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US clinical trials

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Each year, over 20 million people worldwide suffer from strokes. Large vessel occlusions (LVO), which constitute 30% of all strokes, account for a staggering 95% of stroke-related disabilities and fatalities. The likelihood of recovery significantly increases if a treatment called ‘thrombectomy’ is administered within hours of the initial symptoms.

However, swiftly administering treatment is complicated because LVO patients are difficult to diagnose outside of hospital settings due to the overlap of stroke symptoms with other medical conditions. Additionally, strokes can result from small blood vessel blockages or bleeding, which are not treatable with thrombectomy.

Early diagnosis of LVO strokes, ideally before reaching the hospital, could expedite thrombectomy treatment. Currently, there is no tool with sufficient accuracy for such early detection.

The TIME (Testing for Identification Markers of strokE) clinical study, conducted at Brandon Regional Hospital in Florida, has validated Upfront’s proprietary blood biomarkers, GFAP and D-dimer, demonstrating 90% accuracy in detecting LVO patients. This study involved over 300 suspected stroke patients from a highly diverse ethnic background.

These impressive results reinforce findings from an earlier clinical study by Upfront Diagnostics in collaboration with Newcastle University in the UK. They pave the way for the identification of LVO patients before hospital admission. Implementing these blood biomarkers in the field could significantly expedite thrombectomy treatment, potentially reducing the risk of disability by half and lowering the overall healthcare and societal costs of stroke. Consequently, Upfront is positioning GFAP and D-dimer as leading candidates for pre-hospital LVO patient identification.

Several esteemed doctors from various American neurology and neurosurgery departments participated in the study, including those from Harvard Medical School, University of Alabama at Birmingham, Duke University School of Medicine, University of Puerto Rico School of Medicine, Massachusetts General Hospital, Brigham and Women’s Hospital, St. Michael’s Hospital in Toronto, UCLA Stroke Center, and SUNY Buffalo’s Jacobs School of Medicine.

The study’s findings have been published in an open-access article in “Stroke: Vascular and Interventional Neurology,” an official journal of the American Stroke Association, a division of the American Heart Association, and the Society of Vascular and Interventional Neurology.

Read the complete research article here.

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