Sepsis ImmunoScore

by Prenosis  · Based in United States → — Enabling precision medicine in acute care
Critical Care Emergency Medicine Hospital Medicine
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Enterprise subscription model
Regulatory Status Disclosed

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
Sepsis ImmunoScore is supported by FDA-reviewed data and peer-reviewed studies. It was developed using Prenosis' Immunix™ platform, which facilitates precision medicine in acute care, and trained on a proprietary biobank and dataset of over 113,000 blood samples from more than 28,000 patients. The tool integrates up to 22 objective patient parameters, including demographics, vital signs, hematology and chemistry values, and sepsis biomarkers like PCT and CRP.
Clinical Validation Studies
A study published in *New England Journal of Medicine AI* (NEJM AI) validated the Sepsis ImmunoScore's high accuracy in diagnosing sepsis and predicting adverse patient outcomes, including in-hospital mortality, length of stay, ICU admission, need for mechanical ventilation, and vasopressor use. In a multicenter observational study involving 6,027 adult patients across 7 U.S. hospital sites, the Sepsis ImmunoScore demonstrated statistically superior performance compared to six conventional clinical scores and biomarkers (SOFA, PCT, CRP, SIRS, NEWS, and qSOFA) for predicting sepsis diagnosis, in-hospital mortality, and ICU admission. For sepsis prediction, it achieved an AUC of 0.82, outperforming SOFA (0.72), PCT (0.70), CRP (0.61), SIRS (0.59), NEWS (0.69), and qSOFA (0.67). For in-hospital mortality, the AUC was 0.80, surpassing SOFA (0.72), PCT (0.67), CRP (0.58), SIRS (0.60), NEWS (0.72), and qSOFA (0.69). For ICU admission, the AUC was 0.74, superior to SOFA (0.63), PCT (0.64), CRP (0.54), SIRS (0.60), NEWS (0.70), and qSOFA (0.65). A prospective observational study across three U.S. health systems showed that combining provider assessment with Sepsis ImmunoScore achieved an AUROC of 0.83 for sepsis risk prediction, compared to 0.68 for providers alone, demonstrating a 15% higher accuracy. The study also indicated that the use of Sepsis ImmunoScore reduced the risk of missed sepsis by lowering the rate of septic patients misclassified as low risk.
Alert Fatigue Management
The Sepsis ImmunoScore is designed as a clinician-ordered diagnostic test, rather than a passive, population-wide screening tool that continuously generates alerts. This approach aims to reduce false positives and alert fatigue often associated with continuous background monitoring AI systems. It can complement existing alert systems by providing patient-specific results to support decision-making for patients flagged by background alerts.
Differential Diagnosis Support
The Sepsis ImmunoScore can aid in differential diagnosis and clinical decision-making when the clinical picture is unclear. For patients with signs of severe illness, a low likelihood of sepsis result may direct clinicians to investigate alternative explanations for symptoms.
Clinical Workflow Integration
The Sepsis ImmunoScore is designed for direct integration into a hospital's Electronic Health Record (EHR) system. It functions like a diagnostic test that can be ordered by the treating clinician within the EHR. The software evaluates up to 22 clinical and laboratory measurements directly within the EHR, guiding decision-making without adding extra steps for clinicians. The results are displayed within the routine workflow alongside standard laboratory results and physical evaluations.
Decision Audit Trail
The Sepsis ImmunoScore provides a digital audit trail that documents the basis of its risk assessment. Each result is accompanied by an intuitive display that explains how each of the 22 patient parameters influenced the individual patient's sepsis risk.
Physician Tip

The Sepsis ImmunoScore is an FDA-authorized AI diagnostic tool that provides a quantitative risk score and categorizes patients into four risk levels (low, medium, high, very high) for having or developing sepsis within 24 hours. It integrates up to 22 parameters from the EHR, including vital signs, lab data, and sepsis-specific biomarkers. Utilize this tool alongside your clinical assessments and other laboratory findings; it is not intended to replace clinical judgment. The transparent display of how each parameter contributes to the score can help build trust and understanding of the AI's recommendations. Consider using the Sepsis ImmunoScore to enhance early identification and risk stratification, especially in cases where the clinical picture is unclear or to confirm your judgment. This can lead to more timely interventions and potentially improved patient outcomes.

