First-of-Its-Kind Rapid Blood Test Gains CE Mark to Support Prehospital Stroke Triage

However, definitive assessment typically requires hospital-based imaging, which can complicate triage for emergency teams. Portable blood-based testing could provide objective information at the point of care to guide referrals and shorten time to thrombectomy. To support earlier triage, a newly approved device brings stroke biomarker testing to paramedics and other first responders.

UpFront Diagnostics’ (Cambridge, UK) LVOne is described as the world’s first rapid blood test to diagnose stroke and the first device of its kind to receive CE mark approval. The company announced the certification in Cambridge, United Kingdom, on September 7, 2026, noting that the approval confirms compliance with European Union safety, health, and environmental standards. The certification enables launch of the device across Europe. This represents the first CE-marked, blood test-based in vitro diagnostic for stroke.

LVOne uses blood-based biomarkers to detect stroke and identify large vessel occlusion before hospital arrival, providing objective results earlier than traditional assessments. Designed for use by emergency medical services, the system extends rapid detection beyond radiology suites to the field. The approach is intended to shorten the interval from first contact to thrombectomy by supporting triage and transport decisions.

In addition to CE marking, LVOne holds United Kingdom Conformity Assessed (UKCA) marking to support real-world clinical deployment in the U.K. The test is currently being piloted with the London Ambulance Service. UpFront Diagnostics also reports certification to ISO 13485:2016 for the design, development, manufacturing, and distribution of LVOne.

“Stroke is a leading cause of death worldwide. 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,” said Gonzalo Ladreda, CEO and Co-founder of UpFront Diagnostics.

“Nine years ago, we began searching for stroke biomarkers in a field that had never delivered a patient-ready product. 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,” said Dr. Edoardo Gaude, Chief Scientific Officer and Co-founder.

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