Sepsis ImmunoScore^®

Sepsis ImmunoScore is used alongside lab results and clinical evaluation to help assess a patient’s risk of sepsis or progression within 24 hours.

It is intended to be used:

• To support assessment of sepsis risk in patients admitted to the Emergency Department or hospital with suspected sepsis, as indicated by the order of a blood culture
• In conjunction with other laboratory findings, not as a replacement of clinical judgment
• By licensed healthcare providers

Sepsis ImmunoScore is intended for use in:

• Adult patients (18 years or older) admitted to the Emergency Department or hospital with suspected sepsis as indicated by the order of a blood culture

Sepsis ImmunoScore has not been validated for use in certain inpatient settings such as ICU or Labor and Delivery units.

The FDA, through its BEST (Biomarkers, EndpointS, and other Tools) Glossary developed with the NIH, defines a biomarker as:

“A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention (including therapeutic interventions).”

The FDA recognizes multiple categories of biomarkers, including Diagnostic, Prognostic, Predictive, Pharmacodynamic/Response, Monitoring, Safety, and Susceptibility/Risk.

Prenosis recognized the need for a new category: the AI-Biomarker.

An AI-Biomarker is:

“A defined, algorithm-derived characteristic generated through artificial intelligence or machine learning methods that integrate and analyze one or more data modalities (e.g., molecular, physiologic, imaging, electronic health record, or clinical data) to provide a reproducible measure indicative of normal biological processes, pathogenic processes, or responses to an exposure or intervention.”

Put more simply:

An AI biomarker is a computed biological signal that combines patterns across multiple types of patient data, such as:

• Clinical data
• Laboratory values
• Physiological measurements
• Other biomarkers

The result is a reproducible score that serves the same functions as a traditional biomarker—detecting disease, predicting outcomes, or assessing treatment response.

Sepsis ImmunoScore is currently approved and available solely in the United States. Additional markets are under exploration.

Sepsis ImmunoScore inputs up to 22 parameters from the electronic health record (EHR), calculates a sepsis risk score using a locked algorithm, and outputs the Sepsis Patient View, a screen that displays the risk score along with the contributing clinical parameters and their impact on the score.

The software integrates directly within the EHR for seamless workflow integration.

View our interactive demonstration to see how it works.

Sepsis ImmunoScore calculates a patient’s risk of sepsis and assigns it to one of four risk categories: low, medium, high, or very high risk.

Each category indicates a patient’s risk of having sepsis or developing sepsis within the next 24 hours.

These risk categories are highly correlated with clinical deterioration within 24 hours, including ICU admission, vasopressor use, mechanical ventilation, in-hospital mortality, and length of stay.

As a multi-band test, Sepsis ImmunoScore provides more actionable insight than a single positive/negative result.

Early warning systems function primarily as alert tools, while Sepsis ImmunoScore is an FDA-authorized diagnostic device. These approaches are fundamentally different.

Early warning systems passively monitor for signs of deterioration, whereas Sepsis ImmunoScore actively engages providers when sepsis is suspected to support diagnostic and treatment decisions.

Sepsis ImmunoScore combines up to 22 parameters from the EHR using a validated algorithm to deliver a quantitative, individualized risk score. When used alongside early warning systems, Sepsis ImmunoScore improves the identification of true sepsis patients and could reduce false alerts.

Because it does not rely on physical test kits or analyzers, is it not impacted by supply chain disruptions. And because it integrates seamlessly with the EHR, it can scale across an entire hospital or health system very quickly. Providers simply order it and view results like any other lab test, all within their existing clinical workflow.

For more information:
[link to Epic paper when done]
[link to comparators paper if/when published]

Yes, Sepsis ImmunoScore is a Software as Medical Device (SaMD), and the first and only FDA-authorized AI diagnostic tool for sepsis through the De Novo pathway.

Sepsis ImmunoScore is supported by clinical evidence, including FDA-reviewed data and peer-reviewed studies.

Two published studies include:

Bhargava A. et al. Validation of a Machine Learning Diagnostic Tool for the Prediction of Sepsis and Critical Illness. https://www.medrxiv.org/content/10.1101/2024.05.06.24306954v1.full-text

Bhargava A. et al. FDA-Authorized AI/ML Tool for Sepsis Prediction: Development and Validation. https://ai.nejm.org/doi/full/10.1056/AIoa2400867

A 2024 study published in the New England Journal of Medicine AI (NEJM AI) demonstrated strong diagnostic performance for identifying sepsis and predicting clinical deterioration.

The deployed Sepsis ImmunoScore algorithm is a locked model and does not perform continuous learning. This ensures consistent, validated performance across all clinical environments.

Prenosis maintains a robust post-implementation monitoring program of Sepsis ImmunoScore to evaluate model performance and detect potential algorithm drift. Ongoing review ensures continued accuracy and alignment with regulatory and clinical performance standards.

Data used to train and validate the AI/ML model comes from Prenosis’ proprietary dataset and biobank, comprised of de-identified data from multiple hospital sites, including:

• Prospectively collected clinical data (EHR data)
• Time-series biological samples
• Biomarker measurements

The dataset includes adult patients admitted to the Emergency Department or hospital with suspected sepsis, as defined by the first order of a blood culture.

Sepsis ImmunoScore delivers a clear risk score based on each patient’s individual biology to support clinical decision-making.

• Quantitative, biology-based risk stratification
  • Sepsis ImmunoScore combines up to 22 patient parameters to deliver a clear, quantitative score that helps clinicians quickly assess sepsis risk.
• Early prediction of adverse outcomes
  • The tool predicts sepsis onset and related outcomes, including ICU admission, mechanical ventilation, vasopressor use, in-hospital mortality, and length of stay.
• Support for guideline-aligned sepsis care
  • By identifying at-risk patients sooner, Sepsis ImmunoScore can help hospitals improve SEP-1 bundle performance, standardize sepsis management, and deliver faster, evidence-based intervention.

Sepsis ImmunoScore is currently included within the Diagnosis-Related Group (DRG) for sepsis, with no separate reimbursement.

However, as of October 1, 2025, a new ICD-10-PCS code became available for AI sepsis diagnostic tools, including Sepsis ImmunoScore.

For more information, review our Hospital Billing and Coding Guide.