The Sepsis ImmunoScore is designed for direct integration into existing Electronic Health Record (EHR) systems, allowing it to embed seamlessly into clinical workflows. It functions as a clinician-ordered test, with results accessible within the patient's EHR. The system uses up to 22 parameters pulled directly from the EHR, eliminating the need for new equipment or specialized training. This integration aims to provide actionable insights without creating additional steps or alert fatigue for clinicians.

Details

Category Clinical Decision Support & Reference, Triage & ER/ICU AI
Pricing Enterprise subscription model
DeploymentIntegrated into hospital EHR/EMR systems
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Hospital Medicine

What the Web Says

Sepsis ImmunoScore by Prenosis is an FDA-authorized AI/ML-based software that helps identify patients at risk for having or developing sepsis within 24 hours. It analyzes up to 22 parameters from a patient's electronic health record (EHR) to generate a quantitative risk score and assign patients to one of four risk categories. The tool is intended to be used in conjunction with other clinical assessments and not as a sole diagnostic factor.

Overall: Positive

Strengths

  • First FDA-authorized AI diagnostic tool for sepsis.
  • Utilizes AI to analyze up to 22 health metrics for early sepsis detection and outcome prediction.
  • Aids in predicting critical outcomes such as in-hospital mortality, ICU admission, mechanical ventilation, and length of stay.
  • Integrates directly with hospital EMRs for seamless workflow.
  • Potential to reduce antibiotic overprescription and improve compliance with sepsis care bundles.
  • Provides patient-specific risk assessment, accounting for the heterogeneity of sepsis.

Limitations

  • Limited accessible review coverage on traditional software review platforms like G2 and Capterra.
  • Not intended to be used as the sole basis for determining sepsis presence or risk.
  • Requires specific lab biomarkers to be available with suitable turnaround times for optimal clinical utility.
  • Not intended to replace clinical judgment or existing sepsis protocols.
  • Publicly available materials do not clearly document SOC 2/ISO certifications, which may be a barrier for some procurement processes.
  • Some studies on AI sepsis prediction models have shown limitations, including false positives and inconsistent performance across different hospital settings.

Based on reviews from: prenosis.com, fda.gov, time.com, beckershospitalreview.com, healthcarenowradio.com, medpath.com, reddit.com, precedenceresearch.com, physicianaitools.com, airframe.ai, g2intelligence.com, herald-review.com, tentelemed.com, ovid.com, captodayonline.com, illinois.edu, intuitionlabs.ai, nih.gov, substack.com, frontiersin.org

