Early Sepsis Indicator Receives 510(k) Clearance from FDA

New Hematologic Biomarker Test Provides New Approach to Sepsis Triage and Diagnosis

Beckman Coulter today announced that it has received 510(k) clearance from the FDA for its Early Sepsis Indicator, a first-of-its-kind, hematology-based cellular biomarker that is designed to help emergency department physicians identify patients with sepsis or who are at increased risk of developing sepsis.

As part of the pivotal clinical trial for the Early Sepsis Indicator, findings showed that the unique monocyte distribution width (MDW) biomarker best distinguished sepsis from all other conditions when combined with the current standard of care. Dr. Derek Angus, chair of the Department of Critical Care Medicine at UPMC (University of Pittsburgh Medical Center), a collaborator in the study, said that the Early Sepsis Indicator is “a novel feature in that it is exploiting the way in which white blood cell counts are already calculated.”

The Early Sepsis Indicator is automatically reported as part of a routine complete blood count (CBC) with differential for adult emergency department patients. A positive Early Sepsis Indicator result signals a higher probability of sepsis, enabling physicians to initiate lifesaving treatments faster. Conversely, a negative reading indicates a lower probability of sepsis. Compared to the traditional method of reviewing white blood cell count alone, the Early Sepsis Indicator strengthens a clinician’s suspicion of sepsis by 43% and, together with clinical signs and symptoms, improves their confidence in helping to rule out sepsis by 63%.

Source: Beckman Coulter, April 18, 2019