NEWS
Stroke blood test LVOne gains CE Mark
UpFront Diagnostics has announced it has received CE mark approval for LVOne – the world’s first rapid blood test to diagnose stroke, and the first device of its kind to achieve this certification. The approval enables UpFront to launch the device across the EU and bring advanced diagnostic technology to millions of new patients and providers throughout Europe. This marks the first time a blood test-based stroke diagnostic in vitro diagnosis test device has received CE mark approval. Effective stroke triage requires
portable, affordable tools that operate wherever the patient is, rather than bulky equipment confined to radiology suites. LVOne bridges this gap, extending rapid stroke detection beyond well- resourced specialist centres directly to
emergency teams and paramedics in the field. By shrinking the time between first contact and thrombectomy, LVOne ensures patients reach specialised treatment faster, regardless of location or which ambulance responds. “Nine years ago, we began searching
for stroke biomarkers in a field that had never delivered a patient-ready product,” said Dr Edoardo Gaude, Chief Scientific Officer and Co-founder. “LVOne transforms that research into a certified tool that identifies LVO stroke before a patient reaches hospital. We are excited to launch in Europe, integrating with existing pre-hospital pathways so every patient receives the best available care, wherever their stroke occurs.” LVOne places this capability
directly into the hands of paramedics and emergency teams making split- second decisions in the field. The test uses biomarkers for stroke detection, delivering objective results earlier than traditional assessments. LVOne is also UKCA marked, enabling real-world clinical deployment in the United Kingdom, and is currently being piloted in partnership with the London Ambulance Service. The company holds an ISO 13485:2016 certification for the design, development, manufacturing, and distribution of LVOne.
Cancer diagnostics for real-world care
Researchers have developed a new method that uses real-world evidence from the NHS Man Van pilot – a community cancer testing service – to identify and specify the requirements needed for new diagnostic pathways to work safely and effectively in practice. Promising new cancer diagnostics are
frequently being developed, but many never become part of routine healthcare. While the quality of the science behind a new test drives innovation, translating it into clinical practice is far more complex than demonstrating that the technology works. Researchers from the Cancer Research
UK Convergence Science Centre have developed a new method to help address this challenge. Led by members of the Centre’s Cancer Technology Catalyst Team, the study brought together colleagues from The Institute of Cancer Research, London, The Royal Marsden NHS Foundation Trust and Imperial College London. The findings have been published in Implementation Science Communications. Known as an implementation-aware Target Product Profile (iTPP), the method looks beyond the diagnostic test itself to consider the entire care pathway needed to deliver it safely in practice. Importantly, rather than simply
identifying implementation challenges, the approach uses evidence from patients, clinicians and delivery teams to translate real-world experiences into an auditable, structured set of requirements that can be considered during diagnostic development. The study highlighted several practical
considerations that can affect whether community-based cancer testing works safely and effectively. The research also highlighted the importance of designing services around the realities of delivery. Staffing capacity, patient flow and privacy all need to be considered alongside access. For example, the team found that the physical limitations of mobile testing environments can create challenges for privacy, while visible NHS branding and trusted communication can help build confidence in community setings.
MHRA and Malaysia strengthen partnership on healthcare innovation
The Medicines and Healthcare products Regulatory Agency (MHRA) has reaffirmed its commitment to strengthening regulatory collaboration with Malaysia following high-level discussions in Kuala Lumpur. During the meeting with Malaysia’s
Minister of Health and senior leaders from the country’s healthcare, regulatory and research organisations, MHRA representatives, including Chief Executive Lawrence Tallon, heard about Malaysia’s progress in healthcare, medicines regulation, and research, as well as Minister YB Datuk Seri Dr Dzulkefly Ahmad’s ambition to continue strengthening the country as a leading environment for healthcare innovation, clinical research and life sciences. Discussions focused on opportunities
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WWW.PATHOLOGYINPRACTICE.COM October 2026
to deepen cooperation between the MHRA and Malaysian partners in medicines, medical devices and clinical trials. Areas of potential collaboration include greater expert exchange, sharing regulatory knowledge and best practice, advancing work on emerging technologies, and exploring more efficient development and approval pathways while maintaining high standards of safety, quality, and effectiveness. The meeting forms part of the
MHRA’s wider commitment to strengthening regulatory partnerships with the 11 countries that make up the Association of Southeast Asian Nations (ASEAN), and supporting innovation that delivers benefits for patients around the world.
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