The FDA has granted marketing authorization for the Sepsis ImmunoScore, “an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis and prediction of sepsis. This signifies the first-ever FDA marketing authorization of an AI diagnostic tool for sepsis.”
The Sepsis ImmunoScore uses 22 parameters to “evaluate the patient’s biological status to output a risk score and four discrete risk categories” for sepsis. The resulting 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).”
The Sepsis ImmunoScore is “integrated directly into hospital electronic medical records” and breaks down a patient’s risk score by each parameter.
The device was built using Prenosis’ Immunix precision medicine platform, which built a “proprietary biobank and dataset consisting of more than 100,000 blood samples from over 25,000 patients housed in Prenosis’ Biological Safety Level 2 lab in Chicago.” These were used to develop AI algorithms to “elucidate patterns in rapid immune response” that result in sepsis.
Sepsis, “which occurs when a person has an overactive response to an infection, costs the U.S. healthcare system billions of dollars and kills millions of people every year – more than all cancers combined.”
PR Newswire has the release.
