Roche to Distribute Sepsis ImmunoScore from Prenosis

Sepsis ImmunoScore, the first FDA-authorized artificial intelligence diagnostic for sepsis, will be available on Roche’s navify Algorithm Suite.

RT’s Three Key Takeaways

1. Prenosis Inc, collaborating with Roche, announced the commercial distribution of its FDA De Novo authorized AI diagnostic tool for sepsis, the Sepsis ImmunoScore, integrated into Roche’s navify Algorithm Suite.
2. The Sepsis ImmunoScore employs AI, clinical data, and lab-based biomarkers to evaluate a patient’s risk of developing sepsis within 24 hours, aiming to facilitate early diagnosis and treatment, crucial for improving survival rates and reducing associated costs.
3. With a decade of research and a proprietary dataset of over 100,000 blood samples, Prenosis developed the Sepsis ImmunoScore to provide clinicians with a validated diagnostic and predictive solution to address the challenges of sepsis diagnosis in acute care settings.

Roche will commercially distribute Prenosis Inc’s Sepsis ImmunoScore, the first-ever FDA De Novo authorized AI diagnostic tool for sepsis, according to a press release.

Sepsis ImmunoScore is an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis of sepsis and prediction of adverse outcomes. The product will be available on Roche’s navify Algorithm Suite.

Sepsis accounts for one in every three hospital fatalities in the US 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

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.

Stakeholder Reaction

“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. “…With its proven accuracy, [Sepsis ImmunoScore] detects the right patients early enough to save lives, while bending the cost curve by preserving resources for those requiring life-saving sepsis care.”

“Including the Sepsis ImmunoScore in Roche’s navify Algorithm Suite is a great step forward for the Sepsis ImmunoScore^TM,” 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.”

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