Signage is seen outside the U.S. Food and Drug Administration headquarters in White Oak, Maryland, August 29, 2020.
Andrew Kelly | Reuters
Health technology company Prenosis announced Wednesday that its artificial intelligence-based sepsis diagnostic tool is the first to receive approval from the U.S. Food and Drug Administration.
Sepsis occurs when the body reacts in an extreme way to an infection and is often fatal. More than 350,000 adults with sepsis die each year while hospitalized or are discharged to hospice care, according to the Centers for Disease Control and Prevention. Sepsis is notoriously difficult to diagnose, but early detection is essential as patients’ conditions can deteriorate rapidly.
Prenosis’ tool, called Sepsis ImmunoScore, uses 22 different parameters such as temperature, heart rate and cell count to help clinicians assess a patient’s risk of sepsis, the company told CNBC. Doctors and nurses often need to monitor each of these parameters individually. Prenosis’ solution uses AI to evaluate all of these markers at once. The tool generates an overall risk score and four categories that “correlate with a patient’s risk of deterioration,” according to a release.
Sepsis ImmunoScore was built using Prenosis’ Immunix platform, which is based on a dataset of more than 100,000 blood samples from 25,000 different patients, the release said.
The tool is integrated directly into electronic health records where clinicians create and manage patient medical records. Integrating Sepsis ImmunoScore into existing workflows means it will be easy to use and access, Prenosis said. Clinicians will also see a screen showing exactly which parameters were used to calculate the overall risk score.
Prenosis’ solution was approved via the FDA’s De Novo pathway, meaning the agency has never authorized anything like Sepsis ImmunoScore before. It’s a big win for the 10-year-old Chicago-based startup.
Although Prenosis is the first 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 aims to detect sepsis symptoms more quickly. A 2022 study published in Nature Medicine found that in severe cases, the university’s AI model detected sepsis an average of six hours earlier than traditional methods.
Epic Systems, a leading provider of healthcare software, has also developed an AI-based sepsis prediction tool, although the company’s model has faced significant criticism in recent years . Epic’s sepsis model is used in hundreds of hospitals across the United States, according to a 2021 study published in JAMA Internal Medicine. But the researchers found that the model “poorly predicts sepsis” and that “its widespread adoption despite poor performance raises fundamental concerns about sepsis management at the national level,” the study said.
Epic pushed back on the findings, and the company published a blog post saying that healthcare organizations have seen sepsis death rates improve with its technology. Despite this, Epic reportedly overhauled its sepsis model the following year in an attempt to improve its performance, according to Stat News.
Prenosis told CNBC that while it could have directly marketed Sepsis ImmunoScore, it did not want to try to sell the product without FDA approval. The company said the tool was ready about three years ago, but it wanted to work with regulators to be aware of safety concerns and ensure the technology wouldn’t cause harm.
Additionally, the FDA updated its guidance for businesses in September 2022 and shared examples of device software functions on which it “intends to focus its regulatory oversight.” The agency said software that “analyzes patient-specific medical information to detect a life-threatening illness, such as stroke or sepsis,” falls into this category.
In other words, the agency suggests that companies developing sepsis detection tools seek official approval.
Prenosis said it has worked to demonstrate the safety and effectiveness of Sepsis ImmunoScore to the FDA for approximately 18 months. Now that the company has received agency approval, it will conduct additional studies to demonstrate the accuracy and impact of the tools on clinical decision-making. Prenosis will begin selling the tool to hospitals in the United States and eventually to hospitals around the world, the company said.
cnbc
