April 18, 2019 -- Beckman Coulter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Early Sepsis Indicator, a hematology-based cellular biomarker designed to assist emergency department physicians with the triage and diagnosis of sepsis.
In a clinical trial of the Early Sepsis Indicator, researchers demonstrated that the company's monocyte distribution width (MDW) biomarker was able to discriminate sepsis from all other conditions when combined with the current standard of care.
Test results from the Early Sepsis Indicator are reported for adult patients as part of a routine complete blood count (CBC) with differential. A positive result signifies that an individual has a higher probability of sepsis, which can enable physicians to start treatment immediately, Beckman Coulter said. A negative reading, on the other hand, indicates a lower probability of sepsis.
The company believes the Early Sepsis Indicator strengthens a clinician's suspicion of sepsis by 43% over reviewing white blood cell count alone. When combined with clinical signs and symptoms, it can improve confidence in helping to rule out sepsis by 63%, Beckman Coulter said.
The Early Sepsis Indicator is designed to be used in conjunction with Beckman Coulter's Multidiscipline Reflex Rules in Remisol Advance middleware.