Cytovale, a California-based medical diagnostics company, has announced the expansion of its IntelliSep technology to the Froedtert & the Medical College of Wisconsin (MCW) health network.
IntelliSep, a US Food and Drug Administration (FDA)-cleared diagnostic test for early sepsis detection in emergency department (ED) settings, is now being introduced at the hospital in Milwaukee. This rollout represents the first implementation of IntelliSep in Wisconsin and the wider Midwest region.
The IntelliSep system is designed to identify sepsis quickly, providing a tool for emergency departments.
Froedtert & MCW health network associate chief medical laboratory officer Nathan Ledeboer said: “We are well aware of the difficulty in identifying potentially septic patients when they present to our ED. Any tool that we can deploy during ED triage to ensure that patients get the care that they need is invaluable.
“This is the first blood test our clinicians have ever had in their toolbox that provides valuable insight into a patient’s immune system to detect sepsis earlier and make more informed treatment decisions.”
Under the new initiative, patients arriving at Froedtert Hospital’s emergency department with symptoms of infection will be screened using IntelliSep.
Cytovale claims that preliminary data from other health systems indicate that IntelliSep has led to a 30% reduction in the relative risk of mortality.
The IntelliSep test provides an objective measure of a patient’s immune response by analysing blood samples to detect sepsis. Results are said to be available in approximately eight minutes, facilitating effective triage and enabling clinicians to direct patients to appropriate care pathways.
This expansion follows IntelliSep’s initial launch in hospitals across Louisiana and Mississippi through the Franciscan Missionaries of Our Lady Health System.
IntelliSep, which received FDA 510(k) clearance in December 2022, was commercially launched in August 2023.
The IntelliSep test categorises patients into three risk bands based on their likelihood of sepsis from a standard blood draw. It aims to enhance clinical outcomes, optimise resource utilisation, and assist hospitals in meeting Centers for Medicare & Medicaid Services (CMS) SEP-1 guidelines for timely sepsis treatment.
With a testing duration of approximately 10 minutes, IntelliSep is designed to offer ease of use, integration into existing care processes, and cost-effectiveness, aiding providers in recognising sepsis and making critical clinical decisions.
