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2024'11.25.Mon
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2007'03.30.Fri
Biosite Reports on Presentation of Preliminary Data From Sepsis Program
March 28, 2007





    SAN DIEGO and BRUSSELS, Belgium, March 28
/Xinhua-PRNewswire/ -- Biosite Incorporated (Nasdaq: BSTE)
today announced preliminary results of a sample collection
study aimed at identifying a biomarker panel that could
potentially aid in the assessment for risk of sepsis
progression. Sepsis is an often fatal condition with
limited therapeutic options. Clinical investigator, Emanuel
P. Rivers, M.D., MPH, vice chairman and director of research
at the department of emergency medicine at Henry Ford
Hospital in Detroit, presented the data at the 27th
International Symposium on Intensive Care and Emergency
Medicine (ISICEM) in Brussels. 

    "In this study, we identified a combination of
three biomarkers that performed better when compared to
several other individual biomarkers," said Dr. Rivers.
"This preliminary study suggests that these biomarkers
may be a clinically useful tool in the assessment of risk
of sepsis progression within 72 hours of patients
presenting to the emergency department and meeting the
diagnostic criteria for sepsis.  We look forward to future
studies that will be aimed at substantiating these
findings."

    "We are encouraged by this study and will advance
this sepsis biomarker panel to the next step in our
clinical process," said Ken Buechler, Ph.D., Biosite
president and chief scientific officer. "We are on
track to launch a prospective multi-center clinical study
in the second quarter of 2007 to validate the clinical
utility of this panel and compile data needed for an FDA
submission." 

    The biomarkers on the panel, neutrophil
gelatinase-associated lipocalin (NGAL), c-reactive protein
(CRP), and macrophage inflammatory protein-3 (MIP-3), were
selected from 150 biomarkers studied through the Biosite
Discovery program. The panel incorporates Biosite's
proprietary MultiMarker Index(TM) (MMX) Value feature that
uses an algorithm to generate a single quantitative result
from multiple simultaneous biomarker measurements. Biosite
intends to commercialize the panel of biomarkers under the
product name Triage(R) Sepsis Panel. 

    In this study, blood samples were collected from
approximately 1,000 patients presenting to the emergency
department with signs and symptoms of sepsis.  Samples were
analyzed at Biosite using a prototype device.  Following are
preliminary study findings:

    -- The study data were based on samples from initial
blood draws,
       suggesting that the test may be useful in the rapid
assessment
       of patients. 
    -- The sepsis biomarker panel may have clinical utility
in risk
       assessment of patients presenting to the hospital
and meeting
       diagnostic criteria for sepsis.
    -- The sepsis biomarker panel performed better as a
risk
       assessment tool than markers in the literature,
including
       procalcitonin and C-reactive protein.

    A webcast of Dr. Rivers' presentation will be archived
on the Biosite website at http://www.biosite.com until
April 26, 2007. Dr. Rivers is a consultant to Biosite.

    About the Triage Sepsis Panel

    The Triage Sepsis Panel is a rapid point-of-care test
intended to use simultaneous measurements of MIP-3, CRP and
NGAL to aid in the assessment for risk of sepsis progression
within 72 hours of patients presenting to the emergency
department and meeting diagnostic criteria for sepsis. 
Biosite expects to commence a multi-center validation study
called MINDSET (MultiMarker Index for the Risk Assessment of
Sepsis in the Emergency Department) in the second quarter of
2007.  The study is aimed at generating data to support a
submission to the U.S. Food and Drug Administration (FDA).
The Company also plans to seek CE marking for the product
later this year.

    Biosite is also evaluating other potential products in
the category of sepsis, including biomarker targets that
may be useful in the diagnosis of septic patients. Biosite
has collected approximately 4,000 patient samples that are
useful for the study of sepsis.

    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 and risk assessment of critical diseases and
health conditions. The Biosite(R) Triage(R) rapid
diagnostic tests are used in more than 70 percent of U.S.
hospitals and in more than 60 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 are subject to certain 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 concerning the Company's plan to
initiate MINDSET, a multi-center study to validate the
clinical utility of the Triage Sepsis Panel, in the second
quarter of 2007, the expectation that the results of the
MINDSET study will adequately support a submission to the
FDA for the Triage Sepsis Panel, the Company's plans to
seek CE marking of the Triage Sepsis Panel later this year,
the market need for a rapid sepsis test, the potential
utility of a sepsis test,  the Company's ability to achieve
regulatory clearance for a sepsis test and the Company's
ability to develop other potential products in the category
of sepsis. Risks and uncertainties include risks associated
with the Company's ability to initiate and complete the
MINDSET study in the timeframe anticipated, risks that the
results of the MINDSET study may not be consistent with the
results from the Company's initial training study, the
Company's ability to manufacture the Triage Sepsis Panel on
a commercial scale or other manufacturing constraints,
potential contract disputes or patent conflicts, the
availability of competitive products from companies with
greater capital and resources, the extent to which our
products and products under development are successfully
developed and gain market acceptance and other risks in the
clinical, research and development process generally. Other
risks that should be considered include the other risks
detailed in Biosite's most recent Annual Report on Form
10-K, and subsequent SEC filings. The Company disclaims,
however, any intent or obligation to update these
forward-looking statements. Copies of Biosite'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. MultiMarker Index(TM) is a trademark of
Biosite Incorporated. The Company's logo is a trademark of
Biosite Incorporated.



    For more information, please contact:

     Nadine Padilla, Vice President
     Corporate & Investor Relations
     Biosite Incorporated
     Tel:   +1-858-805-2820
     Email: npadilla@biosite.com 

     Nicole Beckstrand
     Manager, Public Relations
     Biosite Incorporated
     Tel:   +1-619-274-1184
     Email: nbeckstrand@biosite.com
PR
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