Biosite Reports on Presentation of Preliminary Data From Sepsis Program
SAN DIEGO and BRUSSELS, Belgium, March 28, 2007 /PRNewswire-FirstCall/ -- Biosite Incorporated 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 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 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.
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Posted: March 2007