SAN DIEGO, Jan. 3 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE), announced today that the Company has submitted a 510(k)
Premarket Notification with the U.S. Food and Drug Administration for
diagnostic tests for myeloperoxidase (MPO), a biomarker of inflammation in the
walls of coronary arteries. MPO appears to be an indicator of unstable
atherosclerotic plaque, and has been shown to elevate earlier than current
markers of cell death(i). The Company licensed certain diagnostic rights to
MPO in 2004 under an agreement with The Cleveland Clinic Foundation and
Prognostix, Inc.
MPO is believed to be useful as an aid in the early diagnosis of
myocardial infarction and could signal risk for heart disease or heart attack
in patients with chest pain or acute coronary syndromes (ACS)(i). Biosite
plans to offer a single Triage(R) MPO Test and a second generation Triage
Cardio ProfilER(TM) Panel that will include MPO.
The Company believes the addition of MPO to the Triage Cardio ProfilER
Panel can advance the diagnostic and prognostic utility of the product, which
is used for emergency assessment of chest pain patients. The panel currently
measures the levels of troponin and its complexes, along with CK-MB, BNP and
myoglobin in blood and is used as an aid in the diagnosis of myocardial
infarction (heart attack), diagnosis and assessment of severity of congestive
heart failure and risk stratification of patients with ACS.
About Biosite Incorporated
Biosite Incorporated is a leading bio-medical company commercializing
proteomics discoveries for the advancement of medical diagnosis. The
Company's products contribute to improvements in medical care by aiding
physicians in the diagnosis of critical diseases and health conditions.
Biosite's Triage(R) rapid diagnostics are used in approximately 50 percent of
U.S. hospitals and in over 50 international markets. 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 market need for a
rapid MPO test, whether individually or as part of a panel of tests, the
potential utility of a MPO test and the Company's ability to achieve
regulatory clearance for a MPO test. Risks and uncertainties include, risks
that regulatory approvals for a MPO test will be delayed or rejected, risks
associated with manufacturing the MPO products on a commercial scale and
uncertainties related to the market acceptance and sales execution of a MPO
test. Other risks and uncertainties that may impact the Company's business
generally include risks associated with the discovery and product development
process generally, 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, as amended, 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.
(i) Brennan, ML, Ph.D., Penn, MS, M.D., Ph.D., et al. Prognostic Value
of Myeloperoxidase in Patients with Chest Pain. N Engl J Med 2003;
349:1595-604.
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, +1-858-805-2820,
npadilla@biosite.com
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