BSTE Biosite (MM)

Biosite(R) Incorporated Announces Development Strategy for MPO SAN DIEGO, June 22 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated (NASDAQ:BSTE) today announced it is developing a second generation Triage(R) Cardio ProfilER(TM) Panel that will include myeloperoxidase (MPO), a marker of inflammation in the walls of coronary arteries. The Company believes the addition of MPO can advance the diagnostic utility of the product, which is used for emergency assessment of chest pain patients. The Triage Cardio ProfilER Panel currently measures the levels of troponin I, 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 acute coronary syndromes (ACS). The Company is targeting to commence clinical trials for the Triage Cardio ProfilER Panel that will include MPO in the third quarter of 2005. Pending the completion of clinical trials for the product, the Company anticipates filing a Premarket 510(k) Notification with the United States Food and Drug Administration (FDA) by the fourth quarter of 2005. "Adding MPO to the Triage Cardio ProfilER Panel would represent another step toward better chest pain evaluation," said Kim Blickenstaff, Biosite chairman and chief executive officer. "Chest pain is a primary reason for visits to emergency departments, worldwide, yet many patients ultimately go undiagnosed. We are encouraged by research and ongoing clinical studies that suggest the use of multi-marker panels can significantly improve assessment of chest pain, potentially leading to better patient outcomes and emergency department efficiencies." Research conducted at The Cleveland Clinic by Stanley Hazen, M.D., Ph.D., head of the Section of Preventive Cardiology, showed that an elevated MPO level could signal a person's risk for heart disease or heart attack. According to results published October 23, 2003 in the New England Journal of Medicine, researchers found that among the one-quarter of patients studied with the highest MPO levels, 38.4 percent had a heart attack within 16 hours, compared with 13.9 percent of those with MPO levels in the lowest quartile. The highest levels also were associated with much higher rates of death, heart attack and major heart procedures at both 30 days and six months later, researchers reported. The diagnosis of ACS by conventional assessment in an emergency department (ED) has long been a source of uncertainty and error. More than 110 million patient visits to EDs occur in the United States annually, of which an estimated 10 million are related to complaints of chest pain or similar symptoms that suggest potential acute cardiac ischemia(1). Almost two thirds of patients with chest pain are admitted but only 13 to 15 percent are ultimately diagnosed with heart attack. Traditional assessment has also resulted in a high rate of "missed" heart attacks: of the 40 percent of patients with chest pain who are discharged from the ED, one to five percent actually have a heart attack(2). These diagnostic errors are costly, with estimates for the rule-in process reaching at least $600 million per year in unnecessary inpatient expenses(3). Additionally, for primary care and ED physicians, misdiagnosis of heart attack is the leading cause of malpractice litigation and unneeded hospitalization. To distinguish potential heart attacks from other diseases or conditions, doctors currently rely on EKG and stress tests as well as clinical assessments of patients' medical history and origin of pain. Increasingly, physicians utilize blood tests for evidence of enzymes and proteins released into the bloodstream when heart muscle cells are in distress or dying, which provide strong evidence that a patient is having a heart attack. Biosite announced in February 2004 that it had obtained exclusive diagnostic rights for point-of-care testing and semi-exclusive diagnostic rights for automated testing of MPO from The Cleveland Clinic. 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 benefits of a MPO test, the Company's ability to complete clinical trials that will support regulatory submissions for a MPO test and the Company's ability to achieve regulatory clearance for a MPO test. Risks and uncertainties include risks that planned clinical trials will not commence when expected, risks that the Company will experience delays in the completion of such clinical trials, 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. (1) McCaig LF, Burt CW. National Hospital Ambulatory Medical Care Survey: 2002 Emergency Department Summary. Advance data from vital and health statistics; no 340. Hyattsville, Maryland: National Center for Health Statistics. 2004. (2) Ornato JP. Chest Pain Emergency Centers: Improving Acute Myocardial Infarction Care. Clin. Cardiol. 22, (Suppl. IV), IV-3-IV-9 (1999) (3) Jesse RL, Kontos MC: Evaluation of chest pain in the emergency department. Curr Probl Cardiol 1997; 22:149-236 DATASOURCE: Biosite Incorporated CONTACT: Nadine Padilla, VP, Corporate & Investor Relations of Biosite Incorporated, +1-858-455-4808, ext. 3187, Web site: http://www.biosite.com/

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