Stroke is the leading cause of disability and the third leading cause of death in the U.S., with an estimated $60 billion negative impact upon the economy in indirect and direct costs in 2006. Immediate treatment of stroke is critical for preservation brain tissue and ultimate recovery. For ischemic stroke, which comprises approximately four-fifths of all strokes, thrombolytic therapy by tissue plasminogen activator (tPA) has been proven to be effective in the critical first 3 hours from symptom onset. Unfortunately, studies have shown symptomatic hemorrhagic occurs in 6-11% of patients treated with intravenous tPA. Fear of this severe and often deadly side effect prevents the widespread use and full benefit of this therapy in the ischemic stroke population. This SBIR Phase II application proposes the development of a point-of-care rapid diagnostic test for the proteomic marker cellular fibronectin (c-Fn), which has been shown in 3 independent studies to predict hemorrhagic transformation in tPA-treated patients with a sensitivity of 100%, as an aid to treatment decision. The goal under this proposal is to create a rapid test for c-Fn based on lateral flow technology with the ability to obtain a result within 10 minutes, achieve inter- and intra-assay variability of <10%, and achieve a total production cost of under $25.
Project Narrative Physicians must decide on treatment of an ischemic stroke patient with a clot buster, tPA, within a critical 3 hour time window. The amount of cellular fibronectin (c-Fn) in the blood of patients at admission can identify if the patient is at high or low risk for a subsequent hemorrhage, fear of which prevents widespread useage of tPA. This proposal develops a rapid c-Fn test completed in 10 minutes to aid in the treatment decision of acute ischemic stroke patients that would lead to increase in patient safety, decrease in the long-term disability of stroke, and lower long-term healthcare spending.