Cytovale will reveal its 510(k) pending Cytovale system and 10-minute IntelliSep sepsis risk stratification test at the American Association for Clinical Chemistry (AACC) annual meeting, where new data featuring the test will also be shared.
The instrument can be seen in the Cytovale booth, no. 5045, in the exhibit hall during Clinical Lab Expo hours. The IntelliSep test was recently named an AACC Disruptive Technology Award Semifinalist and is also being featured in the Disruptive Tech area of the exhibit hall during the meeting.
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. To help address this challenge, the Cytovale system directly analyzes white blood cells using rapid techniques that look at cell structure. 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.