Biosite Announces U.S. 510(k) Filing for MPO Tests
04 January 2006 - 12:00AM
PR Newswire (US)
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. DATASOURCE: Biosite Incorporated CONTACT: Nadine
Padilla, VP, Corporate & Investor Relations of Biosite
Incorporated, +1-858-805-2820, Web site: http://www.biosite.com/
Company News On-Call: http://www.prnewswire.com/comp/116737.html
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