“In hospitals and emergency departments, we still rely on one-size-fits-all treatments, but instead treat each person based on their individual biology,” Reddy, the company's CEO, said in an interview. It should be treated,” he said.
Sepsis occurs when a patient's immune system attempts to fight an infection and ends up attacking the body's own organs. Sepsis management has become a priority among federal health agencies such as the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.
To build the test, Prenosis acquired more than 100,000 blood samples along with clinical data from hospitalized patients and trained an algorithm to recognize the health indicators most associated with the development of sepsis. The company has narrowed the test down to 22 parameters, including blood-based measurements and other vital signs such as body temperature and heart rate. The diagnostic tool now creates a snapshot that categorizes a patient's sepsis risk into her four categories, ranging from low to very high.
However Prenosis is the first company to win FDA clearance for such a test, and other companies, including Epic Systems, have already brought AI-powered diagnostics for this condition to market. Epic, known for its software for managing electronic medical records, is facing questions about the accuracy of its algorithms that predict sepsis.
Epic did not immediately respond to a request for comment Wednesday.
Reddy said Prenosis initially built the technology without knowing what problem it was trying to solve. The Illinois hospital gave him office space and a badge that allowed him to walk around the hospital and observe staff interacting with patients. “What I’ve seen over and over again is that they’re actually being executed based on protocols,” he said. Then he came across a paper on sepsis, which opened his eyes to the number of people dying from sepsis, he said. “This is what we do,” he said.
At least 1.7 million adults develop sepsis each year, and at least 350,000 of them die while hospitalized or are discharged to hospice care, according to the CDC. Roughly one in three people who die in hospitals suffer from sepsis while hospitalized, and the federal agency aims to reward facilities that make strides in mitigating the condition.
People at high risk for sepsis include adults over 65, people with weakened immune systems, and people who have recently experienced a serious illness or hospitalization.
The new test comes as hospitals grapple with the future of healthcare and how to best incorporate artificial intelligence into healthcare. In some cases, artificial intelligence tools have created tension among frontline workers who fear the technology will produce inaccurate results or lead to staff turnover.