PRENOSIS ANNOUNCES COMMERCIAL DISTRIBUTION COLLABORATION WITH ROCHE FOR SEPSIS IMMUNOSCORE™, THE FIRST FDA DE NOVO AUTHORIZED ARTIFICIAL INTELLIGENCE TOOL FOR SEPSIS DETECTION

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Apr 10, 2024, 06:00 ET

Prenosis will collaborate with Roche to bring the Sepsis ImmunoScore™ to hospitals across the United States on Roche's navify® Algorithm Suite platform

CHICAGO, April 10, 2024 /PRNewswire/ -- Today, Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, announced a commercial distribution collaboration with Roche for its Sepsis ImmunoScore™, an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis of sepsis and prediction of adverse outcomes. The Sepsis ImmunoScore™, the first-ever FDA De Novo authorized AI diagnostic tool for sepsis, will be available on Roche's navify® Algorithm Suite. The Suite provides the advantage of offering Roche and third party evidence-based, certified medical algorithms to customers in one solution platform (spanning disease areas). Offering clinicians and lab managers an integrated solution, navify® Algorithm Suite aims to transform every stage of care and for confident decision making.

Sepsis accounts for one in every three hospital fatalities in the U.S. with an estimated 1.7 million American adults developing sepsis each year.¹ Numerous studies have demonstrated that earlier diagnosis and treatment of sepsis are crucial for increasing sepsis survival rates² and decreasing sepsis-related costs.³

"The timely and accurate diagnosis of sepsis has plagued emergency departments and hospitals for decades," said Kevin Klauer, DO, EJD, FACEP, FACOEP, CEO of the American Health Information Management Association, emergency room physician and hospital administrator. "Strategies and solutions have fallen short of expectations, placing patients at risk by overcalling sepsis in patients without sepsis, while overlooking many patients with sepsis. Providers need an innovative approach to this overwhelming issue. The Sepsis ImmunoScore™ – the first-ever AI sepsis diagnostic granted De Novo authorization by the FDA – provides a validated diagnostic and predictive solution, ushering in a true Clinician-AI partnership. With its proven accuracy, this solution detects the right patients early enough to save lives, while bending the cost curve by preserving resources for those requiring life-saving sepsis care."

Leveraging lab-based biomarkers (for example Procalcitonin), clinical data and AI, the Sepsis ImmunoScore™ holistically evaluates a patient's chances of having or developing sepsis within 24 hours of patient assessment. Integrated into the Electronic Medical Record (EMR), it uses up to 22 diverse parameters to generate a risk score and assign the patient to one of four discrete risk stratification categories, based on the increasing risk of sepsis. "Including the Sepsis ImmunoScore in Roche's navify® Algorithm Suite is a great step forward for the Sepsis ImmunoScore™," said Bobby Reddy, Jr., Prenosis Co-Founder and CEO. "The navify® Algorithm Suite seeks to offer a collection of algorithms that have undergone clinical validation by an expert medical and cross-functional team at Roche. With the extensive market reach of Roche Diagnostics and ethical standards for AI-driven solutions, more hospitals and healthcare providers can take advantage of ImmunoScore™, and its clinical utility in the fight against sepsis, in a responsible way."

To develop the Sepsis ImmunoScore™, Prenosis spent a decade working with hospital systems to build its proprietary biobank, dataset, and its Immunix™ precision medicine platform. To date, Prenosis has gathered more than 100,000 blood samples from over 25,000 patients at ten health systems across the United States. Prenosis enhances typical hospital clinical datasets by generating additional key biological data from these samples in its Biological Safety Level 2 lab in Chicago. Its dataset, the largest in the world for fast-moving immune response in acute care settings, combines biomarker and clinical data for patients suspected of infection. This proprietary dataset enables the rapid development of a pipeline of AI diagnostics and precision therapeutics for acute care, including the Sepsis Immunoscore™.

Prenosis

At Prenosis we believe healthcare should be tailored to individual biology. With our data-driven approach to fast-moving biology in acute care environments, we're ushering in a new era of precision medicine in acute care. Our Immunix™ precision medicine platform generates proprietary biological insights to rapidly develop precision medicine products and enables the real-time delivery of optimal precision therapy in acute care. The platform is based on the world's largest and fastest growing biomarker-clinical dataset for rapid immune response. Using Immunix™, we created and validated the Sepsis ImmunoScore™, the first FDA-authorized AI diagnostic for sepsis.

At Prenosis we enable the healthcare ecosystem to see people differently. More information at www.prenosis.com

References
1 https://www.cdc.gov/sepsis/what-is-sepsis.html
2 Jones SL et al. "Reductions in Sepsis Mortality and Costs After Design and Implementation of a Nurse-based Early Recognition and Response Program." Jt Comm J Qual Patient Saf, vol. 41, no. 11. 2015, pp.483–91
3 Judd WR, Stephens DM, Kennedy DA. "Clinical and Economic Impact of a Quality Improvement Initiative to Enhance Early Recognition and Treatment of Sepsis." Ann Pharmacol, vol. 48, no. 10. 2014, pp. 1269–75

SOURCE Prenosis