Sunderland, UK, 08 February 2016: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for cancer, has announced that it has signed an agreement with Euro Diagnostica AB (Euro Diagnostica) for the manufacturing and supply of Arquer’s Mcm5-ELISA test for the diagnosis of bladder cancer. Under the terms of the agreement, Arquer intends to use Euro Diagnostica as its primary manufacturer of its Mcm5-ELISA test kits.
Bladder cancer is currently diagnosed by cystoscopy, which is expensive and uncomfortable for patients. Arquer’s Mcm5-ELISA is a simple, non-invasive test, which detects the presence of minichromosome maintenance complex component 5 (Mcm5) protein in urine. MCM proteins are shed into urine by both prostate and bladder tumours and are known to be excellent biomarkers of cancer, being directly involved in cell replication. Arquer’s diagnostic test originates from work conducted by Cambridge University and Cancer Research Technology (CRT).
Dr Ian Campbell, CEO, Arquer Diagnostics, commented: “This agreement is an important milestone for Arquer, as we move towards European regulatory approval and prepare for the commercial launch of the Mcm5-ELISA test later this year. With Euro Diagnostica’s experience in the manufacture of ELISA kits, we are confident that this relationship will allow us to bring the Mcm5-ELISA test to market in the most efficient, rapid, and cost effective manner possible, to benefit both patients and clinicians.”
“It is with great pleasure we engage in this partnership with Arquer, which indeed substantiates Euro Diagnostica’s ambition to be a preferred partner, meeting the ever-growing demands within the IVD/Biotech world. We look forward to a mutually successful long-term business relationship.” said Else Beth Trautner, CEO, Euro Diagnostica.
About Arquer Diagnostics Ltd
Arquer Diagnostics (Arquer) is a venture backed, UK based diagnostics company focused on the development and commercialisation of a non-invasive immunoassay diagnostic test for bladder and prostate cancer. Arquer’s diagnostic test, the Mcm5-ELISA, detects the presence of minichromosome maintenance (MCM) protein, a marker for the presence of dividing cancer cells, in urine by both prostate and bladder tumours.
The non-invasive, urine-based ELISA and Point-of Care tests being developed by Arquer meet the increased demand for cost-effective healthcare technologies that not only enhance patient care but help to reduce overall healthcare costs by improving patient outcomes. 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. Established in 2007, Arquer Diagnostics Ltd is based at the North East Business and Innovation Centre, Sunderland, UK. The management team and Board of Directors have extensive experience in the diagnostic market. Arquer will commercialise ELISA and Point-of-Care urine tests for cancer for use in the urology clinic, hospital lab and the GP’s surgery.
