Beckman Coulter Gets FDA Clearance for Early Sepsis Indicator

Sepsis continues to be a deadly malady that clinicians haven’t figured out how to tackle consistently. A major limitation of treatment is how early clinicians can identify that a patient is showing signs of sepsis.

Beckman Coulter just received FDA clearance for its Early Sepsis Indicator, a cellular biomarker for the company’s DxH 900 hematology analyzer. The test identifies morphological changes within monocyte white blood cells, an indicator that has been shown in clinical studies to point to sepsis.

Relying on a standard blood test, emergency room and ICU clinicians can quickly identify if a given patient is suffering from sepsis or about to do so. This can give them some extra critical time to begin antibiotic regimens that can save a patient’s life.

From Beckman Coulter:

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% and, together with clinical signs and symptoms, improves their confidence in helping to rule out sepsis by 63%.

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 industry-leading 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. The Early Sepsis Indicator is also part of Beckman Coulter’s clinically impactful menu that matters which address the most prevalent and costly health conditions.