A new AI tool for sepsis diagnosis developed from research by Carle Illinois College of Medicine faculty member Rashid Bashir has received marketing approval from the Food and Drug Administration. Called Sepsis ImmunoScore™, the new tool uses algorithms to combine deep biological data with broad clinical data to elucidate patterns in the human biological response. Early detection of sepsis leads to prompt treatment before damage occurs. Carle Foundation Hospital is the first health care system to participate in the research leading to the tool's development.
“Carle is where it all started,” Bobby Reddy Jr., co-founder of Chicago-based Prenosis said. He and Bashir, dean of the University of Illinois' Grainger College of Engineering and a professor at CI MED, co-founded Prenosis, which is working with Roche Diagnostics to bring the sepsis tool to hospitals across the country.
Sepsis is a serious condition in which the infection-fighting processes in the body stop working and there is a dramatic drop in blood pressure. This can damage the lungs, liver and other organs. Harm can occur subtly and unexpectedly. Severe organ damage can lead to septic shock and death.
It began when Reddy, an engineer at the University of Illinois Urbana-Champaign was working in the Biomedical Research Center at the Mills Breast Cancer Institute Urbana about 10 years ago and he started chatting with Carle Health staff and doctors who work in the laboratories. He learned not only about the need to develop a tool for treating sepsis, but also how to approach a problem a bit differently than most engineers. Speaking metaphorically, Reddy said, “Engineers tend to design a hammer and look for a nail to fix and we really need to do the opposite.”
The first study involved the use of blood samples and biophysical data from 2,000 patients. A physician would diagnose a possible infection based on how a patient presented and the doctor would order a diagnostic workup from a blood draw. The test is completed in 30 to 60 minutes. The Immunoscore tool uses lab-based biomarkers in the blood, real-time clinical data, and AI to evaluate a patient’s likelihood of developing sepsis and stimulate earlier treatment in patients presenting with possible sepsis.
Clinical champion for the research is critical care physician and CI MED clinical professor Karen White, MD, PhD, who said, “The more patients you put into the algorithm the better the tool is at predicting sepsis and therefore providing early intervention for the patient’s condition.” Dr. White, Reddy, and Bashir started collecting the information, and graduate students who worked with Bashir began the machine learning.
“It does not work without data and the data started at Carle,” White said. The project involved a large number of physicians, research staff, and Internal Medicine residents at Carle Health who helped recruit patients, collect data, and obtain samples. Carle residents helped to interpret the clinical data for the initial training of the AI tool, which was a great learning experience.
Carle is one of three Illinois hospitals that helped build the Prenosis biobank and dataset, which now consists of more than 100,000 blood samples from more than 25,000 patients housed in the Prenosis Biological Safety Level 2 lab in Chicago.
"I'm proud Carle played a founding role in the new Sepsis ImmunoScore tool. Early sepsis detection through advanced technologies like AI will enhance care and support our caregivers' lifesaving work. Continued collaboration will be key to further refining solutions and integrating them smoothly into clinical workflows, ensuring more patients receive timely sepsis diagnosis and care,” Lakita Scott, vice president, Quality at Carle Health, said.
Carle Health continues its partnership with Prenosis today in an ongoing clinical study to evaluate how physicians interact with the ImmunoScore tool to help improve its utility in busy clinical settings. “We look forward to continual improvement in our ability to recognize and treat patients with sepsis through our partnership with Prenosis and the University of Illinois,” Carle Vice President for Research Jennifer Eardley, PhD, said. “Projects like this that have direct impact on our patients is why Carle invests in research.”
Editor's note: The original version of this article by Carle Health can be found here.