Cytovale System IntelliSep test
The Cytovale System on which the IntelliSep diagnostic is run. [Image from Cytovale’s website]

Cytovale announced today that it received FDA 510(k) clearance for its IntelliSep test for the early detection of sepsis.

San Francisco-based Cytovale designed IntelliSep to provide test results in under 10 minutes. The emergency department-focused tool helps clinicians recognize sepsis and make time-sensitive critical decisions. It provides actionable answers directly from a standard blood draw.

The diagnostic categorizes patients into three bands according to their probability of sepsis. Band 1 indicates a low probability of sepsis and the probability increases through Band 3. These results can help optimize clinical outcomes and improve hospital resource utilization, Cytovale said.

Cytovale completed its CV-SQuISH-ED study of the diagnostic in early 2022 and plans for publication soon. Data from previous studies demonstrate the test’s potential in detecting sepsis, the company said.

IntelliSep runs on the Cytovale System, assessing the body’s immune response to an infection using immune cell morphology.

“This clearance is a pivotal step forward in Cytovale’s commitment to early detection technologies to improve health,” said Cytovale co-founder and CEO Ajay Shah. “IntelliSep has the potential to transform clinical approaches to sepsis triage and diagnosis and save countless lives.”

Cytovale plans to make IntelliSep available in the U.S. in the coming weeks.

“IntelliSep is truly a game changer for sepsis because it provides a unique indicator that gets to the heart of the current sepsis definition, immune dysregulation,” said Dr. Hollis O’Neal, critical care physician at LSU Health Sciences Center and national principal investigator on the CV-SQuISH-ED study. “The test provides hospital staff with the information needed to identify and treat septic patients efficiently and reduce the financial and health burdens of overtreatment for hospitals and patients.”