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Overview

Sepsis poses a significant problem that needs attention in the hospital²

With over 50 million cases each year, sepsis causes 1 out of 5 deaths worldwide.³ Sepsis is a preventable, life-threatening organ dysfunction that occurs in response to an infection.⁴ When sepsis is not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death.⁵ In the US alone, >2.1 million cases of sepsis are hospitalized annually.⁶

Delayed detection

High mortality rates⁷
Severity of sepsis complications⁷
Increased length of stay⁷

High hospital costs

Increased length of stay⁷
Unexpected ICU escalations⁷
High readmission costs⁸

Burden on staff

High rate of diagnostic errors⁴
Low SEP-1 compliance⁹
High sepsis alert fatigue¹⁰

How sepsis contributes over $41 billion to US healthcare costs

Sepsis is estimated to cost the US healthcare system over $62 billion annually, but this figure is conservative and does not capture all related expenses. Key costs omitted include professional fees during inpatient treatment, skilled nursing facility expenses and outpatient care associated with sepsis.¹⁶ The true financial impact is likely much higher.¹⁶

$41Bin US hospital costs.

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Prenosis announces first FDA-authorized AI-based algorithm for sepsis detection

With the announcement of the Sepsis ImmunoScore™ collaboration with Roche, Prenosis CEO and co-founder Bobby Reddy, Jr. discusses how the algorithm will be brought to hospitals across the US and how artificial intelligence will change health care in treating sepsis on Fox Business' “The Claman Countdown."

Sepsis ImmunoScore™ solution overview

Targeting adult patients (18 and above), Sepsis ImmunoScore is an AI diagnostic tool that assists providers in identifying patients at risk for sepsis or developing sepsis within 24 hours. It combines up to 22 parameters, including lab biomarkers, vital signs and demographics to individualize risk. It assigns patients in one of four discrete risk groups based on the increasing probability of sepsis.¹

Patient centric

For every patient the algorithm uses lab biomarkers, vital signs and demographics, enabling a holistic and AI-assisted approach in sepsis management.

Supports diagnosis & prediction

Assists providers in assessing the risk of sepsis presence or progression within the next 24 hours by assigning patients to a specific risk group.

Insightful visualization

An EMR-integrated display presents sepsis risk parameters for each patient, offering insights into the model calculations and fostering trust.

A tablet displaying High risk category user interface.

It's about comprehensively understanding a patient's condition. First we need to have biological parameters in real-time and second, the component of AI adds that it is looking at patterns from thousands of previous patients.
Bobby Reddy, Jr. Ph.D. | CEO & Co-Founder, Prenosis

Image of Bobby Reddy, Jr., Ph.D. CEO & Co-Founder, Prenosis

Benefits

Sepsis ImmunoScore may help improve patient outcomes

Through the multidimensional inputs across different domains, the algorithm creates a comprehensive sepsis risk score for a given individual. It is highly predictive of sepsis and correlated to secondary outcomes of in-hospital mortality, hospital length of stay, ICU admission and vasopressor usage within 24 hours.^12,13

Highly predictive of sepsis

As the Sepsis ImmunoScore risk category increases, the likelihood of having or developing sepsis rises significantly.¹²

Intuitive display

Visualization and explanation of results can build trust for a clinician-AI partnership.

Assists clinicians in decision making

May equip clinicians with faster insights and potentially allow them to better plan and coordinate resources based on the predicted presence or likelihood of progression to sepsis.¹³

Integration

Integration via navify Algorithm Suite

Experience a single integrated platform designed for healthcare providers and laboratories that simplifies IT complexity while reducing vulnerabilities. With integrated Roche and partner medical algorithms, we provide a comprehensive solution that streamlines processes and enhances collaboration.

A flow chart illustrating the integration via navify Algorithm Hub, connecting patients, healthcare providers and laboratory systems.

A laptop screen displaying centralized customer an user interface of online support for algorithms.

Single point of contact for customer support

Roche offers centralized customer support for all algorithms in our portfolio to ensure consistency and reliability. We manage issues that arise for all hosted algorithms, streamlining the process and eliminating the need for customers to engage with individual providers.

Security and data privacy

Security and data privacy are central to Roche's operations founded on a "Secure by Design" philosophy and ISO 27001 certification. Our dedicated technical team performs ongoing risk assessments, penetration tests and network monitoring to minimize IT complexity and vulnerabilities, prioritizing data confidentiality to protect patient information across all partners.

FAQs

Frequently asked questions

Contact our experts

What is the intended use of Sepsis ImmunoScore?

Sepsis ImmunoScore uses up to 22 predetermined inputs from the patient's electronic health record to generate a risk score and to assign the patient to one of four discrete risk stratification categories, based on the increasing risk of sepsis.¹

Sepsis ImmunoScore is intended to be used in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment for the presence of or progression to sepsis within 24 hours of patient assessment.¹

It is intended to be used for patients admitted to the Emergency Department or hospital for whom sepsis is suspected and a blood culture was ordered as part of the evaluation for sepsis. It should not be used as the sole basis to determine the presence of sepsis or the risk of developing sepsis within 24 hours.¹

How does Sepsis ImmunoScore work?

