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Sepsis ImmunoScore

by Prenosis · Based in United States → — Enabling precision medicine in acute care

Critical Care Emergency Medicine Hospital Medicine

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Overview

The Sepsis ImmunoScore by Prenosis is the first-ever AI diagnostic tool to receive marketing authorization from the U.S. Food and Drug Administration (FDA) for sepsis. This artificial intelligence/machine learning software as a medical device (AI SaMD) is designed to guide rapid diagnosis and prediction of sepsis and adverse outcomes in acute care settings.

The tool holistically evaluates a patient’s biological status by analyzing up to 22 diverse parameters, including biomarkers, vital signs, and clinical data, directly from the patient’s Electronic Health Record (EHR). It generates a risk score and assigns the patient to one of four discrete risk stratification categories, correlating to their risk of deterioration, such as length of stay, in-hospital mortality, ICU admission, mechanical ventilation, and/or vasopressor use within 24 hours.

Integrated directly into hospital EMR/EHR systems, the Sepsis ImmunoScore provides an intuitive display that transparently explains how each patient parameter contributed to the final sepsis score, fostering clinician trust and a true clinician-AI partnership. Built on Prenosis’ proprietary Immunix™ precision medicine platform, the Sepsis ImmunoScore is not an alert system but a diagnostic and predictive tool aimed at enabling earlier, more accurate sepsis diagnosis, faster treatment decisions, improved patient outcomes, and enhanced compliance with payer protocols like the CMS SEP-1 bundle.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

First FDA-authorized AI diagnostic for sepsis
AI/ML Software as a Medical Device (SaMD)
Guides rapid diagnosis and prediction of sepsis
Leverages 22 diverse parameters (biomarkers and clinical data)
Outputs a risk score and four discrete risk categories
Predicts risk of deterioration (length of stay, in-hospital mortality, ICU admission, mechanical ventilation, vasopressor use) within 24 hours
Integrated directly into hospital Electronic Medical Records (EMR/EHR)
Intuitive display explains how parameters contribute to the score (transparency)
Built on Prenosis' Immunixu2122 precision medicine platform
Diagnostic tool, not an alert system

Use Cases

Earlier and more accurate sepsis diagnosis
Risk stratification for patients in acute care settings
Faster treatment decisions and improved patient outcomes
Improve compliance with payer protocols (e.g., CMS SEP-1 bundle)
Reduce hospital length of stay and healthcare costs
Augment clinician decision-making with individualized, integrated diagnostics

What Physicians Need to Know

Evidence Base

FDA De Novo Authorized (April 2024) as the first AI diagnostic tool for sepsis. Built on a proprietary biobank and dataset of over 113,000 blood samples from more than 28,000 patients, combining deep biological and broad clinical data. Utilizes 22 holistic parameters, including vital signs, lab data, and sepsis-specific biomarkers.

Clinical Validation Studies

A study published in the New England Journal of Medicine AI (NEJM AI) in December 2024 concluded high accuracy for sepsis diagnosis and prediction of critical outcomes. A multicenter observational cohort study of 6,027 patients demonstrated statistically superior performance compared to conventional clinical scores (SOFA, qSOFA, SIRS, NEWS) and biomarkers (PCT, CRP) in predicting sepsis diagnosis, ICU admission, and in-hospital mortality. Achieved an AUC of 0.84 for sepsis identification and 0.85 for forecasting 24-hour clinical deterioration in prospective validation across U.S. hospitals. Predicts in-hospital mortality, hospital length of stay, ICU transfer, vasopressor use, and mechanical ventilation within 24 hours. A human factors study with over 30 clinicians reported 100% agreement that the graphical interface built trust in the tool.

Alert Fatigue Management

Designed as a diagnostic integrated into the workflow, rather than an alert system. It delivers actionable and trustworthy insights, contrasting with early warning systems that often produce high false positives leading to alert fatigue. The tool works in concert with clinician suspicion, providing information precisely when needed for decision-making. Results are presented in four color-coded risk categories.

