Arquer Diagnostics won £70,000 (approximately $86,600) of funding from Innovate UK’s Biocatalyst program to support development of its MCM5 enzyme-linked immunosorbent assay (ELISA)-based urine test for diagnosing prostate cancer. The funds will support a 100-patient study to aid in the design of a large-scale international clinical trial, which is projected to start during late 2017. 

Arquer has previously completed a clinical trial with the MCM5 ELISA test for diagnosing bladder cancer. The firm, which changed its name from UroSens to Arquer in 2015, indicated to GEN that the bladder cancer trial data will be analyzed for CE marking prior to EU launch of the MCM5 ELISA test for bladder cancer, which is projected for 2017. The planned prostate cancer study will gather the clinical data for CE marking the prostate indication of the kit.

MCM5 ELISA detects minichromosome maintenance protein (MCM) as a biomarker for dividing cancer cells. Arquer says the protein can be found in the urine of both prostate and bladder cancer patients. “The MCM5 ELISA is expected to significantly reduce the number of patients undergoing invasive and costly techniques such as cystoscopy and biopsy, because it offers highly accurate diagnostic results from small amounts of body fluid,” commented Nadia Whittley, who was appointed Arquer CEO in December 2016.

“There is an urgent need to find, and robustly validate, a novel cancer biomarker of prostate cancer,” added Stuart McCracken, Ph.D., consultant urologist at Sunderland Royal Hospital, U.K., and U.K. clinical investigator for the prostate cancer study. “Studies such as this provide evidence that may support a change in the diagnostic pathway and start to allow reductions in expensive and unnecessary prostate biopsies which are very unpopular with patients and are a major financial burden to healthcare providers.”