FDA Authorizes AI Sepsis Prediction, Detection Tool

On April 3, 2024, the United States FDA granted Prenosis Inc. De Novo marketing authorization for Sepsis ImmunoScore. The tool is an artificial intelligence (AI) and machine learning (ML) software that can predict the risk of sepsis and aid in early diagnosis, allowing for prompt treatment.

"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, PhD, Prenosis Co-Founder and CEO, in the press release. "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."

Sepsis is an extreme and potentially fatal bodily response to infection caused by a series of chain reactions in the body. According to the CDC, 1.7 million adults in the US develop sepsis each year.

This condition remains a significant challenge for the US healthcare system as it contributes to one-third of hospital deaths. Beyond fatality, sepsis — even if it is treated — can cause permanent health complications.

Specific populations, including adults ages 65 and older, immunocompromised individuals, those with chronic medical conditions, individuals with a recent severe illness or hospitalization, infants, and individuals with a history of sepsis, are at an increased risk for the disease. However, anyone may be impacted by sepsis.

Prenosis claims that Sepsis ImmunoScore uses 22 diverse parameters, including biomarkers and clinical data, to assess sepsis risk within 24 hours of assessment. The software offers a risk score and analyzes risk across specific categories, including the patient’s risk of deterioration by length of stay, in-hospital mortality, and escalation of care within 24 hours.

"The Sepsis ImmunoScore FDA authorization marks an important step in helping hospital systems provide better care," added Reddy. "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."