Early Sepsis Indicator gets FDA 510(k) clearance.

Beckman Coulter’s new hematologic biomarker has been given 510(k) clearance from the FDA. The Early Sepsis Indicator is a hematology-based cellular biomarker that could completely change the way clinicians tackle sepsis triage and diagnosis. It reinforces a clinician’s suspicion of sepsis by 43% and, when considered alongside clinical signs and symptoms, improves their confidence in helping to rule out sepsis by 63%. In a clinical trial, its unique monocyte distribution width biomarker best discriminated sepsis from all other conditions when combined with the current standard of care.
Elliott Crouser, MD, principal investigator in the clinical trial, The Ohio State University Wexner Medical Centre, said: “Sepsis is a leading cause of hospital mortality, and our study findings indicate this simple biomarker test improves the detection of sepsis at an early stage when it is most responsive to treatment. It’s an important breakthrough and it’ll likely make a big impact in the care of sepsis, as it is easy to implement and works best when combined with other widely available sepsis diagnostic tools at the time of the initial hospital encounter.”
Peter Soltani, senior vice president and general manager of the hematology business at Beckman Coulter, said: “The devastating clinical consequences and financial burden of sepsis are now recognized worldwide. We are privileged to provide emergency department personnel and clinical laboratorians the tools and information they need to more efficiently recognize sepsis and make treatment decisions as quickly as possible. Knowing sooner and acting faster is the name of the game in the fight against sepsis, and we believe that the Early Sepsis Indicator has the potential to revolutionize the clinical approach to sepsis triage and diagnosis.”