10-Minute Sepsis Risk Stratification Test Introduced at AACC 2022

Emergency department (ED) physicians tasked with diagnosing sepsis, a dysregulated immune (white blood cell) response to infection that can be life threatening, often face a scarcity of information that could lead to over- or under-treatment. Now, a new instrument and sepsis risk stratification test launched at the 2022 AACC Annual Scientific Meeting and Clinical Lab Expo could help address this challenge.

At AACC 2022, Cytovale (San Francisco, CA, USA) revealed its 510(k) pending Cytovale system and 10-minute IntelliSep sepsis risk stratification test, and also shared new data featuring the test. The Cytovale system directly analyzes white blood cells using rapid techniques that look at cell structure, which may make it faster and less expensive than other approaches. The IntelliSep test aims to simply and clearly determine the risk of a patient having sepsis using a biomechanical evaluation of white blood cells from a standard blood draw at presentation, generating results in under 10 minutes.

Microfluidic cell-handling techniques combined with the technological advances of high-speed imaging and machine learning allow the Cytovale system to analyze the biophysical properties of tens of thousands of leukocytes, yielding a score called the IntelliSep Index (ISI). The ISI results are stratified into three interpretation bands corresponding to regions of low (Green Band), intermediate (Yellow Band), and high (Red Band) risk for sepsis. Cytovale recently fulfilled the target enrollment of the CV-SQuISH-ED study involving the IntelliSep test at four clinical study sites across the country and has included the data from that study in a 510(k) submission to FDA. Data presented at AACC 2022 compared the ISI to ED diagnosis and indicated that the ISI could provide valuable information to help EDs rapidly triage patients more effectively.

“We’re excited to share the IntelliSep test with the global laboratory science community at AACC 2022. While nearly a dozen instruments have already been operated in clinical labs at facilities across the U.S., the next logical step now that the clinical validation study has been completed and our 510(k) filing has been submitted, is to engage more broadly with those who may benefit from our potentially critical and time-saving tool that could change the way emergency departments recognize and treat sepsis,” said Cytovale co-founder and CEO Ajay Shah. “We encourage all in attendance at the meeting to come learn about the investigational IntelliSep test and how it may address the need to more quickly and accurately assess and triage potential sepsis patients.”

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