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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/