FDA Authorizes Prenosis’ Sepsis Immunoscore

Prenosis, an artificial intelligence company for precision medicine in acute care, has received FDA marketing authorization for its Sepsis ImmunoScore using the De Novo pathway. This marks the first-ever FDA marketing authorization of an AI diagnostic tool for sepsis, an extremely complex condition that is difficult to diagnose early. 
 
Within 24 hours, the Sepsis ImmunoScore combines biomarkers and clinical data to aid in the risk assessment for the presence of or progression to sepsis. This AI/machine learning software as a medical device (AI SaMD) that holistically evaluates the patient’s biological status to output a risk score and four discrete risk categories.
 
Risk categories correlate to a patient’s risk of deterioration, represented by length of stay in the hospital, in-hospital mortality, and escalation of care within 24 hours (ICU admission, mechanical ventilation placement, and/or vasopressor use). This combination of both diagnostic and predictive information had never previously been available in a legally marketed device for sepsis.
 
“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 Prenosis Co-Founder and CEO, Bobby Reddy, Jr, Ph.D. “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.”
 
The ImmunoScore software can be directly integrated into hospital Electronic Medical Records, and an intuitive display shows how each of the individual patient’s parameters was used to calculate their final sepsis score. This breakdown enables a true clinician-AI partnership, facilitating faster treatment decisions, improved outcomes, and quality metrics.
 
“The Sepsis ImmunoScore™ FDA authorization marks an important step in helping hospital systems provide better care,” Reddy added. “Similar to how sequencing technology enabled the precision medicine revolution in cancer, our powerful Immunix™ platform has the potential to unlock valuable insights to enable the creation of precision therapeutics guided by AI diagnostics. To date, this type of approach has been used predominantly in healthcare outside of emergency departments and hospitals. Prenosis seeks to change this by catalyzing a personalized medicine revolution in acute care.” 
 
The Sepsis ImmunoScore was built using Prenosis’ Immunix precision medicine platform, which simultaneously empowers the development and validation of new precision medicine tools and the real-time implementation of those tools to improve patient care and outcomes.