Last updated: 2026-10-31

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Press & Coverage

prenosis.com
Prenosis and Carle Health Mark Sepsis ImmunoScore® Clinical Deployment and First Patients Enrolled in OBSERVE-ARDS Clinical Study
Prenosis announced three milestones in its relationship with Carle Health: the clinical deployment of Sepsis ImmunoScore®, Carle Health becoming the first active site, and the enrollment of the first patients in Prenosis' OBSERVE-ARDS study. Sepsis ImmunoScore analyzes 22 parameters to help clinicians identify patients at risk of having or developing sepsis within 24 hours.
2026-10
lifebridgehealth.org
Sinai Hospital begins using first FDA-authorized AI diagnostic tool for sepsis
Sinai Hospital is now utilizing Sepsis ImmunoScore®, the first FDA-authorized AI diagnostic tool for sepsis, to help physicians identify at-risk patients earlier. The tool analyzes up to 22 clinical and laboratory measurements to detect patterns indicating sepsis risk within 24 hours.
2026-09
fiercehealthcare.com
LifeBridge Health deploys Prenosis' FDA-authorized AI tool to speed sepsis detection
LifeBridge Health's Sinai Hospital of Baltimore has implemented Prenosis' Sepsis ImmunoScore, an AI-powered tool that analyzes 22 parameters to detect early signs of sepsis or its progression within 24 hours. This tool received the FDA's first authorization for sepsis diagnostic software in 2024.
2026-07
prnewswire.com
Prenosis Announces Completion of Series A Financing Round and BARDA Contract Award
Prenosis announced the completion of its Series A financing round and a contract from BARDA, with combined funding supporting the commercial delivery of Sepsis ImmunoScore®, the first FDA-authorized AI diagnostic tool for sepsis. This funding will also advance the development of a comprehensive precision medicine platform for critical care applications.
2026-01
nih.gov
Longitudinal Prognostic Value of the Sepsis ImmunoScore for Predicting In-Hospital Mortality: A Multicenter Observational Study
This prospective multicenter U.S. study found that the Sepsis ImmunoScore predicts patient survival over time and outperforms available alternatives, indicating its prognostic association for monitoring patients. The study investigated the longitudinal prognostic value of the Sepsis ImmunoScore for predicting in-hospital mortality in patients at risk of infection across all hospital settings.
2025-10
prenosis.com
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
A new study published in the New England Journal of Medicine AI (NEJM AI) concluded that the Sepsis ImmunoScore™, the first FDA-authorized AI diagnostic for sepsis, has high accuracy for diagnosis and prediction of key adverse patient outcomes. This represents the first time an FDA-authorized tool for sepsis can predict all of these critical outcomes simultaneously.
2024-12
prenosis.com
Prenosis Announces FDA De Novo Marketing Authorization of the Sepsis ImmunoScoreTM
Prenosis, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Sepsis ImmunoScoreTM using the De Novo pathway, making it the first-ever FDA-authorized AI diagnostic tool for sepsis. The Sepsis ImmunoScoreTM is an AI/ML software as a medical device (AI SaMD) designed to guide rapid diagnosis and prediction of sepsis.
2024-04
netchoice.org
FDA Authorizes First AI-Driven System to Predict Sepsis
The FDA approved the first-ever AI-driven system, Prenosis' Sepsis ImmunoScore, designed to predict sepsis, a life-threatening response to infection. This advancement allows for earlier detection and intervention, potentially saving lives.
2024-04

Videos

Product demos, reviews, and walkthroughs for Sepsis ImmunoScore.

View all on YouTube

Frequently Asked Questions

Sepsis ImmunoScore is designed for seamless integration directly into a hospital's existing Electronic Health Record (EHR) system. It utilizes up to 22 parameters from the EHR, including vital signs, routine labs, and biomarkers, to generate a sepsis risk score and assign patients to one of four risk categories. This allows clinicians to view results within their routine workflow alongside other patient data, without requiring new equipment or specialized training.
Sepsis ImmunoScore is supported by FDA-reviewed data and peer-reviewed studies. It has demonstrated statistically superior performance in predicting sepsis diagnosis, in-hospital mortality, and ICU admission compared to conventional tools like SOFA, PCT, CRP, SIRS, NEWS, and qSOFA.
Sepsis ImmunoScore is intended to be used in conjunction with other laboratory findings and clinical assessments, not as the sole basis for determining the presence of sepsis or risk of progression. It is authorized for adult patients (18 and above) and has not been validated for use in specific inpatient settings like ICU or Labor and Delivery units. The score indicates risk but should not be interpreted as a direct probability percentage.
Sepsis ImmunoScore is an FDA-authorized diagnostic tool, distinguishing it from many early warning systems that primarily function as alert tools. While early warning systems passively monitor for signs of deterioration, Sepsis ImmunoScore actively engages providers when sepsis is suspected to support diagnostic and treatment decisions by providing a quantitative, individualized risk score.
Sepsis ImmunoScore operates on an enterprise subscription pricing model, which varies depending on the size and specific needs of each client. The product is sold to hospitals and health systems through an exclusive distribution partnership with Roche Diagnostics.

Compare Sepsis ImmunoScore

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-19 | First Added: 2026-04-19

Investors who backed Sepsis ImmunoScore

Funded through the company that built this tool.

Pace Ventures
VC T3
Berlin, Germany
$250k-$1M
Pace Ventures is a smaller venture firm with website and LinkedIn presence but no disclosed healthcare thesis, sub-vertical focus, AI angle, stage…
AI/ML in Healthcare Biotech
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