Health technology company Prenosis announced Wednesday that its artificial intelligence-based sepsis diagnostic tool is the first to receive approval from the US Food and Drug Administration.
Sepsis occurs when the body has an extreme response to an infection and is often fatal. According to the Centers for Disease Control and Prevention, more than 350,000 adults with sepsis die during hospitalization or are discharged to hospice each year. Sepsis is very difficult to diagnose, but early detection is key as patients can deteriorate quickly.
Prenosis' tool, called Sepsis ImmunoScore, uses 22 different parameters such as temperature, heart rate and cell count to help doctors assess a patient's risk of sepsis, the company told CNBC. Doctors and nurses often have to monitor each of these parameters individually. Prenosis' solution uses AI to evaluate all of those markers at once. The tool generates an overall risk score and four categories that “correlate to a patient's risk of deterioration,” according to a statement.
Sepsis ImmunoScore was created using Prenosis' Immunix platform, which is based on a data set of more than 100,000 blood samples from 25,000 different patients, according to the release.
The tool integrates directly into electronic medical records where physicians create and manage patients' medical records. Integrating Sepsis ImmunoScore into existing workflows means it will be easy to use and access, Prenosis said. Doctors will also see a screen showing exactly which parameters were used to calculate the overall risk score.
The Prenosis solution was approved through the FDA's De Novo pathway, meaning the agency has not previously authorized anything like Sepsis ImmunoScore. It's a big win for the 10-year-old Chicago-based startup.
While Prenosis is the first company to receive FDA approval for its AI sepsis diagnostic tool, several organizations have created and launched similar solutions. For example, Johns Hopkins University has created an artificial intelligence system that aims to detect the symptoms of sepsis more quickly. A 2022 study published in Nature Medicine found that in severe cases, the university's artificial intelligence model detected sepsis an average of six hours earlier than traditional methods.
Epic Systems, a leading healthcare software provider, has also developed an AI-based sepsis prediction tool, although the company's model has come under substantial criticism in recent years. Epic's sepsis model is used in hundreds of U.S. hospitals, 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 its poor performance raises fundamental concerns about sepsis management nationally,” according to the study.
Epic rejected the findings and the company published a blog post saying that healthcare organizations have seen sepsis mortality rates improve thanks to its technology. Still, Epic reportedly revised its sepsis model the following year in an attempt to improve its performance, according to Stat News.
Prenosis told CNBC that while he could have gone directly to market with Sepsis ImmunoScore, he 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 does not cause harm.
Additionally, the FDA updated its guidance for companies in September 2022 and shared examples of device software features on which it “intends to focus its regulatory oversight.” The agency said software that “analyzes patient-specific medical information to detect a life-threatening condition, such as a stroke or sepsis,” falls into this category.
In other words, the agency suggests that companies developing sepsis screening tools should seek official authorization.
Prenosis said it worked to demonstrate the safety and effectiveness of Sepsis ImmunoScore to the FDA for about 18 months. Now that the company has obtained agency approval, it will conduct additional studies to demonstrate the tools' accuracy and impact on clinical decision-making. Prenosis will begin selling the tool to U.S. hospitals and eventually to hospitals around the world, the company said.
