Health technology company Prenosis announced Wednesday that its AI-based diagnostic tool for sepsis is the first to receive FDA approval.
Sepsis occurs when the body has a severe, often fatal response to an infection. More than 350,000 adults with sepsis die during hospitalization or are discharged to nursing homes each year, according to the Centers for Disease Control and Prevention. Diagnosing sepsis is known to be very challenging, but early detection is key because patients can deteriorate quickly.
The Prenosis tool, called Sepsis ImmunoScore, uses 22 different parameters such as temperature, heart rate and cell counts to help doctors assess a patient's risk of developing sepsis, the company told CNBC. Doctors and nurses often have to monitor each of these parameters individually. The Prenosis solution uses artificial intelligence to evaluate all of those signs at once. The tool generates an overall risk score and four categories “associated with the patient's risk of worsening,” according to the 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 statement said.
The tool is integrated directly into electronic health records where doctors create and manage patients' medical records. Prenosis said integrating Sepsis ImmunoScore into their existing workflow means it will be easier to use and access. Doctors will also see a screen displaying exactly which parameters were used to calculate the overall risk score.
The Prenosis solution is approved through the FDA's De Novo pathway, meaning the agency has not authorized anything like Sepsis ImmunoScore before. It's a big win for the 10-year-old Chicago-based startup.
While Prenosis is the first company to receive FDA approval for an AI-powered sepsis diagnostic tool, several organizations have built and released similar solutions. For example, Johns Hopkins University has built an artificial intelligence system that aims to detect sepsis symptoms more quickly. A 2022 study published in the journal Nature Medicine found that in severe cases, the university's AI model detected sepsis on average six hours earlier than traditional methods.
Epic Systems, a leading healthcare software company, has also developed an AI-powered sepsis prediction tool, although the company's model has come under significant criticism in recent years. Epic's sepsis model is being 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 “does not predict sepsis poorly,” and that its “widespread adoption despite poor performance raises fundamental concerns about sepsis management at the national level,” the study said.
Epic retracted the findings, and the company published a blog post in which it said healthcare organizations had seen an improvement in sepsis death rates because of its technology. However, Epic reportedly overhauled its sepsis model the following year in an attempt to improve its performance, according to Stat News.
Prenosis told CNBC that although it could have gone straight to market with Sepsis ImmunoScore, it didn't want to try to sell the product without FDA approval. The company said the tool has been ready for about three years, but it wanted to work with regulators to be aware of safety concerns and ensure the technology doesn't cause any harm.
Additionally, the FDA updated its guidance for companies in September 2022 and shared examples of device software functions where it “intends to focus its regulatory oversight.” Software that “analyzes a patient’s medical information to detect a life-threatening condition, such as a stroke or sepsis,” falls into this category, the agency said.
In other words, the agency suggests that companies developing sepsis detection kits should seek official authorization.
Prenosis said it has been working to prove the safety and effectiveness of Sepsis ImmunoScore to the FDA for about 18 months. Now that the company has received agency approval, it will conduct additional studies to prove the tools' accuracy and impact 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.
