Products

Sepsis ImmunoScore
Prenosis
Clinical Decision Support & Reference
Sepsis ImmunoScore by Prenosis is the first FDA-authorized AI diagnostic for sepsis, providing rapid risk assessment and prediction of adverse outcomes. It analyzes 22 parameters from EHRs to generate a risk score and four risk categories, aiding clinicians in faster treatment decisions and improved patient outcomes.

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About Prenosis

Prenosis is a biology-based technology company at the forefront of applying artificial intelligence and machine learning to revolutionize precision medicine in acute care. Their core mission is to move beyond a one-size-fits-all approach to healthcare by tailoring diagnostics and therapeutics to each patient’s unique biological profile. The company’s flagship product, Sepsis ImmunoScore®, is the first-ever FDA-authorized AI diagnostic tool for sepsis.

This innovative software as a medical device (AI SaMD) leverages a proprietary platform called Immunix™ to integrate deep biological data with extensive clinical data from a large biobank of over 100,000 blood samples and electronic medical records. The Sepsis ImmunoScore® analyzes up to 22 diverse parameters to holistically evaluate a patient’s biological status, providing a risk score and stratifying patients into four discrete risk categories for the presence of or progression to sepsis within 24 hours. This transparency in how the AI model calculates its score is crucial for building clinician trust and fostering a true clinician-AI partnership, enabling faster and more accurate treatment decisions, improved patient outcomes, and enhanced operational efficiency.

Beyond sepsis, Prenosis is expanding its focus to develop integrated diagnostic and therapeutic solutions for other critical acute care conditions. Their Immunix™ platform and evidence generation capabilities are being leveraged to create more diagnostic tools and AI-guided precision therapeutics for severe respiratory infections, including pneumonia and acute respiratory distress syndrome (ARDS), as well as exploring applications in heart failure and acute kidney injury.

What Physicians Need to Know

Specialization: Precision Medicine in Acute Care
Prenosis is an AI-powered precision medicine company focused on transforming the identification and treatment of serious infections, particularly sepsis, in acute care settings.
Flagship Product: Sepsis ImmunoScoreu2122
Their revolutionary AI diagnostic and predictive tool, the Sepsis ImmunoScoreu2122, received FDA De Novo marketing authorization in April 2024. It provides both diagnostic and predictive information for early sepsis detection and risk assessment.
Key Differentiator: First FDA-Authorized AI for Sepsis
The Sepsis ImmunoScoreu2122 is the first-ever AI diagnostic for sepsis to receive FDA marketing authorization, distinguishing it from other early warning systems.
Core Technology: Immunixu2122 Platform
The Sepsis ImmunoScoreu2122 was built using Prenosis' proprietary Immunixu2122 precision medicine platform, which enables the development and real-time implementation of precision medicine tools.
Data-Driven Approach
Prenosis leverages a proprietary biobank and dataset, built over a decade of collaboration with over ten U.S. partner hospitals, consisting of more than 100,000 blood samples from over 25,000 patients. This dataset is merged with extensive clinical data from Electronic Medical Records (EMRs).
Predictive Capabilities
The Sepsis ImmunoScoreu2122 has high accuracy for sepsis diagnosis and simultaneously predicts critical outcomes such as mortality during hospitalization, length of stay, ICU admission, need for mechanical ventilation, and use of vasopressors.
Physician Tip

For physicians, Prenosis' Sepsis ImmunoScoreu2122 offers actionable, trustworthy insights for early and accurate sepsis detection, moving from a reactive to a proactive approach in patient care. It integrates directly into existing EMR systems, providing a sepsis risk score and stratifying patients into four discrete risk categories based on up to 22 parameters from the patient's record (demographics, vitals, labs, sepsis biomarkers). A key benefit is its transparency, revealing how individual patient parameters contribute to the score, fostering trust and enabling a true clinician-AI partnership. This tool aims to reduce alert fatigue associated with less precise early warning systems and supports clinical decision-making to improve patient outcomes, reduce hospital length of stay, and potentially decrease healthcare costs.

The Sepsis ImmunoScoreu2122 software is designed for direct integration into hospital Electronic Medical Records (EMRs), making it easily accessible within existing clinical workflows. It operates as a cloud-based system and utilizes the Aidbox FHIR Platform for an EHR-independent data store, ensuring robust security features, including HIPAA compliance and high availability.

Products by Prenosis

1 product in the directory

Sepsis ImmunoScore
Prenosis
Clinical Decision Support & Reference
Sepsis ImmunoScore by Prenosis is the first FDA-authorized AI diagnostic for sepsis, providing rapid risk assessment and prediction of adverse outcomes. It analyzes 22 parameters from EHRs to generate a risk score and four risk categories, aiding clinicians in faster treatment decisions and improved patient outcomes.

What the Web Says

Prenosis is a health tech company that has developed the Sepsis ImmunoScore, an AI-powered diagnostic and predictive tool for early sepsis detection. The Sepsis ImmunoScore received FDA De Novo marketing authorization in 2024, making it the first AI diagnostic test for sepsis. The tool integrates with hospital EHRs, analyzes 22 health metrics, and provides a sepsis risk score to help clinicians diagnose infections and predict which patients are likely to progress to severe cases. While there is significant positive sentiment around the product's potential to save lives and improve patient outcomes, there is no readily available information on company/employer reviews for Prenosis specifically on the requested platforms.

