Arquer Diagnostics Signs Manufacturing and Supply Agreement with Euro Diagnostic

Arquer Diagnostics Ltd (Arquer) 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.