Biosite Reports on Presentation of Preliminary Data From Sepsis Program
March 28 2007 - 6:00AM
PR Newswire (US)
SAN DIEGO and BRUSSELS, Belgium, March 28 /PRNewswire-FirstCall/ --
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. DATASOURCE: Biosite Incorporated CONTACT: Nadine
Padilla, Vice President, Corporate & Investor Relations,
+1-858-805-2820, , or Nicole Beckstrand, Manager, Public Relations,
+1-619-274-1184, , both of Biosite Incorporated Web site:
http://www.biosite.com/ Company News On-Call:
http://www.prnewswire.com/comp/116737.html
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