Differential Diagnosis Support

Aids in identifying patients at risk for having or developing sepsis and stratifies them into four discrete risk categories. Provides an objective assessment of patients at elevated risk for sepsis or progression within 24 hours. While primarily focused on sepsis risk, its predictive power for critical outcomes like ICU admission and mortality supports broader considerations for severe illness.

Clinical Workflow Integration

Designed for seamless, EMR-agnostic integration directly into existing hospital EHR/EMR systems. Can be configured to order the ImmunoScore upon early warning system activation or directly through the EMR. 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. Features an intuitive display that transparently explains how each of the 22 patient parameters contributed to the risk score, fostering clinician trust.

Decision Audit Trail

Offers transparency by providing an intuitive display that directly explains how each of the 22 patient parameters either increased or decreased the risk of sepsis for that individual patient. This inherent explainability supports understanding the AI's reasoning and fosters a 'clinician-AI partnership,' avoiding a 'black box' approach.

Physician Tip

The Sepsis ImmunoScore is an adjunctive tool, not a standalone diagnostic; always integrate its insights with your clinical judgment and other findings. Leverage its transparent explanation of risk factors to better understand individual patient trajectories and communicate risk to care teams. Consider its predictive power for adverse outcomes to proactively manage high-risk patients, potentially reducing time to intervention and improving SEP-1 compliance. Remember it's designed to augment, not replace, your decision-making, and its output is a risk score, not a probability.

The Sepsis ImmunoScore is built for seamless integration into existing EHR/EMR systems, supporting various configurations for ordering and result display. It is EMR-agnostic and complements current sepsis protocols. The tool operates autonomously within hospital IT systems and is available on platforms like Roche's navify Algorithm Suite. Future integrations may leverage FHIR backend platforms for enhanced data exchange.

At a glance

Pricing Enterprise subscription model

Deployment Integrated Into Hospital EHR/EMR Systems

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Details

Category	Clinical Decision Support & Reference, Triage & ER/ICU AI
Pricing	Enterprise subscription model Subscription pricing varies depending on the size and needs of each client; sold through an exclusive distribution partnership with Roche Diagnostics
Deployment	Integrated into hospital EHR/EMR systems
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated The Sepsis ImmunoScore™ received FDA De Novo marketing authorization in April 2024 as the first-ever AI diagnostic tool for sepsis. It is an AI/ML software as a medical device (SaMD) intended to aid healthcare providers in the risk assessment for the presence of or progression to sepsis within 24 hours of patient assessment in the Emergency Department or hospital.
Integrations
EHR	Not specified
Specialties	Critical Care, Emergency Medicine, Hospital Medicine

What the Web Says

The Sepsis ImmunoScore, developed by Prenosis, is the first FDA-authorized AI diagnostic tool for sepsis, designed to aid in early detection and risk assessment within 24 hours of hospital admission. It utilizes 22 parameters from electronic health records, including vital signs, lab data, and biomarkers, to generate a risk score and categorize patients into four discrete risk groups. The tool aims to improve patient outcomes by enabling faster treatment decisions and reducing antibiotic overprescription.

Overall: Positive

Strengths

First FDA-authorized AI diagnostic for sepsis.
Aids in early detection and risk prediction of sepsis within 24 hours.
Utilizes 22 holistic parameters for a comprehensive patient assessment.
Demonstrates superior predictive performance compared to conventional sepsis tools like SOFA, PCT, and CRP.
Integrates with existing Electronic Medical Record (EMR) systems for seamless workflow.
Provides transparency by explaining how each parameter contributes to the risk score, building clinician trust.

Limitations

Not intended to be used as the sole basis for sepsis diagnosis or risk assessment.
Not a continuous monitoring or alert system.
Has not been validated for use in specific inpatient settings like ICU or Labor and Delivery units.
Some general skepticism on Reddit regarding the accuracy and real-world impact of AI sepsis prediction tools.
The sales cycle for healthcare AI solutions can be long (18-24 months).
Other companies and institutions have also developed sepsis detection tools, with varying success.

