Cambridge, United Kingdom, 7th September 2026: UpFront Diagnostics has announced 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 confirms that LVOne meets all EU safety, health, and environmental standards, enabling UpFront to launch the device across the region 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 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.
“Stroke is a leading cause of death worldwide,” said Gonzalo Ladreda, CEO and Co-founder of UpFront Diagnostics. “The LVOne test democratises access to early stroke diagnosis, and securing CE mark approval marks a major regulatory milestone that accelerates our mission to reduce diagnostic times. We invite acute and emergency care providers across the EU to take advantage of this development as we enter a phase of rapid growth.”
“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.”
Instead of confining point-of-care diagnostics to labs or hospitals, LVOne places this capability directly into the hands of paramedics and emergency teams making split-second decisions in the field. The goal is simple: shorten the time from first contact to thrombectomy, ensuring patients reach specialised treatment faster, regardless of location. It uses biomarkers for stroke detection, delivering objective results earlier than traditional assessments.
LVOne, is 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.
