Breakthrough for UK diagnostics startup could speed its journey towards clinical trials and beyond.
Diagnostics startup Glyconics has developed a novel approach to the diagnosis and monitoring of diseases, such as diabetes and COPD.
The device uses infrared light to produce a distinctive molecular ‘fingerprint’ in healthy vs non-healthy samples using a predictive algorithm in point-of-care devices.
Having launched in 2013, the firm has just been awarded an internationally recognised quality certification for the design and development of its medical devices.
The move, the company tells HT World, will enable it to embark on its next funding round and it is now seeking new partnerships as it focuses on finalising its devices before proceeding into clinical validation trials.
Following a review by BSI, Glyconics has been awarded ‘ISO 13485:2016’ and ‘EN ISO 13485:2016’ certification for its quality management system.
The scope of the ISO certification includes the “design and development of medical devices for the diagnosis and monitoring of chronic obstructive pulmonary disease (COPD), and the screening of diabetes mellitus”.
It is “fundamentally important” to the company’s development, which is backed by venture capitalist firms Deepbridge Capital and Boundary Capital along with three angel investors.
It is now seeking new partnerships in addition to its collaborations with sample analysis firm Spectrolytic, Ghent University, NHS Portsmouth University Hospital and Wessex Academic Health Science Network (AHSN).
CEO Dr Kam Pooni tells HT World: “This is a fundamentally important milestone for the business because it is formal recognition that we are developing products which are safe and effective for patients and clinicians.
“ISO 13485:2016 is a recognised quality mark in Europe, which also indicates standards that are equally important in all global markets.
“Securing this certification is a basic foundation that is essential for our product commercialisation, which can now proceed into clinical validation and production as soon as the devices are finalised.
“Our lead product ranges in development are the ones for Diabetes and COPD, and we can the extend the certificate to any products we develop at Glyconics.”
The company has also been awarded an EU Seal of Excellence certificate for its miniaturised IR spectroscopy technology that previously could only be undertaken by highly trained staff in a laboratory.
Pooni says: “Our IR spectroscopy technology platform offers many advantages. It is non-invasive, accurate without the need for sample preparation and it provides immediate results at point of care.
“We are supporters of patient involvement and advocating patient self-care and self-monitoring, and we are pioneers of a new generation of diagnostics that can identify disease biomarkers in minutes at point-of-care and enable patients and physicians to work together in monitoring disease progression.”
Healthcare delivery is moving increasingly towards decentralised settings such as rapid clinics and the home, driven by point-of-care diagnostics.
As part of the certification process, Glyconics participated in an independent audit, despite the challenges and restrictions imposed by the current pandemic.
Pooni adds: “With the support of our board and our investors, we started the process with BSI two years ago, and it has been extremely valuable and especially important to our credibility to have that quality assurance independently assessed in such a transparent way.
“I believe that quality is a competitive advantage – and, looking to the future, this puts Glyconics in absolutely the best position to grow and make a global impact.”
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