Arquer recruits 801 for bladder cancer diagnostic trial
SUNDERLAND, U.K.—Recruitment for a clinical trial of Arquer Diagnostics Ltd.’s MCM5 bladder cancer diagnostic has been completed, the company announced recently. The study is expected to confirm results from a feasibility study that suggested the MCM5 ELISA outperforms other noninvasive bladder cancer diagnostic tests currently in use, in both sensitivity and specificity. The test provides a diagnosis by detecting the presence of minichromosome maintenance protein, which marks the presence of dividing cancer cells and is shed into urine by bladder and prostate tumors. Study results will support Arquer’s application for CE mark approval for the test, which is expected to be launched commercially in Q3 2017.
“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,” commented Nadia Whittley, Arquer Diagnostics’ CEO.