Abstract

Circulating Cells and Extracellular Vesicles as a Source of mRNA for the In Vitro Diagnostics of Acute Ischemic and Hemorrhagic Strokes

Steve Soper, Foundation Distinguished Professor; Director, Center of BioModular Multi-scale System for Precision Medicine, Adjunct Professor, Ulsan National Institute of Science & Technology, The University of Kansas

Stroke is the third leading killer in the US and the main cause of over 795,000 cases of adult disability each year. The two major types of stroke, ischemic and hemorrhagic, cannot be clinically differentiated; 30% of patients presenting stroke-like symptoms do not have stroke and <5% of stroke patients are treated with available therapeutics (recombinant tissue plasminogen activator for acute ischemic stroke). Computed tomography is commonly used for diagnosis, which provides a clinical sensitivity of only 25%, and in most cases, does not provide clinical information to meet the necessary time requirements for proper therapeutic administration (<4.5 h). Unfortunately, there are no FDA-approved in vitro diagnostic tests for stroke that could address the aforementioned issues. In this presentation, we will provide data on the use of liquid biopsy markers, in particular circulating extracellular vesicles (EVs – CD8 and CD15 expressing EVs) as a source of mRNA to diagnose ischemic and hemorrhagic stroke. Isolation technologies used for the timely enrichment of the appropriate liquid biopsy markers along with rapid reporting molecular assays of mRNA expression will be presented that provide clinical information to assess the status of the patient in terms of a stroke mimic or ischemic/hemorrhagic stroke in a timely manner. Appropriate mRNA gene panels will be presented that provide high clinical sensitivity and specificity for the in vitro diagnostic assay.