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Prenosis Gains FDA De Novo Authorization for Sepsis Diagnostic Software

NEW YORK – Diagnostics startup Prenosis said on Wednesday that the firm has secured US Food and Drug Administration de novo marketing authorization for its software to aid the diagnosis of and predict the risk of sepsis.

The Chicago-based firm said that its Sepsis ImmunoScore software is used to analyze a combination of biomarkers and patient clinical data as it leverages 22 parameters to generate a risk score of a patient's likelihood to develop sepsis. The artificial intelligence and machine learning-based tool integrates into hospital electronic medical records, and it displays for clinicians how each patient's sepsis risk score was calculated.

Prenosis Cofounder and CEO Bobby Reddy said in a statement that ImmunoScore is the first FDA-authorized AI-based diagnostic for sepsis.

"FDA authorization offers yet another important piece of evidence of the potential of the Sepsis ImmunoScore to improve care," he said.

Company officials said a few years ago while they were preparing to submit the software for de novo clearance that the firm's sepsis testing system is used to analyze data collected from patients in the emergency room along with the results of tests for relevant biomarkers such as the proteins procalcitonin, interleukin-6, and C-reactive protein.