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.
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com
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CONTACT:
Nadine Padilla, Vice President, Corporate &
Investor Relations, +1-858-805-2820, npadilla@biosite.com, or
Nicole Beckstrand, Manager, Public Relations, +1-619-274-1184,
nbeckstrand@biosite.com, both of Biosite Incorporated
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