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 focused on redefining the standard of care for critical conditions through integrated diagnostics and therapeutics. The company’s core mission is to tailor healthcare to each patient’s unique biology by leveraging deep data and artificial intelligence (AI). Their flagship product, Sepsis ImmunoScore®, is the first FDA-authorized AI diagnostic tool for sepsis, designed to assist providers in identifying patients at risk for sepsis or its progression within 24 hours. This tool integrates up to 22 parameters, including lab biomarkers, vital signs, and demographics, to provide an individualized risk assessment and stratify patients into four discrete risk groups.

For physicians, Prenosis’s technology aims to augment clinical decision-making by providing real-time, transparent insights into a patient’s biological status. The Sepsis ImmunoScore® integrates directly into hospital Electronic Medical Record (EMR) systems, presenting an intuitive display that reveals how individual patient parameters contribute to their risk score, fostering trust and a clinician-AI partnership. Beyond sepsis, Prenosis is expanding its precision medicine platform, Immunix™, to address other critical care conditions such as pneumonia, acute heart failure (AHF), acute respiratory distress syndrome (ARDS), and acute kidney injury (AKI). The company’s approach emphasizes moving beyond one-size-fits-all protocols to deliver personalized care, ultimately aiming to improve patient outcomes and reduce hospital costs.

What Physicians Need to Know

Specialization
Prenosis specializes in developing AI-powered diagnostic and predictive tools for acute care, with a primary focus on sepsis.
Key Product
Their flagship product, the Sepsis ImmunoScore, is the first FDA-authorized AI diagnostic tool for sepsis.
Core Technology
Prenosis leverages its Immunix precision medicine platform, which is built upon the world's largest biobank linked to clinical data for infection in acute care.
Data-Driven Approach
The Sepsis ImmunoScore was developed using a proprietary dataset of over 100,000 blood samples from more than 25,000 patients, enabling a deep understanding of individual patient biology and immune responses.
Regulatory Achievement
The Sepsis ImmunoScore received FDA De Novo marketing authorization, signifying its novelty and potential to improve care for a condition that previously lacked an authorized AI diagnostic.
Physician Tip

For physicians, Prenosis' Sepsis ImmunoScore offers a powerful tool for earlier and more accurate sepsis diagnosis and risk assessment. It analyzes up to 22 diverse parameters from a patient's Electronic Health Record (EHR), including biomarkers and clinical data, to generate a risk score and assign patients to one of four discrete risk categories. This tool not only aids in diagnosing sepsis but also predicts critical outcomes such as in-hospital mortality, length of stay, ICU admission, mechanical ventilation, and vasopressor use within 24 hours. The Sepsis ImmunoScore is designed for seamless integration into existing hospital EHR/EMR systems and provides a transparent display explaining how each parameter contributed to the final score, fostering trust and a true clinician-AI partnership. This allows for more personalized treatment decisions, potentially leading to improved patient outcomes, reduced hospital costs, and better compliance with quality metrics like the SEP-1 bundle.

The Sepsis ImmunoScore is designed for direct integration into hospital Electronic Health Records (EHRs) and Electronic Medical Records (EMRs). It has the potential to utilize FHIR backend platforms for data integration. Prenosis has also partnered with Roche for the commercial distribution of the Sepsis ImmunoScore, making it available on Roche's navify Algorithm Suite.

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 company that has developed the Sepsis ImmunoScore, an AI-powered diagnostic tool for early sepsis detection and prediction of patient outcomes. The Sepsis ImmunoScore was authorized by the FDA in 2024, making it the first AI diagnostic test for sepsis. The tool analyzes 22 health metrics to provide a sepsis risk score and predict the likelihood of severe cases within 24 hours. While the product has received positive attention for its innovative approach to sepsis diagnosis, there is limited accessible review coverage for Prenosis on traditional software review platforms like G2, Capterra, and TrustRadius.

Overall: Mixed

Strengths

  • FDA-authorized AI diagnostic tool for sepsis, the first of its kind.
  • Utilizes AI to analyze 22 health metrics for early sepsis detection and outcome prediction.
  • Aims to reduce antibiotic overprescription and improve identification of SEP-1 bundle non-compliance cases.
  • Recognized by TIME magazine as one of the best inventions of 2024 for saving crucial time in medical care.
  • Designed to augment clinician decision-making rather than replace it.
  • Potential to transform sepsis management by providing trustworthy predictive information for a proactive approach to care.

Limitations

  • Limited accessible review coverage on traditional software review platforms (G2, Capterra, TrustRadius).
  • Potential limitations if required lab biomarkers are not available or cannot be operationalized with suitable turnaround time.
  • May face challenges if organizations are tightly constrained to EHR-native workflows and cannot integrate a separate Software as a Medical Device (SaMD).
  • Publicly available materials do not clearly document SOC 2/ISO certifications, which may be a barrier for some procurement processes.
  • Some employee reviews for companies with similar names (e.g., Prenuvo, Prominis, ProNexis) mention issues with work-life balance, management, and pay, though these are not confirmed to be for Prenosis.

