FDA-approved AI-driven tool for sepsis diagnosis

Another artificial intelligence (AI)-driven tool approval is in the bag, this time for sepsis diagnosis. The test, Sepsis ImmunoScore, is the first AI diagnostic tool for sepsis to receive the FDA’s go-ahead.

Sepsis is a serious and sometimes deadly condition whereby the body’s response to an infection damages the vital organs. According to the World Health Organization, sepsis claims at least 11 million lives per year, with around 50 million cases annually.

Sepsis can be challenging to diagnose immediately, particularly in critically ill patients. Alarmingly, one in three people who die in hospital had sepsis during their stay, prompting federal agencies to incentivize facilities aiming to mitigate sepsis prevalence. The FDA’s authorization of Sepsis ImmunoScore represents a significant milestone in this process.

So how does it work? Prenosis (IL, USA), the company that developed the tool, first obtained an extensive dataset comprising over 100,000 blood samples and clinical data from 25,000 patients. They then trained an algorithm to identify key health indicators linked to sepsis development.

They refined their AI-driven test to 22 predictive health parameters, including blood-based measures such as inflammatory biomarkers , and vital signs such as temperature and heart rate. The diagnostic tool uses these parameters to calculate a comprehensive risk score of deterioration, categorizing patients into four risk levels from low to very high.

Sepsis ImmunoScore can be integrated directly into electronic health records, which enables the tool to seamlessly analyze a patient’s health metrics and calculate a risk score within 24 hours. This integration into existing workflows also means the tool is easily accessible, and clinicians are provided with a display showing exactly which parameters were used to generate the overall risk score. This transparency is critical for building clinicians’ trust and confidence in the tool.

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The introduction of this AI-powered test coincides with ongoing discussions within healthcare regarding the integration of AI into clinical practice. While these advancements promise improved patient outcomes, concerns regarding the accuracy and potential displacement of frontline healthcare workers persist.

“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,” commented Bobby Reddy, Prenosis Co-Founder and CEO. “Until now, there was no other FDA-authorized AI diagnostic for sepsis, which is why the Sepsis ImmunoScoreTM 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 ImmunoScoreTM to improve care.”

After successfully showcasing the safety and efficacy of Sepsis ImmunoScore to the FDA over 18 months and subsequently securing approval, Prenosis plans to conduct further studies to validate the accuracy and impact of the Sepsis ImmunoScore on clinical decision-making. They also intend to market the tool in hospitals across the US and internationally.