Biosite(R) Incorporated Announces Development Strategy for MPO
June 22 2005 - 8:01AM
PR Newswire (US)
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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