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Beckman Coulter Early Sepsis Indicator Granted FDA Clearance

NEW YORK (360Dx) – Beckman Coulter, a Danaher company, today announced that the US Food and Drug Administration has granted 510(k) clearance for its Early Sepsis Indicator ­— a hematology-based cellular biomarker to help emergency department physicians identify patients that have sepsis or are at increased risk of developing sepsis.

Results from the Early Sepsis Indicator are automatically reported as part of a routine complete blood count with differential test conducted for adult emergency department patients. A positive result signals a higher probability of sepsis, enabling physicians to initiate lifesaving treatments faster, and a negative reading indicates a lower probability of sepsis, Beckman Coulter said.

Compared to reviewing white blood cell count alone, the Early Sepsis Indicator strengthens a clinician’s suspicion of sepsis by 43 percent, and when the results are combined with clinical signs and symptoms, a clinician's confidence in helping to rule out sepsis improves by 63 percent, the firm said, citing findings from a pivotal clinical trial for the product.

Additional findings from the pivotal clinical trial showed that Beckman Coulter’s monocyte distribution width biomarker, on which the sepsis indicator is based, discriminated sepsis from all other conditions when combined with the current standard of care.

Elliott Crouser, principal investigator in the trial, who works at the Ohio State University Wexner Medical Center, said in a statement that the study findings indicate the 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."

Beckman Coulter said that the Early Sepsis Indicator can be used in conjunction with the firm's Multidiscipline Reflex Rules in its Remisol Advance middleware, which connects laboratory information systems and instrumentation. The reflex rules can be used to create customized, automated reflex panels of Beckman Coulter's portfolio of in vitro diagnostic tests employed in the current sepsis identification and management care pathway. The tests span multiple disciplines, including hematology, clinical chemistry, immunoassay, microbiology, and urinalysis, the firm said.