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Stroke is a medical emergency resulting from a disruption of the blood supply to the brain due to either blood vessel blockage (ischemia) or rupture (hemorrhage). The vast majority (>85%) of strokes are ischemic in nature. Rapid and accurate diagnosis of whether a stroke is caused by ischemia or by a ruptured blood vessel is critical to determining the optimal treatment plan and preventing further irreversible tissue damage or even death. Currently there are no quick and simple approved commercial methods to do this, and physicians rely upon neurological assessment and various imaging techniques such as CT and MRI to diagnose the type of stroke and rule out a hemorrhagic event. Thrombolytic therapy using intravenous administration of recombinant tissue plasminogen activator (rtPA) is a proven and effective treatment of acute ischemic stroke. However, rtPA treatment must be given quickly, within 3 hours and maximally 4.5 hours, from the onset of symptoms of stroke.

Stroke Brain Damage Assay

Through a long-standing partnership with a team led by Dr. Jean-Charles Sanchez at the University of Geneva, Proteome Sciences has identified six key biomarkers that

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have been shown to correlate with stroke having occurred and which are detectable within 15 minutes of the infarct or haemorrhage occuring. The Stroke Brain Damage Assays identify markers of brain damage from patient serum or plasma samples using a simple and highly sensitive ELISA immunoassay format with chemiluminescent detection chemistry. The assays can be completed well within the critical 3 hour time window from onset of ischemic stroke symptoms required for safe and effective treatment with rtPA. 

Using a specially collected prospective cohort of ischaemic and haemorrhagic stroke patients and appropriate controls we have defined an optimum panel of plasma markers for the rule-in of ischaemic stroke in the Emergency Room and a slightly different panel for the rule-out of any stroke in the Primary Care setting. Both tests have around 90% sensitivity and specificity meaning 9 out of 10 patients can be correctly categorized in each case.

Proteome Sciences and the University of Geneva hold several issued and pending patents relating to stroke biomarkers and their use in clinical practice.

Protein Biomarker	Sensitivity/LOD
H-FABP	Low ng/ml
B-FABP	Low ng/ml
GST-P	Low ng/ml
NDKA	Low ng/ml
UFD1	Low ng/ml

References