New Test Aids Emergency Physicians in Diagnosing Highly Lethal Conditions
SAN DIEGO, Feb. 16 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE), a research-based provider of novel, rapid medical diagnostics,
today announced the U.S. launch of its new, rapid, quantitative Triage(R)
D-Dimer Test. The Triage D-Dimer Test aids in the assessment and evaluation
of patients suspected of having thromboembolic events, including pulmonary
embolism (PE) and deep vein thrombosis (DVT), which are common and potentially
lethal conditions.
Portable and easy-to-use, this point-of-care diagnostic test provides
D-dimer results in approximately 15 minutes and can be used in the emergency
department or at a patient's bedside. The test uses highly sensitive
immunoassay technology and the highly specific 3B6 D-dimer antibody(1)(2)(3).
The Triage D-Dimer Test is run on the widely used Triage MeterPlus and
correlates with other ELISA-based D-dimer tests.
"Pulmonary embolism is a time-critical and potentially life threatening
condition. Because patients often present with vague symptoms, PE represents
a clinical and diagnostic challenge," said Ken Buechler, Ph.D., Biosite's
president and chief scientific officer. "We believe the Triage D-Dimer Test,
used at the point-of-care, can help emergency department physicians rapidly
evaluate patients suspected of having a thromboembolic event, which should
result in better patient care."
In a recent single center study published in the Annals of Emergency
Medicine, a point-of-care clinical protocol for the evaluation of PE using a
commercially available rapid whole-blood immunochromatographic test for
D-dimer doubled the number of patients evaluated for PE and decreased length
of stay in the emergency department, without increasing the need for vascular
imaging(4).
Currently, more cases of PE are missed than are actually diagnosed because
of vague and non-specific symptoms. PE is the third most common cause of
death in the United States, with at least 650,000 cases occurring annually.
It is the first or second most common cause of unexpected death in most age
groups. The highest incidence of recognized PE occurs in hospitalized
patients. Autopsy results show as many as 60 percent of patients dying in the
hospital have had a PE, but the diagnosis has been missed in about 70 percent
of the cases(5).
In November 2003, Biosite signed an agreement with Brisbane-based
biotechnology company Agenix Limited (ASX: AGX) for a license to D-dimer
technology and the commercial supply of the 3B6 D-dimer antibody.
About Biosite Incorporated
A leader in the drive to advance diagnosis, Biosite Incorporated is a
research-based company dedicated to the discovery and development of novel
protein-based diagnostics that improve a physician's ability to diagnose
debilitating and life-threatening diseases. Through combined expertise in
diagnostic discovery and commercialization, Biosite is able to access
potential markers of disease, identify proteins with high diagnostic utility,
develop and commercialize products and educate the medical community on new
diagnostic approaches, thereby benefiting patients. Biosite's Triage(R) rapid
diagnostics are used in approximately 50 percent of U.S. hospitals and in more
than 50 international markets for toxicology screening and diagnosis of
infectious and cardiovascular disease. 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 potential benefits of
the Triage D-Dimer Test, and the commencement of marketing, education and
sales of this new product. Risks and uncertainties include risks regarding
the discovery and product development process generally, risks associated with
the commencement of manufacturing the Triage D-Dimer Test on a commercial
scale and risks related to the continued supply of AGEN's 3B6 antibody,
specific for D-dimer. Other risks and uncertainties that may impact the
Company's business generally include risks associated with the 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, 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.
3B6 D-dimer The Essential Element(TM) is a trademark of AGEN(R) Biomedical
LTD.
(1) Dempfle, C-E, Zips S, Ergul H, Heene D and the FACT Study Group, The
Fibrin Assay Comparison Trial (FACT), J Thromb Haemost 2001: 85:
671-8.
(2) Stein and Hull et al, D-dimer for the Exclusion of Acute Venous
Thrombosis and Pulmonary Embolism, Ann Intern Med. April 2004
(3) Philip S. Wells, Evaluation of D-dimer in the Diagnosis of Suspected
Deep-Vein Thrombosis, NEJM, 2003
(4) J. Kline, et al. Ann Emerg Med. 2004; 44:490-502.
(5) Feied CF: Pulmonary embolism. In: Rosen and Barken, eds, Emergency
Medicine Principles and Practice, 4th ed. 1998; 3: Chapter 111.
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com
Company News On-Call:
http://www.prnewswire.com/comp/116737.html
CONTACT:
Nadine Padilla, VP, Corporate & Investor
Relations of Biosite Incorporated, +1-858-455-4808, ext. 3187,
npadilla@biosite.com
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