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Early Sepsis Indicator Receives FDA Clearance

Beckman Coulter announced the Early Sepsis Indicator received 501(k) clearance on Thursday morning.

The US Food and Drug Administration granted 510(k) clearance for the Early Sepsis Indicator to Beckman Coulter. The Early Sepsis Indicator is hematology-based cellular biomarker designed to help emergency department physicians identify patients with sepsis or at an increased risk of developing sepsis.

The Early Sepsis Indicator is automatically reported as part of a routine complete blood count with different for adult emergency department patients. A positive result signals a higher probability of sepsis and a negative result signals lower probability of sepsis.

“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,” said Peter Soltani, Ph.D., senior vice president and general manager of the hematology business at Beckman Coulter.

Approval of the device is based upon data from the Sepsis Clinical Accuracy Performance on DxH 800 Test Summary Report. The report found that, compared to white blood cells alone, the Early Sepsis Indicator increases a clinician’s suspicion of sepsis by 43%. In addition to this, investigators noted a 63% improvement in a physician’s confidence in helping to rule out sepsis in a patient.

"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,” said Elliott Crouser, MD, principal investigator in the clinical trial, The Ohio State University Wexner Medical Center.