 patients for a clinical trial to evaluate the company’s MCM5 bladder cancer diagnostic.

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 for Bladder Cancer, which is planned for Q3 2017. 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 utilized in the routine diagnosis of bladder cancer, in terms of both specificity and sensitivity.

Arquer’s non-invasive diagnostic test, the MCM5 ELISA, detects the presence of minichromosome maintenance (MCM) protein, a marker for the presence of dividing cancer cells, to accurately diagnose cancer. MCM proteins are excellent biomarkers, being directly involved in cell replication, and are shed into urine by both prostate and bladder tumors.

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 analyzed 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.”