Study published in the New England Journal of Medicine AI Concludes that the Sepsis ImmunoScore™, the First FDA-Authorized AI Tool for Sepsis, has both significant Diagnostic and Predictive Power
Groundbreaking NEJM AI Study Highlights the Ability of Prenosis’ Sepsis ImmunoScore™ to Holistically Predict Adverse Outcomes, Ushering in a New Era of Predictive Sepsis Tools Powered by AI
CHICAGO, Dec. 4, 2024 /PRNewswire/ — A new study published in the New England Journal of Medicine AI (NEJM AI) concluded the Sepsis ImmunoScore™, the first FDA-authorized AI diagnostic for sepsis, has high accuracy for the diagnosis of sepsis and for prediction of key adverse patient outcomes, concretely demonstrating the benefit of AI to inform sepsis care. Sepsis, an overactive immune response to infection, costs the U.S. healthcare system billions of dollars annually and claims the lives of at least 350,000 people each year—more than all cancers combined.
The peer-reviewed study—FDA-Authorized AI/ML Tool for Sepsis Prediction: Development and Validation—found the Sepsis ImmunoScore™ has high accuracy for sepsis diagnosis and simultaneously predicted critical outcomes, including mortality during hospitalization, length of stay before discharge, ICU admission, need for mechanical ventilation, and use of vasopressors. This represents the first time an FDA-authorized tool for sepsis can predict all of these critical outcomes simultaneously.
This milestone publication underscores the potential of Prenosis Inc.’s Sepsis ImmunoScore™ to transform sepsis management by presenting providers with trustworthy predictive information, allowing them to shift from a reactive to a proactive approach to care.
While single biomarkers, such as Procalcitonin (PCT), have been valuable tools in diagnosing sepsis for over two decades, they have limitations when trying to predict the future. The study demonstrated the combination of multidimensional inputs—vital signs, lab data, and sepsis-specific biomarkers—into a comprehensive AI-driven tool provides more reliable diagnostic information and is predictive of future patient outcomes.
“The Sepsis ImmunoScore™ is the first FDA-authorized sepsis AI algorithm that functions by embedding in the EMR and is approved to aid providers in the identification and assessment of patients with sepsis,” said Nathan I. Shapiro, MD, MPH, a Professor of Emergency Medicine at Harvard Medical School and attending physician in the Department of Emergency Medicine at Beth Israel Deaconess Medical Center, and the paper’s corresponding author1.
“For too long, clinicians have struggled with the early and accurate prediction of adverse outcomes due to sepsis, a complex, rapidly progressing condition,” said Bobby Reddy, Jr., Prenosis Co-Founder and CEO. “By delivering FDA validated AI results with transparency and explainability for clinicians, tools like the Sepsis ImmunoScore™ offer critical insights to improve patient outcomes.”
“Hospitals and clinicians now have access to the first-ever FDA-authorized, peer-reviewed AI solution that provides unmatched insights into sepsis risk and prediction of the negative outcomes associated with sepsis,” said Akhil Bhargava, the study’s lead author. “This study confirmed that AI, when validated, can be a reliable, comprehensive tool to assist providers with identification of patients at high risk of sepsis and prediction of sepsis-related adverse outcomes,” added Bhargava, Prenosis’ Senior Data Scientist — Applied Machine Learning.
About the Sepsis ImmunoScore™
FDA-authorized via the De Novo pathway in April 2024, the Sepsis ImmunoScore™ outputs a combination of both diagnostic and predictive information previously unavailable in a legally marketed device for sepsis. Unlike early warning systems that alert clinicians to potential sepsis with high amounts of false positives, leading to alert fatigue, the Sepsis ImmunoScore™ delivers actionable and trustworthy insights. The Sepsis ImmunoScore™ works in concert with a clinician’s suspicion of serious infection, providing information exactly when needed for decision-making.
The Sepsis ImmunoScore™ was built using Prenosis’ Immunix™ platform, which enables precision medicine in acute care. Immunix™ facilitates the development and validation of new precision solutions, such as AI biomarkers, and their real-time implementation. Over a decade of collaboration with more than ten U.S. partner hospitals, Prenosis used Immunix™ to build a proprietary biobank and dataset of over 113,000 blood samples from more than 28,000 patients. Prenosis merges biological data extracted from these samples with clinical information from Electronic Medical Records, creating the world’s largest biological-clinical dataset for acute care patients with suspected serious infections. This dataset enables the development of AI algorithms to detect rapid immune responses and recommend personalized therapies in real time in hospitals and emergency departments.
About Prenosis
Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. We believe healthcare should be tailored to individual biology. Our data-driven approach to fast-moving biology in acute care is ushering in a new era of precision medicine. Powered by our Immunix™ precision medicine platform, we generate proprietary biological insights that drive the development of precision products and enable real-time delivery of optimal therapy. With Immunix™, we created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore™.
For more information, visit: www.prenosis.com
1 Disclosure: Shapiro holds private equity in and consults for Prenosis.
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