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US Clinical Trial Results Confirm LVOne Accuracy for Early Stroke Detection

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US Clinical Trial Results Confirm LVOne Accuracy for Early Stroke Detection

We’re excited to share the publication of our latest clinical results in the official journal of the American Stroke Association, Stroke: Vascular and Interventional Neurology. The findings, based on a U.S. clinical trial, validate the accuracy of UpFront Diagnostics’ proprietary blood biomarkers — GFAP and D-dimer — in detecting large vessel occlusion (LVO) stroke patients before they reach the hospital.

Why Early Diagnosis of LVO Matters

Globally, stroke affects more than 20 million people each year. Among these, LVO strokes account for only 30% of cases, but cause up to 95% of related disability and mortality. The key to reducing this burden is a procedure called thrombectomy, which can drastically improve outcomes — but only if performed within hours of symptom onset.

The challenge? LVO strokes are difficult to identify outside a hospital setting, and no tool has proven accurate enough for pre-hospital diagnosis — until now.

The TIME Clinical Study: Validating GFAP and D-dimer

Our TIME clinical study (Testing for Identification Markers of strokE), conducted at Brandon Regional Hospital in Florida, evaluated more than 300 suspected stroke patients from a diverse population. The results demonstrated:

  • 90% accuracy in detecting LVO using GFAP and D-dimer
  • Strong clinical performance in real-world, emergency settings
  • Consistency with previous findings from our UK-based study in collaboration with Newcastle University

These biomarkers are now positioned as the most robust candidates for early detection of LVO stroke in the field.

Transforming Stroke Triage

Deploying this blood test in ambulances could dramatically change how stroke patients are triaged:

  • Faster access to thrombectomy
  • Reduced risk of long-term disability
  • Lower healthcare costs and improved outcomes

This marks a critical step toward delivering precision stroke diagnosis where it matters most — in the pre-hospital setting.

Backed by Leading Institutions

The study involved leading neurologists and neurosurgeons from:

  • Harvard Medical School
  • University of Alabama at Birmingham
  • Duke University School of Medicine
  • Massachusetts General Hospital
  • University of Puerto Rico
  • Brigham and Women’s Hospital
  • UCLA Stroke Center
  • St. Michael’s Hospital (Toronto)
  • SUNY Buffalo’s Jacobs School of Medicine

We’re honoured to collaborate with such outstanding clinical leaders in the advancement of stroke care.

Read the Full Publication

The full peer-reviewed article is available in open-access format:

Read the research in Stroke: Vascular and Interventional Neurology

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