US-based healthcare system Mercy has announced that its data supported the US Food and Drug Administration (FDA) De Novo marketing authorisation of Prenosis’ Sepsis Immunoscore tool.

Sepsis ImmunoScore is an artificial intelligence (AI)/machine learning software as a medical device (AI SaMD).

It is designed for rapid diagnosis and prediction of sepsis, a serious and challenging-to-diagnose infection response.

Mercy comprises a highly integrated healthcare system spanning multiple states, including over 50 acute care hospitals and speciality facilities.

Additionally, Mercy operates convenient and urgent care centres, imaging facilities, and pharmacies within its network.

The firm’s participation as one of 10 study sites across the US supported testing the tool, leading to its authorisation.

Since 2019, Mercy Research has contributed 30,000 blood samples to Prenosis for this study.

Prenosis utilised these samples to assess the effectiveness of the Sepsis ImmunoScore against sepsis. This tool integrates laboratory and clinical data to evaluate a patient’s infection response.

The Sepsis ImmunoScore assesses 22 diverse parameters to generate a risk score and category. This data is directly integrated into the hospital’s electronic records, ensuring accessibility for clinicians.

Additionally, the tool provides insights into how each factor influences the overall score, supporting the patient care team to trust and understand the results. 

Mercy virtual inpatient services vice president Ashok Palagiri said: “We know how dangerous sepsis can be, and having tools to detect it quickly is crucial.

“This clinical trial and research is essential in spotting sepsis early. We are grateful to have contributed to this research and we’re hopeful this tool will save lives.”

Prenosis, an AI company allowing precision medicine in acute care, secured FDA marketing authorisation for Sepsis ImmunoScore in April this year under the De Novo pathway.

The Sepsis ImmunoScore is based on Prenosis’ Immunix precision medicine platform, designed to facilitate precision medicine within acute care settings.

Immunix supports creating and validating new precision medicine tools, enabling their real-time deployment to enhance patient care and outcomes.