Dxcover® secures ISO 13485 certification

Dxcover Limited, developer of liquid biopsies for the early detection of cancer, has secured ISO 13485:2016 certification for its Quality Management Systems in relation to the design, development, and production of its liquid biopsy platform.


ISO 13485 is an internationally recognised quality standard specific to the medical device industry. The certification scope earned by Dxcover covers the design and development of in vitro diagnostic liquid biopsies and software for the triage of cancer in symptomatic patients based on infrared spectroscopy. Importantly, the scope also includes the production of Dxcover’s sample slides for the IVD product.



The Dxcover Liquid Biopsy Platform


Dr David Eustace, Operations Director at Dxcover, said: “This is a major step in the development of any healthcare, diagnostics or medical device company and an essential precursor to launching regulated diagnostic products. Our team has worked exceptionally hard to make sure that we have robust processes in place so that quality is at the heart of the products that we create.


“Earning ISO 13485 shows that we have a well organised quality management system, a solid design control methodology and that the products we take to market will be developed and evaluated to established international standards.”


Dxcover’s certification follows a period of substantial growth for the Glasgow based company. In 2021, Dxcover reached its round two funding target, raising £5.1m in funding to progress its multi-cancer development program.


The firm also took on a 2000 sq ft lab and office space in the University’s Royal College Building in the heart of the Glasgow City Innovation District, home to many of the city’s fastest growing tech and science businesses.


Dr David Eustace, Operations Director at Dxcover.



Dxcover CEO, Mark Hegarty, said: “This award is a great start to 2022. Securing ISO 13485 certification is an important part of our growth ambitions. We have now launched our Series A investment round to fund the pivotal clinical trial for the Dxcover® Brain Cancer test and also to further develop our Dxcover® Cancer, multi-cancer platform. All going to plan there will be further significant expansion of the company this year.”


For more information on Dxcover, please visit www.dxcover.com



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