Llusern Scientific Speeding Up Infection Diagnosis with Welsh Innovation Support
With targeted support from the Welsh Government's Innovation team, the company, which is based at Cardiff Edge Business Park, is bringing its first product to market. It is set to pave the way for faster diagnosis, better patient outcomes and reduced antibiotic misuse.
Established in 2020 as a spin-out from the University of South Wales, the company set out to address a major health challenge. Urinary infections affect more than 100 million people worldwide each year. Its portable, easy-to-use molecular diagnostic device delivers accurate results within 35 minutes, giving clinicians fast and reliable information.
The company has now announced that it has been awarded ISO 13485 certification for its Lodestar DX testing system, a rapid molecular diagnostic platform for urinary tract infections (UTIs).
Dr Emma Hayhurst, co-founder and CEO of Llusern Scientific, said:
'When we founded Llusern Scientific, we were on a mission to make a positive difference in healthcare by developing a point-of-care diagnostic that would enable us to improve antimicrobial stewardship. Achieving ISO 13485 certification is a major milestone in our mission because it demonstrates that we have built a manufacturing facility to world-class standards.
'Not only does our Lodestar UTI testing system help a clinician decide whether or not to prescribe an antibiotic, but it will also identify the bacterial cause of the UTI. This enables clinicians to quickly target the right bug with the right treatment to save lives. Now we have ISO 13485 certification, our next goal is to achieve IVDR certification to further expand the market potential for our innovative molecular diagnostic globally.'
There are more than 400 million UTI cases globally each year, of which around 90% are women. According to the Sepsis Trust approximately 15-30% of sepsis cases are caused by a UTI. Research has shown that antibiotics are overprescribed by as much as two times for UTIs leading to them being a major driver of antimicrobial resistance (AMR). As well as providing guidance on the best treatment option, Lodestar DX also provides a clear 'rule-out' decision where antibiotics are not necessary, helping to reduce AMR through antibiotic stewardship.
ISO 13485 certification is a crucial regulatory step for marketing medical devices globally, as it demonstrates that a manufacturer has a robust Quality Management System in place, showing commitment to patient safety, regulatory compliance, and consistent product quality.
Llusern is preparing for commercial launches across India and the Middle East and North Africa region this year, and the US in 2026.
The company has received a range of targeted support from the Welsh Government's Innovation team, including SMART Flexible Innovation Support (SFIS), expert design assistance and intellectual property (IP) strategy development—each playing a vital role in advancing the technology and preparing for commercial scale-up.
Initial SFIS support in early 2024 enabled the team to develop a clear innovation plan, setting out priorities for product improvements, new clinical applications and growth. A second SFIS award in September 2024 has since supported the delivery of this plan, while design and IP interventions have strengthened its route to market.
As a result, Welsh Government innovation support has helped Llusern Scientific to: Enhance its existing diagnostic platform, making it suitable for use in a wider range of clinical settings.
Develop a new unique test panel design, addressing contamination risks and improving ease of use for non-laboratory settings.
Strengthen its IP portfolio through a comprehensive audit and actionable recommendations, boosting investor confidence.
Expand research and development facilities at Cardiff Edge Business Park.
Advance collaborations with Public Health Wales and NHS partners, supporting clinical validation and real-world evidence generation.
While Agile Cymru funding has provided valuable opportunities to explore international markets, the company's core innovation progress has been driven by targeted support from the Welsh Government's Innovation team.
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