Prenosis says AI tool for sepsis approved by FDA

The health technology company Prenosis on Wednesday announced its artificial intelligence-powered diagnostic tool for sepsis is the primary to receive approval from the U.S. Food and Drug Administration. 

Sepsis occurs when the body has an extreme response to an infection, and it is commonly deadly. Greater than 350,000 adults with sepsis die during hospitalization or are discharged to hospice annually, in line with the Centers for Disease Control and Prevention. Sepsis is notoriously difficult to diagnose, but early detection is vital since patients can deteriorate quickly. 

Prenosis’ tool, called Sepsis ImmunoScore, uses 22 different parameters like temperature, heart rate and cell counts to assist clinicians assess a patient’s risk of sepsis, the corporate told CNBC. Doctors and nurses often have to observe each of those parameters individually. Prenosis’ solution uses AI to guage all of those markers directly. The tool generates an overall risk rating and 4 categories that “correlate to a patient’s risk of decay,” in line with a release.   

Sepsis ImmunoScore was built using Prenosis’ Immunix platform, which relies on a dataset of greater than 100,000 blood samples from 25,000 different patients, the discharge said. 

The tool is integrated directly into electronic health records where clinicians create and manage patients’ medical records. Embedding Sepsis ImmunoScore inside existing workflows means it’s going to be easy to make use of and access, Prenosis said. Clinicians will even see a display that shows exactly which parameters were used to calculate the general risk rating. 

Prenosis’ solution was approved through the FDA’s De Novo pathway, which implies the agency has not authorized anything like Sepsis ImmunoScore before. It’s an enormous win for the 10-year-old Chicago-based startup.

While Prenosis is the primary company to receive FDA approval for its AI diagnostic tool for sepsis, several organizations have built and released similar solutions. For example, Johns Hopkins University has built an AI system that goals to catch sepsis symptoms more quickly. A 2022 study published in Nature Medicine found that, in severe cases, the university’s AI model detected sepsis a median of six hours sooner than traditional methods.  

Epic Systems, a number one health-care software vendor, has also developed an AI-powered sepsis prediction tool, though the corporate’s model has been subject to substantial criticism lately. Epic’s sepsis model is utilized in tons of of hospitals across the U.S., in line with a 2021 study published in JAMA Internal Medicine. But researchers found that the model “poorly predicts sepsis,” and that “its widespread adoption despite poor performance raises fundamental concerns about sepsis management on a national level,” the study said. 

Epic pushed back on the findings, and the corporate published a blog post that said health-care organizations have seen sepsis mortality rates improve due to its technology. Even so, Epic reportedly overhauled its sepsis model the next 12 months in an try to improve its performance, in line with Stat News. 

Prenosis told CNBC that while it could have gone straight to market with Sepsis ImmunoScore, it didn’t wish to attempt to sell the product without FDA approval. The corporate said the tool was ready around three years ago, nevertheless it desired to work with regulators to take heed to safety concerns and make sure that the technology doesn’t cause harm.

Moreover, the FDA updated its guidance for firms in September 2022 and shared examples of device software functions where it “intends to focus its regulatory oversight.” The agency said software that “analyzes patient-specific medical information to detect a life-threatening condition, akin to stroke or sepsis,” falls under this category. 

In other words, the agency suggests firms developing sepsis detection tools should seek official authorization. 

Prenosis said it worked to display the protection and efficacy of Sepsis ImmunoScore to the FDA for around 18 months. Now that the corporate has secured the agency’s approval, it’s going to conduct additional studies to display the tools’ accuracy and impact on clinical decision-making. Prenosis will begin to sell the tool to hospitals within the U.S. and eventually to hospitals across the globe, the corporate said.