Llusern Scientific Announces ISO 13485 Certification for its Point-of-Care Diagnostics System for Urinary Tract Infections

/EIN News/ -- CARDIFF, United Kingdom, June 17, 2025 (GLOBE NEWSWIRE) -- Llusern Scientific, a point-of-care diagnostics company, announces it has been awarded ISO 13485 certification for its Lodestar DX testing system, a rapid molecular diagnostic platform for urinary tract infections (UTIs). With industry-leading accuracy and speed, Lodestar DX empowers clinicians to diagnose and rule-out infections with precision in a single visit, thereby improving patient outcomes.

Co-founder and CEO, Dr Emma Hayhurst, 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.”

Dr Hayhurst continued, “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 that 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.”

Dr Abdul Ghafur, a leading consultant in infectious diseases in Chennai, India said, “Rapid point-of-care diagnostics will revolutionize the way urinary tract infections are managed worldwide by enabling timely, targeted treatment and reducing the misuse of antibiotics. In the era of rising antimicrobial resistance such innovations are not just helpful, they are essential.”

UTIs represent a massive burden on patients and healthcare systems. There are over 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.

Notes to Editors

About Llusern Scientific

Llusern Scientific is a treatment-directing molecular diagnostics company, developing fast, accurate, and accessible tools to guide real-time clinical decision-making at the point-of-care. Our flagship solution, Lodestar DX, is a portable diagnostic device that delivers lab-accurate results for urinary tract infections (UTIs) in around half an hour. It is based on isothermal LAMP technology (not PCR) without the need for DNA extraction or centralized lab infrastructure. With industry-leading sensitivity and specificity, Lodestar DX empowers clinicians to diagnose and treat specific microbial infections with precision in a single visit, thereby improving patient outcomes. As well as providing guidance on the best treatment option based on the specific microbial infection, Lodestar DX also provides a clear ‘rule-out’ decision where antibiotics are not necessary, helping to reduce antimicrobial resistance through antibiotic stewardship.

Building on success in the UK, Llusern is preparing for commercial launches across India and the MENA region in 2025 and the US in 2026. Llusern is committed to transforming diagnostic pathways and making precision medicine equitable, portable, and fast. Due to its small size and ease of portability Lodestar DX is particularly suitable for resource limited and decentralised healthcare settings including care homes, mobile diagnostics, and community diagnostic centres. Additionally Lodestar DX has uses within paediatrics, urology, and other secondary care settings.

The Lodestar DX UTI testing system has been independently evaluated in studies by University of Oxford, Norfolk and Norwich University Hospital, Southampton University, and Public Health Wales. The company was established in 2020 as a spin-out from the University of South Wales, UK.

For more information, visit https://llusern.co.uk/ and follow us on LinkedIn.

Media Contacts

Llusern Scientific
Martyn Lewis +44 (0) 7825 708936
martyn@llusern.co.uk

Scius Communications

Katja Stout +44 (0) 7789435990
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Daniel Gooch +44 (0) 7747875479
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