Patient admitted to ED / ICU with suspected sepsis or infection. As a medical emergency, the early diagnosis of sepsis is vital for every hour that treatment is delayed, the risk of death increases by 7.6%.¹⁴
Clinician orders blood test and standard sepsis bundle test.
Clinician orders confirmatory test: Sepsis Immunoscore™, predictive of sepsis and adverse clinical outcomes and used in sepsis diagnosis.
Clinician continues to observe and collect new data and vital signs for algorithm input.
Using the input parameters, the algorithm calculates the patient's sepsis risk (of having or developing sepsis within 24 hours) of the Sepsis ImmunoScore order.
The risk score is divided into four risk stratification categories, which may better equip healthcare professionals in clinical management and may help better planning and coordination of resources, based on the predicted presence or likelihood of progression to sepsis.

How is Sepsis ImmunoScore different from other existing sepsis technology such as early warning systems?

Sepsis ImmunoScore™ is an FDA-authorized holistic and AI-assisted tool, with both diagnostic and predictive power. By using advanced algorithms and combining single biomarkers with vital signs and demographics to analyze patient-specific data, Sepsis ImmunoScore aids healthcare providers in the prediction and/or diagnosis of, rather than solely monitoring for sepsis. Integrating Sepsis ImmunoScore with an early warning system could improve the accurate identification of true sepsis patients and could reduce the clinician burden of false alerts. Beyond early warning, Sepsis ImmunoScore is a paradigm change for patients to receive the appropriate level of sepsis care.¹

How is Sepsis ImmunoScore made available in the hospital? Are there any technical requirements?

Where is the suite/product deployed?

Prenosis

Prenosis, Inc. is a biology-based technology company redefining the standard of care for critical conditions. We believe healthcare should not follow a one-size-fits-all model. Instead, our mission is to tailor healthcare to each patient's biology through the creation and delivery of integrated diagnostics and therapeutics. We use deep data and AI to build tools that augment clinical diagnosis of critical conditions based on each patient's unique biological profile. Unlike other AI-driven diagnostics, we go further by developing therapies that help providers deliver personalized care. Our Immunix™ platform powers the development of a variety of AI-based diagnostics, including Sepsis ImmunoScore^TM. At Prenosis, we see people differently. For more information, visit us at prenosis.com or find us on LinkedIn.

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References and notes

U.S. Food & Drug Administration. Device Classification Under Section 513(f)(2) (De Novo) [Internet; cited 2024 Oct]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230036.
Arefian H, et al. Hospital-related cost of sepsis: A systematic review. J Infect. 2017 Feb;74(2):107-117. DOI:10.1016/j.jinf.2016.11.006.
Rudd KE et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan;395(10219):200-211. DOI:10.1016/S0140-6736(19)32989-7.
Singer M, et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA: 2016;315(8):801-810. DOI:10.1001/jama.2016.0287.
Martin GS. Sepsis, severe sepsis and septic shock: changes in incidence, pathogens and outcomes. Expert Rev Anti Infect Ther. 2012 Jun;10(6):701-6. DOI:10.1586/eri.12.50.
Owens PL, et al. Overview of outcomes for inpatient stays involving sepsis, 2016–2021. HCUP Statistical Brief #306 [Internet; published 2024 Apr; cited 2024 Oct]. Available from: https://hcup-us.ahrq.gov/reports/statbriefs/sb306-overview-sepsis-2016-2021.pdf.
Paoli CJ, et al. Epidemiology and costs of sepsis in the United States - an analysis based on timing of diagnosis and severity level. Crit Care Med. 2018 Dec;46(12):1889-1897. DOI:10.1097/CCM.0000000000003342.
Gadre SK, et al. Epidemiology and predictors of 30-day readmission in patients with sepsis. Chest. 2019 Mar;155(3):483-490. DOI:10.1016/j.chest.2018.12.008.
Barbash IJ, et al. National performance on the Medicare SEP-1 Sepsis Quality Measure. Crit Care Med. 2019 Aug;47(8):1026-1032. DOI:10.1097/CCM.0000000000003613.
Hwang MI, et al. Sepsis alerts in emergency departments: a systematic review of accuracy and quality measure impact. West J Emerg Med. 2020 Aug;21(5):1201-1210. DOI:10.5811/westjem.2020.5.46010.
Newman-Toker DE, et al. Diagnostic errors in the Emergency Department: A systematic review [Internet]. Rockville, MD: Agency for Healthcare Research and Quality (US); 2022 Dec. DOI:10.23970/AHRQEPCCER258.
DOC-69-Ext-001 Sepsis ImmunoScore™ Clinical Performance Validation Report Extension 1 (used for FDA submission purposes).
Bhargava A, et al. Validation of a machine learning diagnostic tool for the prediction of sepsis and critical illness. medRxiv [Pre-print] 2024 May. DOI:10.1101/2024.05.06.24306954.
Kumar A, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589–1596. DOI:10.1097/01.CCM.0000217961.75225.E9.
Sepsis Alliance. IT’s About TIME [Internet; cited 2024 Jan 1]. Available from: https://www.sepsis.org/about/its-about-time/.
Buchman TG, et al. Sepsis among medicare beneficiaries: 2. The trajectories of sepsis, 2012-2018. Crit Care Med. 2020 Mar;48(3):289-301. DOI:10.1097/CCM.0000000000004226.

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