Based on reviews from: G2 Intelligence, Becker's Hospital Review, TIME, Prenosis (prenosis.com), medRxiv, MDPI, Labcorp, navifyu00ae Algorithms, Reddit, MarkTechPost, MedTech Dive, AI's Transformative Power: FDA Approves First Ever AI System to Help Identify Sepsis Early, HealthcareNOWradio.com, European Society of Medicine, CMRubinWorld, YouTube

Last updated: 2026-07-19

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Press & Coverage

Prenosis (via PR Newswire)

Prenosis Announces FDA De Novo Marketing Authorization of the Sepsis ImmunoScore TM

Prenosis announced that the FDA granted marketing authorization for its Sepsis ImmunoScoreu2122, the first-ever AI diagnostic tool for sepsis, using the De Novo pathway. This AI/machine learning software as a medical device (AI SaMD) guides rapid diagnosis and prediction of sepsis within 24 hours.

2024-04

CNBC

FDA authorizes Prenosis software as first AI tool that can diagnose sepsis

CNBC reported on Prenosis receiving FDA approval for its Sepsis ImmunoScore, highlighting it as the first AI-powered diagnostic tool for sepsis. The article explains how the tool uses 22 parameters to assess a patient's sepsis risk and was approved through the FDA's De Novo pathway.

2024-04

MedTech Dive

FDA grants de novo nod to AI tool for detecting sepsis

MedTech Dive covered the FDA's de novo clearance of Prenosis' Sepsis ImmunoScore, noting it's the first such AI tool for sepsis diagnosis and prediction. The software provides a risk score based on 22 parameters and is integrated into electronic health records.

2024-04

Prenosis (via PR Newswire)

Prenosis Announces Commercial Distribution Collaboration with Roche for Sepsis ImmunoScoreu2122

Prenosis announced a commercial distribution collaboration with Roche for its Sepsis ImmunoScoreu2122, making the FDA De Novo authorized AI diagnostic tool available on Roche's navifyu00ae Algorithm Suite. This partnership aims to bring the tool to hospitals across the United States.

2024-04

U.S. Food and Drug Administration (FDA)

FDA Roundup: April 5, 2024

The FDA included the authorization of Prenosis, Inc.'s Sepsis ImmunoScore in its April 5, 2024 roundup, highlighting it as an AI/Machine Learning-Based Software that identifies patients at risk for having or developing sepsis. The FDA emphasized the importance of such technologies in preventing this serious condition.

2024-04

Prenosis

Sepsis ImmunoScoreu2122 Named a TIME Best Invention of 2024

Prenosis announced that its Sepsis ImmunoScoreu2122 was named one of TIME's Best Inventions of 2024, recognizing it as the first FDA-authorized AI diagnostic and predictive tool for sepsis. The award acknowledges its role in transforming how healthcare providers anticipate, diagnose, and treat sepsis.

2024-10

Prenosis (via PR Newswire)

Study published in the New England Journal of Medicine AI Concludes that the Sepsis ImmunoScoreu2122, the First FDA-Authorized AI Tool for Sepsis, has both significant Diagnostic and Predictive Power

A study published in the New England Journal of Medicine AI (NEJM AI) concluded that the Sepsis ImmunoScoreu2122 has high accuracy for sepsis diagnosis and prediction of adverse patient outcomes. This peer-reviewed study highlights the tool's diagnostic and prognostic capabilities.

2024-12

Diagnostics World News

Sepsis AI Tool Validated for Both Diagnostic, Prognostic Use

Diagnostics World News reported on the NEJM AI study, confirming the Sepsis ImmunoScore's high accuracy for sepsis diagnosis and prediction of adverse patient outcomes. The article emphasizes the tool's ability to provide both diagnostic and prognostic power.

