The FDA has approved a groundbreaking AI tool, Sepsis ImmunoScore™, for detecting sepsis, with Mercy’s vital data contribution. The tool’s development by Prenosis, Inc. and Mercy’s involvement showcase a significant leap in medical technology aimed at saving lives by early sepsis detection.
FDA Authorises AI Tool for Sepsis Detection, Supported by Mercy Data
ST. LOUIS, June 28, 2024 — A significant stride in medical technology was marked today as the U.S. Food and Drug Administration (FDA) authorised a pioneering tool called Sepsis ImmunoScore™. Developed by Prenosis, Inc., this artificial intelligence-driven tool aims to identify sepsis, a potentially fatal response to infection that is often challenging to diagnose. Mercy, a prominent health care system, contributed to the tool’s development as one of ten national study sites.
Sepsis remains a grave medical concern, affecting 1.7 million adults in the United States each year. The Centers for Disease Control and Prevention (CDC) notes that one in three patients who die in hospitals had sepsis during their stay, underlining the critical need for early detection methods.
Dr. Ashok Palagiri, Vice President of Mercy Virtual inpatient services, emphasised the significance of swift sepsis detection. “We know how dangerous sepsis can be, and having tools to detect it quickly is crucial,” Dr. Palagiri stated. “This clinical trial and research are essential in spotting sepsis early. We are grateful to have contributed to this research and we’re hopeful this tool will save lives.”
Mercy Research played a pivotal role in the development of Sepsis ImmunoScore™ by providing 30,000 blood samples since 2019. These samples, initially earmarked for disposal, were repurposed for testing the tool’s efficacy. Prenosis used these samples to refine the tool’s ability to analyse a patient’s immune response to infection.
The Sepsis ImmunoScore™ evaluates 22 different factors to generate a risk score and category. This score is then integrated into the hospital’s electronic health records, making it readily accessible to healthcare providers. The tool also offers insights into how each evaluated factor influences the final score, thereby providing a transparent and understandable basis for decision-making by the patient care team.
Mercy, recognised as one of the top health systems in the United States, played an instrumental role in the clinical trials. With over 50 hospitals and an extensive network of outpatient facilities and specialist care units across multiple states, Mercy’s involvement brought substantial credibility and robust data to the study.
The Sepsis ImmunoScore™ will potentially transform how healthcare providers identify and respond to sepsis, leading to faster intervention and improved patient outcomes. Given the current statistics and the urgency surrounding sepsis diagnosis, this tool arrives at a crucial juncture in medical practice.
In fiscal year 2023, Mercy demonstrated its commitment to community well-being by providing over half a billion dollars in charity care and other community benefits. Their extensive efforts underscore not only a dedication to patient care but also a commitment to integrating advanced technologies such as the Sepsis ImmunoScore™ to enhance clinical outcomes.
As artificial intelligence continues to permeate the medical field, the approval of the Sepsis ImmunoScore™ could set a precedent for future innovations aimed at combating complex and life-threatening conditions. With this FDA authorisation, the tool is poised to make a significant impact on sepsis treatment protocols nationwide.
Today’s announcement marks not only a milestone for Prenosis and Mercy but also represents a promising advancement in the ongoing battle against sepsis. The integration of AI in healthcare to address such critical conditions reflects a growing trend towards technology-driven solutions in medicine, offering hope for better patient care and reduced mortality rates.
Mercy’s contribution to this FDA-approved tool underscores the importance of collaboration between healthcare institutions and technology developers, aiming for the common goal of improving patient outcomes and saving lives. The Sepsis ImmunoScore™ stands as a testament to what can be achieved through such partnerships, heralding a new era in sepsis detection and treatment.
