UpFront Diagnostics has announced CE marking for LVOne, a rapid blood-based test designed to support the identification of severe stroke before patients reach hospital. The Cambridge-based company describes LVOne as the first rapid blood test for stroke to achieve CE certification, enabling its commercial launch across the European Union.
LVOne is intended primarily to help identify large vessel occlusion (LVO), a form of ischaemic stroke in which rapid access to mechanical thrombectomy can be critical. The point-of-care test uses a finger-prick blood sample and measures D-dimer and glial fibrillary acidic protein (GFAP), biomarkers associated with clot formation and intracerebral haemorrhage respectively. Results are available within 10 minutes.
The technology is designed for use by paramedics and other emergency teams, potentially allowing patients suspected of having an LVO to be identified earlier and transported to an appropriate specialist stroke centre.
A 2026 study involving samples from 210 patients with suspected stroke reported 75% sensitivity, 92% specificity and a 97% negative predictive value for LVO detection using LVOne alongside clinical assessment. An updated version also demonstrated improved identification of intracerebral haemorrhage. The researchers noted that prospective validation in real-world pre-hospital settings remains necessary.
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LVOne had previously received UKCA marking and is being deployed with the London Ambulance Service. The company says the CE mark will now allow the technology to be introduced more widely in European stroke pathways.
Gonzalo Ladreda, CEO and co-founder of UpFront Diagnostics, said the regulatory milestone would help accelerate the company’s aim of reducing delays in stroke diagnosis.
The CE marking represents a further step towards incorporating biomarker-based testing into pre-hospital stroke triage, where rapid identification of patients requiring specialist intervention could help shorten the time to definitive treatment.
This news item has been summarised using AI and checked by humans before publication.
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