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? (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? 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.