LifeBridge Health's Sinai Hospital in Baltimore has recently implemented Prenosis’ AI-powered diagnostic tool, the Sepsis ImmunoScore, to improve the detection of sepsis. This initiative aims to bring a research-backed solution directly to patients’ bedside, addressing a critical need in healthcare.
Developed by the Chicago-based Prenosis, the Sepsis ImmunoScore is designed to analyze 22 specific parameters related to a patient’s biological immune response. This comprehensive analysis enables healthcare professionals to spot the early signs of sepsis and forecast its progression within just 24 hours. Notably, the tool received the first authorization from the U.S. Food and Drug Administration (FDA) for software designed to diagnose sepsis back in 2024, approved through the De Novo pathway.
A recent study published in the New England Journal of Medicine has confirmed that the Sepsis ImmunoScore exhibits high accuracy for diagnosing sepsis, while also predicting critical outcomes such as hospitalization duration, ICU admissions, and mortality rates during patient stays.
Sepsis represents one of the most difficult conditions to manage within the U.S. healthcare system. According to data from the U.S. Centers for Disease Control and Prevention (CDC), at least 1.7 million adults and over 18,000 children develop sepsis each year. Tragically, more than 350,000 adults and 1,800 children who contract the condition do not survive their hospitalization or end up in hospice care.
The diagnosis of sepsis is often fraught with challenges. Gregory Corcoran, M.D., chief of emergency medicine at LifeBridge Health, emphasized, "Sepsis poses significant diagnostic uncertainty from a patient’s arrival to the emergency department. The confirmation often relies on blood culture results, which can take several days."
This ambiguity can lead to either overtreatment with unnecessary antibiotics—risking increased antibiotic resistance—or undercounting subtle cases, delaying essential treatment and worsening patient health.
Given the complexity surrounding sepsis, AI holds considerable promise in diagnosing the condition. Bobby Reddy, Jr., CEO and co-founder of Prenosis, stated, "AI is uniquely suited to tackle the complexities involved in sepsis diagnosis. By collecting the right data and applying AI technology, we can better determine the appropriate treatment paths for patients."
The Sepsis ImmunoScore, which integrates seamlessly into hospital electronic medical records, not only provides real-time critical information but also aids clinicians in efficiently acting on this data. This development represents a significant shift towards precision medicine, which accounts for the heterogeneous nature of sepsis.
Sinai Hospital first mobilized this AI tool clinically six weeks ago. Since its implementation, the tool has been used to assess or diagnose 75 patients. While immediate clinical care in the emergency department may not change dramatically, Corcoran noted that the tool enhances diagnostic accuracy for hospitalists assuming patient care afterward. Its ease of use encourages adoption without impeding workflow for healthcare providers.
LifeBridge Health plans to monitor several metrics, including compliance with the SEP-1 bundle—part of the Centers for Medicare and Medicaid Services guidelines related to severe sepsis management—while assessing the impact of this tool on length of stay, in-hospital mortality, and readmission rates.
Looking ahead, LifeBridge Health’s initiative is laying the groundwork for expanding the AI solution to its additional facilities. Prenosis is also focused on broadening its Immunix platform for conditions beyond sepsis, involving pneumonia, acute heart failure, and acute respiratory distress syndrome, among others.
As Prenosis builds its biobank spanning 11 hospitals with longitudinal specimens and clinical data from over 35,000 patients, it reveals distinct biological signatures that may aid in more targeted therapies for various acute conditions. Reddy emphasized, "We envision precision drugs being developed for a range of critical conditions, supported by AI-driven analysis that enhances our understanding of complex patient biology."
With rapid developments in AI and precision medicine, the potential to revamp the sepsis diagnostic landscape appears promising, setting the stage for transformative changes within healthcare over the next decade.
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