Prenosis nabs de novo nod for AI-powered sepsis risk tool

The diagnostics startup Prenosis has scored a groundbreaking green light from the FDA for an artificial intelligence-powered tool that aims to spot the early signs of sepsis.

The agency’s de novo clearance for the Chicago-based company’s ImmunoScore software allows it to help predict cases where the body’s immune system may severely overreact to an infection and cause damage to healthy organs and tissues. 

The AI assessment aid takes in 22 different biomarkers and pieces of clinical data and assigns a patient to one of four risk levels, linked to the possibility of or progression to sepsis within 24 hours of being checked out in a hospital or emergency room.

The system itself does not provide alerts to clinicians; instead, it may give them time to plan, as the risk categories align with a patient’s potential length of stay or their chances of death while in the hospital, in addition to the possible need for intensive care or assisted ventilation.

“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,” Prenosis co-founder and CEO Bobby Reddy Jr. said in a statement

The ImmunoScore sepsis software, which can integrate with electronic medical records, was built on Prenosis’ Immunix platform. Designed to help develop precision medicine tools, Immunix is based on a biobank and dataset assembled from more than 100,000 blood samples taken from over 25,000 patients.

“To date, this type of approach has been used predominantly in healthcare outside of emergency departments and hospitals,” said Reddy. “Prenosis seeks to change this by catalyzing a personalized medicine revolution in acute care.”