Overall: Mixed

Strengths

  • First FDA-authorized AI diagnostic tool for sepsis.
  • High accuracy for sepsis diagnosis and prediction of adverse patient outcomes.
  • Integrates with hospital EHRs for real-time information and timely interventions.
  • Analyzes a comprehensive set of 22 biological and clinical parameters.
  • Potential to reduce antibiotic overprescription and improve compliance with payer protocols.
  • Transparent algorithmic methodology to build trust with clinicians.

Limitations

  • No readily available company/employer reviews on G2, Glassdoor, Capterra, or Reddit.
  • No specific product cons identified in the search results.

Last updated: 2026-07-20

Videos

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Press & Coverage

PR Newswire
Prenosis Announces FDA De Novo Marketing Authorization of the Sepsis ImmunoScoreu2122, Its Revolutionary Artificial Intelligence Diagnostic and Predictive Tool for Early Sepsis Detection
Prenosis announced that the FDA granted marketing authorization for its Sepsis ImmunoScore, the first-ever AI diagnostic tool for sepsis, which uses AI/machine learning to guide rapid diagnosis and prediction of sepsis.
2024-04
HLTH
Prenosis Secures $40M to Advance Precision Medicine Infrastructure for Critical Care
Prenosis secured $40 million in new funding, comprising a $20 million Series A financing round and a $20 million federal contract from BARDA, to advance its precision medicine platform and commercialize the Sepsis ImmunoScore.
2026-01
Akin Gump
FDA Authorizes First AI-Enabled Test to Predict Sepsis
The FDA granted De Novo authorization to Prenosis Inc.'s Sepsis ImmunoScore device, marking the first AI-enabled diagnostic tool for sepsis to receive such clearance.
2024-04
RT - Respiratory Therapy
Roche to Distribute Sepsis ImmunoScore from Prenosis
Roche will commercially distribute Prenosis Inc.'s Sepsis ImmunoScore, the first FDA De Novo authorized AI diagnostic tool for sepsis, making it available on Roche's navify Algorithm Suite.
2024-04
PR Newswire
Sepsis ImmunoScoreu2122 Named a TIME Best Invention of 2024
Prenosis Inc.'s Sepsis ImmunoScore was named one of TIME's Best Inventions of 2024, recognized for its groundbreaking role as the first FDA-authorized AI diagnostic and predictive tool for sepsis.
2024-10
Prenosis
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 concluded that the Sepsis ImmunoScore, the first FDA-authorized AI diagnostic for sepsis, demonstrates high accuracy for sepsis diagnosis and prediction of adverse patient outcomes.
2024-12
Pharma Tech
BioAegis and Prenosis partner for inflammatory disease therapies
BioAegis Therapeutics and Prenosis have partnered to advance AI-driven precision medicine for inflammatory diseases, with Prenosis utilizing its platform to analyze biospecimens and data from BioAegis' Phase II BTI-203 trial.
2026-04
TipRanks
Prenosis Highlights AI-Driven Precision Medicine Approach in Sepsis Care Webinar
Prenosis highlighted an upcoming webinar with the Ohio Hospital Association focusing on precision medicine in sepsis care, where a Prenosis representative will discuss the role of AI-derived biomarkers and technology platforms in improving sepsis identification.
2026-07

Frequently Asked Questions

Prenosis primarily offers the Sepsis ImmunoScoreu00ae, an FDA-authorized AI diagnostic tool designed to assess a patient's risk for sepsis and predict adverse outcomes within 24 hours. This tool leverages 22 diverse parameters, including biomarkers and clinical data, to provide a comprehensive risk score. It is built on their Immunixu2122 precision medicine platform, which is also being developed to create diagnostics and therapeutics for other acute care conditions like pneumonia and acute heart failure.
Prenosis's Sepsis ImmunoScoreu00ae is the first AI diagnostic tool for sepsis to receive FDA marketing authorization through the De Novo pathway, demonstrating its regulatory compliance and novel nature. The company emphasizes a transparent AI approach and integrates with Electronic Medical Records (EMRs), with team members possessing expertise in HIPAA de-identification for compliant data use.
Prenosis utilizes an enterprise subscription pricing model for its Sepsis ImmunoScoreu00ae, with costs varying based on the specific size and needs of each client healthcare system. Specific pricing details are not publicly disclosed, as is common for enterprise-level healthcare technology solutions.
Prenosis's Sepsis ImmunoScoreu00ae is designed for direct integration into existing hospital Electronic Medical Record (EMR) systems, ensuring seamless clinical workflow adoption. They offer an intuitive display that transparently shows how each patient's parameters contribute to their sepsis score, fostering clinician trust and facilitating a true clinician-AI partnership. Their team includes dedicated integration and commercialization executives to assist with deployment and ongoing engagement.
Yes, Prenosis has a significant commercial distribution collaboration with Roche Diagnostics, making the Sepsis ImmunoScoreu00ae available on Roche's navifyu00ae Algorithm Suite platform. They have also partnered with at least ten U.S. hospital systems to build their extensive biobank and clinical dataset, which underpins their AI development. Additionally, Prenosis secured a $20 million contract from the Biomedical Advanced Research and Development Authority (BARDA).
Founded in 2014, Prenosis recently completed a $20 million Series A financing round led by PACE Healthcare Capital, with participation from other notable investors including UC Investments and the Labcorp Venture Fund. This private funding, combined with a $20 million federal contract from BARDA, brings their total new funding to $40 million, demonstrating strong financial backing and a commitment to expanding their precision medicine initiatives.

Investors

Who's funded Prenosis.

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