Early Sepsis Indicator receives 510(k) clearance from FDA

April 19, 2019

Beckman Coulter announced that its Early Sepsis Indicator has received 510(k) clearance from the FDA. Sepsis is a global healthcare crisis that affects more than 30 million people worldwide. The Early Sepsis Indicator is a first-of-its-kind, hematology-based cellular biomarker that is designed to help emergency department physicians identify patients with sepsis or at increased risk of developing sepsis.

As part of the pivotal clinical trial for the Early Sepsis Indicator, findings showed that Beckman Coulter’s unique monocyte distribution width (MDW) biomarker best discriminated sepsis from all other conditions when combined with the current standard of care.

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 reviewing white blood cell count alone, the Early Sepsis Indicator strengthens a clinician’s suspicion of sepsis by 43 percent and, together with clinical signs and symptoms, improves their confidence in helping to rule out sepsis by 63 percent.

The Early Sepsis Indicator can be used in conjunction with Beckman Coulter’s patented Multidiscipline Reflex Rules in REMISOL Advance middleware. These reflex rules can create customized, automated reflex panels of Beckman Coulter’s portfolio of in vitro diagnostic tests in the current sepsis identification and management care pathway across multiple disciplines, including hematology, clinical chemistry, immunoassay, microbiology, and urinalysis.

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