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In a first, FDA authorizes AI-driven test to predict sepsis in hospitals

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Bobby Reddy Jr. roamed a hospital as he built his start-up, observing how patient care began with a diagnosis and followed a set protocol. The electrical engineer thought he knew a better way: an artificial intelligence tool that would individualize treatment.

Now, the Food and Drug Administration has greenlighted such a test developed by Reddy’s company, Chicago-based Prenosis, to predict the risk of sepsis — a complex condition that contributes to at least 350,000 deaths a year in the United States. It is the first algorithmic, AI-driven diagnostic tool for sepsis to receive the FDA’s go-ahead, the company said in a statement Wednesday.

“In hospitals and emergency departments, we are still relying on one-size-fits-all, when instead we should be treating each person based on their individual biology,” Reddy, the company’s CEO, said in an interview.

Sepsis occurs when a patient’s immune system tries to fight an infection and ends up attacking the body’s own organs. Managing sepsis is a priority among federal health agencies including the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.

“Sepsis is a serious and sometimes deadly complication,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Technologies developed to help prevent this condition have the potential to provide a significant benefit to patients.”

To build its test, Prenosis acquired more than 100,000 blood samples along with clinical data on hospital patients, and trained its algorithm to recognize the health measures most associated with developing sepsis. The company narrowed its test to 22 parameters, including blood-based measures and other vital signs such as temperature and heart rate. The diagnostic tool now produces a snapshot that classifies a patient’s risk of sepsis in four categories, from low to very high.

Though Prenosis is the first to win FDA authorization for such a test, other companies, including Epic Systems, have already brought to market AI-driven diagnostics for the condition. Epic, known for its software that manages electronic health records, has faced questions about the accuracy of its algorithm for predicting sepsis.

Jacob Wright, an Epic spokesman, said that multiple studies have shown that its diagnostic model for sepsis improved patient outcomes, adding that a second version released in 2022 “has fewer false positives when compared to the first version.” The company is seeking FDA clearance, he said.

Reddy said Prenosis built its technology without initially knowing what problem it would try to solve. An Illinois hospital gave him office space and a badge, allowing him to roam the hospital and observe its staff interacting with patients. “What I saw over and over again is that they really run based on protocols,” he said. He later came across a paper on sepsis, he said, that opened his eyes to how many people die of it. “This is going to be what we do,” he said.

At least 1.7 million adults develop sepsis in a given year, including at least 350,000 who die during their hospitalization or are discharged to hospice care, according to the CDC. Roughly 1 in 3 people who die in a hospital had sepsis during their stay, and federal agencies are aiming to reward facilities that are making strides to reduce the condition.

Those at higher risk of sepsis include adults 65 and older, people with weakened immune systems, and those with a recent severe illness or hospitalization.

The new test comes as hospitals are grappling with the future of medicine and how to best incorporate artificial intelligence into the practice. In some instances, artificial intelligence tools have created tension among front-line workers who worry the technology could lead to inaccurate results or replace staff.

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