UpFront Diagnostics secures CE mark for LVOne rapid blood test for stroke
UpFront Diagnostics has secured CE mark approval for LVOne, a rapid blood test designed to identify large-vessel-occlusion stroke in pre-hospital settings.
LVOne is intended to support faster triage of suspected stroke patients by identifying biomarkers associated with large-vessel occlusion from a blood sample before hospital arrival.
The CE mark enables European commercialisation and could support more rapid routing of eligible patients to specialist stroke centres for thrombectomy assessment.
Field | Content |
Alert Type | Approval |
Product Name | LVOne |
Company | UpFront Diagnostics |
Regulatory Authority | European CE marking framework |
Approval Type | CE mark approval |
Intended Use | Rapid blood-based identification of large-vessel-occlusion stroke in suspected stroke patients |
Therapy Area(s) | Neurology; stroke; diagnostics |
Technology or Modality | In-vitro diagnostic blood test |
Geography | Europe |
What Happened | UpFront Diagnostics secured CE mark approval for LVOne, enabling commercialisation of the rapid blood test in Europe. |
Why It Matters | Large-vessel-occlusion stroke requires rapid specialist intervention, and an earlier blood-based indication could support faster patient triage and transfer decisions. |
Supporting Context | LVOne is designed for use close to the patient, including pre-hospital settings, to help identify patients who may need assessment for mechanical thrombectomy. |
Key Takeaway | LVOne has received CE mark approval, opening a European commercial pathway for rapid blood-based stroke triage. |
What to Watch | Commercial rollout, adoption by emergency medical services and real-world evidence showing whether LVOne shortens time to specialist stroke treatment. |
Primary Source | UpFront Diagnostics |
Relevant Date | 16 September 2026 |
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