Healthcare Industry News: Acute Coronary Syndrome
News Release - January 3, 2006
Biosite Announces U.S. 510(k) Filing for MPO TestsSAN DIEGO, Jan. 3 (HSMN NewsFeed) -- Biosite® 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® 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® 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 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®, Triage® and New Dimensions in Diagnosis® 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.
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