Based on reviews from: G2.com, Substack.com, cmrubinworld.com, Time.com, Beckershospitalreview.com, Prenosis.com, Healthcarenowradio.com, Simplyhired.com, Proximacro.com, Indeed.com, Softwareadvice.com, Healthcareittoday.com, Airframe.ai, Bizjournals.com, Lensa.com, Capterra.com, Reddit.com, Cablesandkits.com, Jobtoday.com

Last updated: 2026-10-29

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Press & Coverage

PR Newswire
Prenosis Announces FDA De Novo Marketing Authorization of the Sepsis ImmunoScore™, Its Revolutionary Artificial Intelligence Diagnostic and Predictive Tool for Early Sepsis Detection
Prenosis received FDA De Novo marketing authorization for its Sepsis ImmunoScore™, the first AI diagnostic tool for sepsis, designed to guide rapid diagnosis and prediction of sepsis. This tool leverages AI and 22 diverse parameters to assess a patient's risk of sepsis or progression within 24 hours.
2024-04
Prenosis
Prenosis Announces Commercial Distribution Collaboration with Roche for Sepsis ImmunoScore™
Prenosis announced a commercial distribution collaboration with Roche to make its Sepsis ImmunoScore™ available on Roche's navify® Algorithm Suite platform. This partnership aims to bring the FDA-authorized AI diagnostic tool for sepsis to hospitals across the United States.
2024-04
HLTH
Prenosis Secures $40M to Advance Precision Medicine Infrastructure for Critical Care
Prenosis announced $40 million in new funding, comprising a $20 million Series A financing round and a $20 million contract from BARDA. This funding will support the commercial rollout of Sepsis ImmunoScore® and advance the development of biology-driven solutions for critical care.
2026-01
PR Newswire
Prenosis and Carle Health Mark Sepsis ImmunoScore® Clinical Deployment and First Patients Enrolled in OBSERVE-ARDS Clinical Study
Prenosis announced the clinical deployment of Sepsis ImmunoScore® at Carle Health and the enrollment of the first patients in its OBSERVE-ARDS clinical study. This marks a significant step in integrating the AI diagnostic tool into clinical workflows and expanding research into acute respiratory distress syndrome.
2026-10
Fierce Healthcare
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 diagnostic tool, into clinical use. This deployment brings the FDA-authorized software to the bedside to aid in early sepsis detection and improve patient outcomes.
2026-07
MobiHealthNews
HIMSSCast: Prenosis CEO on using AI to detect sepsis
Dr. Bobby Reddy Jr., cofounder and CEO of Prenosis, discussed the company's Sepsis ImmunoScore and future plans for companion diagnostics in a HIMSSCast interview. He highlighted how AI helps clinicians identify sepsis earlier and the company's move towards precise novel therapeutics.
2026-09
Prenosis
Sepsis ImmunoScore™ Named a TIME Best Invention of 2024
Prenosis' Sepsis ImmunoScore™ was recognized as one of TIME's Best Inventions of 2024. This highlights the impact of the FDA-authorized AI diagnostic test in revolutionizing sepsis diagnosis and prediction.
2024-10
NIH (Infectious Diseases Society of America)
Evaluation of an FDA-Authorized AI Biomarker of Sepsis to Predict Mortality over Time in Patients Suspected of Infection
A prospective multicenter study evaluated the Sepsis ImmunoScore's ability to predict in-hospital mortality over time in patients suspected of infection. The study found that the Sepsis ImmunoScore significantly predicted patient survival and outperformed other common biomarkers.
2025-10

Frequently Asked Questions

Prenosis offers Sepsis ImmunoScore®, an FDA-authorized AI diagnostic tool designed to assess sepsis risk by combining biological markers with clinical data. This tool helps identify high-risk patients earlier in their hospital stay, supporting faster clinical decision-making during the early stages of sepsis progression. Prenosis is also developing an AI-enabled "companion diagnostic" to predict which patients with severe respiratory infections, including pneumonia and acute respiratory distress syndrome, are likely to benefit from corticosteroid therapy.
Prenosis's flagship product, Sepsis ImmunoScore®, is the first FDA-authorized AI diagnostic tool for sepsis, having received De Novo marketing authorization in 2024. The company has also completed an independent audit validating its security controls for sensitive healthcare data. They leverage FHIR for clinical data normalization and utilize robust security features, including HIPAA compliance, within their platform.
Prenosis utilizes an enterprise subscription pricing model, with costs varying based on the size and specific needs of each client. Their Sepsis ImmunoScore® product is exclusively distributed to hospitals and health systems through a partnership with Roche Diagnostics.
Prenosis designs its technology, such as Sepsis ImmunoScore®, for seamless integration directly into existing hospital Electronic Health Record (EHR) systems. They aim to provide transparency in their AI, with the Sepsis ImmunoScore® displaying how each of the 22 patient parameters contributed to the final score to build clinician trust. While specific details on ongoing support were not extensively detailed, their commitment to quality extends to deployment and support.
Prenosis has a significant commercial distribution partnership with Roche for its Sepsis ImmunoScore®, making the tool available through Roche's navify® Algorithm Suite. They have also secured a $20 million federal contract from the Biomedical Advanced Research and Development Authority (BARDA) for a randomized controlled trial on severe respiratory infections. Additionally, Labcorp Venture Fund is an investor in Prenosis.
Prenosis completed a $20 million Series A financing round and received a $20 million federal contract from BARDA in January 2026, bringing their total new funding to $40 million. Key investors include PACE Healthcare Capital, Labcorp Venture Fund, and Carle Health. This funding is intended to support the commercial rollout of Sepsis ImmunoScore® and advance their biology-driven solutions.

Investors

Who's funded Prenosis.

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