ABSTRACT
Sepsis ImmunoScore™ is the first FDA-authorized AI/ML-based blood test for real-time risk stratification of sepsis, approved via the De Novo pathway in 2024. Built on a dataset of over 45,000 hospitalizations, the algorithm utilizes 22 routinely available clinical and laboratory parameters and operates fully autonomously within hospital IT systems. In a prospective validation across U.S. hospitals, it demonstrated robust predictive performance with an AUC-ROC of 0.84 for sepsis identification and 0.85 for forecasting 24-hour clinical deterioration. Compared to Epic Sepsis Model and qSOFA, ImmunoScore™ showed superior accuracy, reduced false positives, and eliminated the need for manual confirmation. The tool assigns patients to one of four color-coded risk tiers and translates outputs into actionable mortality risk. Clinical integration in over 200 hospitals resulted in a 1-hour reduction in time-to-antibiotics and a 17-point improvement in SEP-1 compliance. Ongoing randomized trials aim to assess its impact on clinical outcomes when used to guide early goal-directed therapy. ImmunoScore™ represents a paradigm shift by combining diagnostics and prognostics into a single, interpretable score, enabling earlier, personalized, and scalable sepsis care.
References
- [1] DEN230036 – Sepsis ImmunoScore De Novo Decision Summary. 2024.
- [2] Reddy B, et al. FDA-Authorized AI/ML Tool for Sepsis Prediction: Development and Validation of the Sepsis ImmunoScore. N Engl J Med AI. 2024.
- [3] MedTech Dive. FDA grants de novo nod to AI tool for detecting sepsis. 2024.
- [4] Prenosis Inc. Sepsis ImmunoScore™ named a TIME Best Invention of 2024. 2024.
- [5] Bashir R, Reddy B Jr, Patel S, et al. Development and Validation of the First FDA-Authorized Artificial Intelligence Tool for Sepsis (Sepsis ImmunoScore). May 6, 2024; 2024.05.06.24306954. doi:10.1101/2024.05.06.24306954.
- [6] Wong A et al. External Validation of the Epic Sepsis Model. JAMA Intern Med. 2021.
- [7] Machado FR et al. Prognostic accuracy of qSOFA: meta-analysis. Crit Care. 2023.
- [8] Prenosis Inc. AI as a provider-support tool: enhancing sepsis diagnosis and SEP-1 bundle compliance [press release]. Chicago (IL): Prenosis; 20 Feb 2024
- [9] Roche Diagnostics; Prenosis Inc. Prenosis announces commercial distribution collaboration with Roche for Sepsis ImmunoScore™ on the navify® Algorithm Suite [press release]. Indianapolis (IN): Roche Diagnostics; 12 Apr 2024.
- gov. PRECISE-I: Prospective RCT of Sepsis ImmunoScore-guided therapy (NCT05784526). 2024.
- Prenosis Inc. Sepsis ImmunoScore™ to integrate with PathogenID NxGen rapid metagenomics [press release]. 15 Jan 2025.
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