Euro Diagnostica AB signs Manufacturing and Supply Agreement with Arquer Diagnostics Ltd

February 8, 2016 - Company News
MALMÖ, Sweden, 08 February, 2016 — Euro Diagnostica AB (Euro Diagnostica) has signed an agreement for the manufacturing and supply of Arquer Diagnostics Ltd (Arquer)’s Mcm5-ELISA test for the diagnosis of bladder cancer.

Bladder cancer is currently diagnosed by cystoscopy, which is expensive and uncomfortable for patients.  Arquer has developed a high sensitivity, high specificity, ELISA-based 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).

“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. As a manufacturer, Euro Diagnostica can offer tailored technical state-of-the art solutions based on experience and competence. We look forward to a mutually successful long-term business relation.” says Else Beth Trautner, CEO, Euro Diagnostica

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.”

Under the terms of the agreement, Euro Diagnostica will be the primary manufacturer of Arquers´ Mcm5-ELISA test kits.

Click here to download the press release

About Euro Diagnostica AB

Euro Diagnostica facilitates the development of safe and efficient drugs and optimal treatment of patients by providing cutting edge assays. By offering versatile assay solutions to pharma, biotech and CRO customers Euro Diagnostica is an optimal partner in drug development from the exploratory phase to and beyond clinical trials. We also provide clinical labs and physicians with cutting-edge tools to aid in diagnosis, prognosis, monitoring and treatment of inflammatory and related diseases.

With 20 years of experience we provide optimized development and production services. Since we combine R&D, manufacturing and administration under one roof in Malmö, Sweden, we are able to offer our customers reliable and favourable solutions matching their assay development and manufacturing needs.Read more about our custom manufacturing offering. 


   Else Beth Trautner
   P: +46 (40) 53 76 85


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.  MCM proteins are excellent cancer biomarkers - being directly involved in cell replication, and are shed into urine by both prostate and bladder tumours.  Arquer’s technology originates from work carried out by Cambridge University and Cancer Research Technology (CRT), the development and commercialisation arm of Cancer Research UK.

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.

For more information please visit


   Lorna Cuddon, Zyme Communications
   P: 07811 996 942


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