UpFront Diagnostics Receives CE Mark for Rapid Stroke Blood Test LVOne
News related to:UpFront Diagnostics · 2 min read
CAMBRIDGE, United Kingdom, Sept. 16, 2026 /CourierPR/ -- UpFront Diagnostics has achieved a significant regulatory milestone with the CE mark approval for its innovative LVOne blood test, the world's first rapid diagnostic tool for stroke. This certification allows the company to launch the device across Europe, bringing advanced stroke detection technology to millions of patients and healthcare providers.
The LVOne test is designed to identify large vessel occlusion (LVO) strokes, a critical type of stroke that requires immediate treatment. By providing objective results faster than traditional assessments, the test enables emergency teams and paramedics to make quicker decisions, reducing the time between the first contact and thrombectomy, a procedure that can significantly improve patient outcomes.
The approval of the CE mark confirms that the LVOne test meets all EU safety, health, and environmental standards. This certification is a crucial step in making the device available to acute and emergency care providers across Europe, ensuring that patients receive the best possible care, regardless of their location.
Dr. Edoardo Gaude, Chief Scientific Officer and co-founder of UpFront Diagnostics, added, "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 the hospital."
The LVOne test places diagnostic capabilities directly into the hands of paramedics and emergency teams, making it a portable and affordable tool for rapid stroke detection. This innovation is particularly important for extending stroke detection beyond well-resourced specialist centers to the field, where immediate action can be critical.
UpFront Diagnostics, founded in Cambridge in 2017, is a medtech company focused on developing and commercializing rapid point-of-care diagnostic tests for time-critical medical conditions. The company's flagship product, LVOne, uses innovative biomarkers to support the early identification of severe stroke. The device is currently being piloted in partnership with the London Ambulance Service and is UKCA marked, enabling real-world clinical deployment in the United Kingdom.
The approval of the CE mark is a significant regulatory milestone that accelerates UpFront Diagnostics' mission to improve stroke care across Europe. The company is now poised to enter a phase of rapid growth, integrating the LVOne test into existing pre-hospital pathways to ensure that every patient receives the best available care, wherever their stroke occurs.