Cytovale Reveals 10-Minute, 510(k) Pending Cytovale System and IntelliSep Test for Sepsis
25 July 2022 - - US-based medical diagnostics company Cytovale, which is focused on providing tools to improve early detection of fast-moving and immune-mediated diseases, will reveal its 510(k) pending Cytovale system and 10-minute IntelliSep sepsis risk stratification test at the American Association for Clinical Chemistry annual meeting, where new data featuring the test will also be shared, the company said.

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 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, 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.

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 being presented at AACC 2022 compare the ISI to ED diagnosis and indicates that the ISI could provide valuable information to help EDs rapidly triage patients more effectively.

In the abstract, "A Rapid Cellular Host Response Test May Aid ED Decision Making for Sepsis Care" (Poster B-224), the ISI showed a significantly higher Positive Percent Agreement (PPA/Sensitivity) of 97.4% (86.2 99.9, 95% CI) and Negative Predictive Value of 99.4% (86.2 99.9, 95% CI) with a Green Band cutoff compared to ED Diagnosis at 50.0% PPA (33.4 66.6, 95% CI) and 92.7% NPV (78.6 98.3, 95% CI), respectively.

The data, which draw from studies prior to CV-SQuISH-ED, will be presented by Dr. Hollis O'Neal, critical care physician at Louisiana State University Health Sciences Center, Wednesday, July 27 from 1:30 to 2:30 pm CT in the poster hall.

Data from previously published studies have shown that Cytovale's IntelliSep test quickly and clearly distinguished mortality risk in a high-acuity population and accurately identified patients with infections severe enough to cause morbidity and mortality.

These data demonstrate the 10-minute test's potential to aid physicians in rapidly identifying patients at increased risk of having or developing sepsis.

Cytovale is a medical diagnostics company focused on providing rapid and insightful tools to improve early detection of fast-moving and immune-mediated diseases.

Cytovale's investigational IntelliSep test is pioneering a new way of quickly and accurately analyzing white blood cells to stratify a patient's risk of sepsis. The test is designed to quantify the state of immune activation by measuring the biophysical properties of leukocytes from a routine blood sample in under 10 minutes.