SAN DIEGO, Feb. 21 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE), a research-based provider of novel, rapid medical diagnostics,
today announced the U.S. Food and Drug Administration (FDA) has notified the
Company that the agency has accepted the Triage(R) Stroke Panel Premarket
Approval Application (PMA) for further review. The panel is intended to be
used as an aid in the assessment and diagnosis of cerebral ischemia (stroke).
The Triage Stroke Panel consists of multiple biomarkers and utilizes a
proprietary algorithm to calculate a single MultiMarker Index(TM) result.
"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. Information on Biosite can be found at
http://www.biosite.com.
Except for the historical information presented herein, matters discussed
in this press release are forward-looking statements that involve risks and
uncertainties that could cause actual results to differ materially from any
future results, performance or achievements expressed or implied by such
statements. Statements that are not historical facts, including but not
limited to statements that are preceded by, followed by, or that include the
words "will"; "believes"; "should"; "intends"; "anticipates"; "plans";
"expects"; "estimates"; or similar statements are forward-looking statements.
Forward looking statements include statements about the potential benefits of
the Triage Stroke Panel. Risks and uncertainties include risks regarding the
discovery and product development process generally, risks that the FDA may
request additional information or data regarding the Triage Stroke Panel,
risks that the product may not receive FDA approval or that such approval may
be delayed or limited, risks associated with the commencement of manufacturing
the Triage Stroke Panel on a commercial scale, and risks that the Triage
Stroke Panel may not be commercially successful. Other risks and
uncertainties that may impact the Company's business generally include risks
associated with the introduction of competitive products from companies with
greater capital and resources, expansion or development of a direct sales
effort in domestic and international markets, and risks and expenses
associated with litigation, contract disputes, patent conflicts, product
recalls, manufacturing constraints, backlog, delays or inefficiencies,
shipment problems, seasonal customer demand, the timing of significant orders,
changes in reimbursement policies, regulatory changes, competitive pressures
on average selling prices, and the other risks including those detailed in the
Company's most recent Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and other SEC filings. The Company disclaims, however, any intent or
obligation to update these forward-looking statements. Copies of the
Company's public disclosure filings are available from the Investor Relations
department.
Biosite(R), Triage(R) and New Dimensions in Diagnosis(R) are registered
trademarks of Biosite Incorporated. The Company's logo is a trademark of
Biosite Incorporated. MultiMarker Index(TM) is a trademark of Biosite
Incorporated.
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com
Company News On-Call:
http://www.prnewswire.com/comp/116737.html
CONTACT:
Nadine Padilla, VP, Corporate & Investor
Relations of Biosite Incorporated, +1-858-455-4808, ext. 3187,
npadilla@biosite.com
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