TRIAGE STROKE PANEL PMA ACCEPTED FOR FDA REVIEW.
"This is an important first step in the regulatory process and we look forward to working with the FDA on next steps," said Kim Blickenstaff, Biosite's chairman and chief executive officer.
Biosite submitted its PMA for the Triage Stroke Panel in December of 2004. The acceptance of the application reflects a threshold determination by the FDA that the PMA is sufficiently complete to permit a substantive review. It does not imply that a decision about the approvability of the application has been made.
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. According to estimates from the Centers for Disease Control and Prevention, there are more than 8 million emergency department visits annually by patients with symptoms that could indicate stroke. Of these 1.2 million are ultimately diagnosed with stroke. The American Heart Association estimates that in 2005, the direct and indirect costs associated with stroke in the United States will exceed $56 billion.
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. Currently in the United States, there is no rapid, in-vitro diagnostic test utilizing protein markers from a blood sample commercially available for use as an aid in the diagnosis of stroke.
About Biosite Incorporated
A leader in the drive to advance diagnosis, Biosite Incorporated is a research-based company dedicated to the discovery and development of novel protein-based diagnostics that improve a physician's ability to diagnose debilitating and life-threatening diseases. Through combined expertise in diagnostic discovery and commercialization, Biosite is able to access potential markers of disease, identify proteins with high diagnostic utility, develop and commercialize products and educate the medical community on new diagnostic approaches, thereby benefiting patients. Biosite's Triage(R) rapid diagnostics are used in approximately 50 percent of U.S. hospitals and in more than 50 international markets for toxicology screening and diagnosis of infectious and cardiovascular disease.
For more information, visit http://www.biosite.com or call 858/455-4808, ext. 3187.
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|Date:||Apr 1, 2004|
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