Cerebrovascular Diseases

According to the American Heart Association (AHA), stroke is the third leading cause of death in the United States, resulting in 275,000 deaths annually, and is a leading cause of adult disability. The AHA estimates that in 2005, the direct and indirect costs associated with stroke in the United States will exceed $56 billion.

With symptoms such as unexplained, sudden numbness or weakness, confusion, dizziness and trouble walking and talking, stroke is often mistaken for other illnesses and conditions that have similar clinical presentations. Existing methods to diagnose stroke and confirm symptoms utilize radiographic imaging, such as computed tomography (CT scan), which are subject to interpretation and often unable to detect the most common form of stroke until 12 to 24 hours after an event.

Biosite^® Incorporated has identified and investigated numerous biomarkers that appear to be related to stroke. Using thousands of clinically defined patient samples provided by leading medical centers worldwide we validated multiple markers that are highly correlated to stroke and initiated product development activities on a diagnostic device in 2001 and clinical studies in 2004. The device will be used as an aid in the assessment and diagnosis of cerebral ischemia (stroke). We filed a premarket approval application for the Triage^® Stroke Panel with the U.S. Food and Drug Administration at the end of 2004. The Triage Stroke Panel will be made available for sale outside the U.S. in the first half of 2005, subject to obtaining any required foreign regulatory clearances.