London, UK, 31 August 2018: LifeArc®, one of the UK’s leading medical research charities, proudly announces that its Centre for Diagnostic Development (CDD) has just been accredited by the British Standards Institution (BSI) less than a year since opening in a new location in Edinburgh, Scotland. The CDD is the only LifeArc facility that is focused solely on designing and developing commercially viable molecular diagnostic tests and this new certificate is validation of the high quality of LifeArc’s products.

Dr Michael Dalrymple, Executive Director of Diagnostics and Science Foresight, LifeArc comments: “Our dedicated team here at the CDD is delighted that the quality of our work has been recognised by the BSI and we hope this is very reassuring for our current and future partnerships. We have always provided an efficient and tailored diagnostic service for our partners and we hope that this certificate provides appropriate quality assurance that is needed to attract additional research projects from the thriving medical research community we are lucky enough to be a part of here in Edinburgh and beyond.”

The centre’s main aim is to pioneer the design and development of molecular in vitro devices (IVDs), thereby turning great science into even greater patient impact.

LifeArc continuing focus will be the design and development of molecular diagnostic tests focusing on oncology, infectious disease and precision medicine. Potential partners will benefit from LifeArc’s expertise and industry experience and introductions to potential industry partners. If you would like to know more about LifeArc’s diagnostic development capability please click here.


Glenn Mursell
Communications at LifeArc
Tel: 02073912754

Notes to editors

About LifeArc

LifeArc® is a medical research charity that pioneers new ways to turn great science into greater patient impact. The charity has a 25 year legacy of helping scientists and organisations advance their research into therapeutics and diagnostics for patients, including Keytruda®(cancer), Actemra® (rheumatoid arthritis), Tysabri® (multiple sclerosis) and Entyvio® (Crohn’s disease) and a test for antimicrobial resistance. Find out more about how LifeArc funds, protects and develops much needed research at or follow @lifearc1 on Twitter.

About the ISO certification

The BSI medical device standard that LifeArc’s CDD has achieved is ISO 13485:2016 and EN ISO 13485:2016. This relates specifically to the management system for the design and development of nucleic acid in vitro diagnostic tests for precision oncology, and infectious disease diagnosis and monitoring. To achieve this certification, the CDD underwent a thorough two-stage certification audit which was conducted by the BSI. During this, the CDD demonstrated that its design and development processes conform to the high standards of the internationally recognised certification body. This comes after the ISO 13485:2016 and EN ISO 13485:2016 standards were recently enhanced to meet the stringent regulations and demanding requirements of the medical device industry.