2024-12

Videos

Product demos, reviews, and walkthroughs for Sepsis ImmunoScore.

Prenosis: AI in Healthcare

Prenosis

Prenosis - Overview

MedTech Innovator

Why Sepsis Is Hard to Diagnose | NewsNation Interview

Prenosis

Why Sepsis Still Gets Missed and How Prenosis Is Narrowing the Signal

Healthcare IT Today

Prenosis: Finalist for 2022 Hearst Health Prize

Hearst

How AI Is Transforming Sepsis Detection | Fox Business Interview

Prenosis

View all on YouTube

Frequently Asked Questions

How is the Sepsis ImmunoScore intended to be used in clinical decision support for sepsis patients?

The Sepsis ImmunoScore is an FDA-authorized AI diagnostic tool that analyzes up to 22 parameters from a patient's Electronic Health Record (EHR) to generate a risk score and stratify them into four categories for sepsis presence or progression within 24 hours. It aids in identifying patients at risk for sepsis, in-hospital mortality, ICU admission, mechanical ventilation, and vasopressor use, complementing other clinical assessments rather than serving as a sole diagnostic tool.

What are the key workflow considerations and potential challenges for integrating Sepsis ImmunoScore into existing sepsis management protocols?

The Sepsis ImmunoScore is designed for seamless integration into existing EHR/EMR systems, allowing it to be ordered upon early warning system activation or directly. This integration aims to complement current sepsis protocols and provide objective data without contributing to alert fatigue, though initial staff training and ensuring timely lab processing for the 22 parameters would be workflow considerations.

How does Sepsis ImmunoScore compare to traditional biomarkers or other methods currently used to assess immune status in sepsis?

Sepsis ImmunoScore has demonstrated superior predictive performance compared to traditional biomarkers and clinical scores such as SOFA, PCT, CRP, SIRS, NEWS, and qSOFA for sepsis diagnosis, in-hospital mortality, and ICU admission. Unlike general inflammatory markers, it provides a more comprehensive, personalized biological assessment by analyzing a multitude of inputs to offer a nuanced view of the patient's immune state.

What are the primary limitations of the Sepsis ImmunoScore, and in which clinical scenarios might its utility be diminished or misleading?

The Sepsis ImmunoScore should not be used as the sole basis for determining the presence or risk of sepsis. Its safety and effectiveness have not been evaluated in patients under 18 years of age, nor has it been validated for use in specific inpatient settings like ICU or Labor and Delivery units. Potential limitations also include generalizability to populations outside the study cohorts and possible misclassification due to EMR data extraction or ICD-10 codes.

What is the current evidence supporting the use of Sepsis ImmunoScore for improving patient outcomes, and what ongoing research is relevant?

Sepsis ImmunoScore is the first FDA-authorized AI diagnostic for sepsis, with studies published in journals like NEJM AI demonstrating high accuracy for sepsis diagnosis and prediction of critical outcomes such as mortality, ICU admission, and length of stay. Ongoing research focuses on further validating its impact on clinical decision-making and patient outcomes in diverse settings.

How do I interpret the Sepsis ImmunoScore results, and what actions should I take based on different scores?

The Sepsis ImmunoScore provides a risk score ranging from 0 to 100, categorizing patients into low, medium, high, or very high risk for sepsis or progression within 24 hours. The tool features an intuitive display that transparently explains how each of the 22 input parameters contributed to the individual patient's score, using SHAP values, to guide clinical interpretation and inform personalized treatment decisions.

What are the cost implications of implementing Sepsis ImmunoScore, and how does it factor into hospital budgeting and reimbursement?

Sepsis ImmunoScore operates on a subscription pricing model, with costs varying based on the client's size and needs, and is distributed through Roche Diagnostics. A new ICD-10-PCS code (XXEZXCB) became effective October 1, 2025, facilitating documentation for its clinical use and serving as a prerequisite step for New Technology Add-on Payment (NTAP) submissions, which can aid in reimbursement optimization for hospitals.

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