Sepsis, a condition marked by an excessive immune response to infection, presents a formidable diagnostic challenge, with significant implications for global health and healthcare budgets. Annually, sepsis is responsible for more fatalities than the combined total of all cancer types and huge expenses for healthcare systems. Sepsis survivors often endure severe, lasting impacts on their lives even after discharge. Now, a revolutionary artificial intelligence (AI) diagnostic and predictive tool for early sepsis detection has significant potential to save lives and reduce hospital length of stay.

The Sepsis ImmunoScore from Prenosis (Chicago, IL, USA) is an AI software as a medical device (AI SaMD) for guiding the rapid diagnosis and prediction of sepsis. It assesses the risk of sepsis onset or progression within 24 hours following a patient's evaluation in emergency or hospital settings. By analyzing a comprehensive array of 22 biomarkers and clinical data points, the Sepsis ImmunoScore evaluates the patient's overall biological state, providing a risk score and categorizing patients into four distinct risk levels. These classifications are indicative of potential clinical outcomes, such as hospital stay duration, mortality risk, and the necessity for escalated care measures like ICU admission, mechanical ventilation, or vasopressor administration within the next 24 hours.

By integrating seamlessly into hospital electronic health records (EHRs), Sepsis ImmunoScore’s software becomes easily accessible to clinicians. It features a user-friendly interface that details the contribution of each parameter to the overall sepsis risk assessment, fostering a transparent relationship between clinicians and the AI tool. This transparency is crucial for encouraging rapid and informed clinical decisions, thereby enhancing patient care quality and hospital efficiency. The Sepsis ImmunoScore was built using the Immunix precision medicine platform from Prenosis which is designed to advance personalized medicine in acute care settings. The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Sepsis ImmunoScore using the De Novo pathway, making it the first-ever AI sepsis diagnostic to be granted marketing authorization by the FDA.

"FDA authorization of a sepsis diagnostic tool with significant predictive power is a landmark event for people that could ever be at risk of sepsis at some point in their lives," said Bobby Reddy, Jr, Ph.D., Prenosis Co-Founder and CEO. "Until now, there was no other FDA authorized AI diagnostic for sepsis, which is why the Sepsis ImmunoScore had to be granted marketing authorization through the De Novo pathway. FDA authorization offers yet another important piece of evidence of the potential of the Sepsis ImmunoScore to improve care."

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