SAN FRANCISCO– Cytovale, a medical diagnostics company focused on providing rapid and insightful tools to improve early detection of fast-moving and immune-mediated diseases, today announced a new study on its investigational IntelliSep test has been published in the peer-reviewed journal PLOS ONE. The study, “Assessment of a cellular host response test to risk-stratify suspected COVID-19 patients in the Emergency Department setting,” demonstrated that the IntelliSep test has the potential to rapidly risk-stratify patients independent of pathogen, an important finding as risk stratification may improve resource allocation in hospitals. Data from the study shows that Cytovale’s test has the potential to provide useful prognostic information for patients with suspected infection and possible immune dysregulation that can lead to life-threatening organ dysfunction.
This study, which enrolled 282 patients presenting to the Emergency Department (ED) with respiratory symptoms early in the COVID-19 pandemic, aimed to assess the IntelliSep Index (ISI) as a tool for risk stratification of patients with suspected infection presenting to the ED. The study reports the performance of this tool as a means to stratify this population for risk of morbidity and mortality resulting from infection with a novel respiratory virus, providing an important test of the value of this host-response technology in assessing severity of illness independent of pathogen type.
“The ongoing COVID-19 pandemic has revealed how stretched our healthcare resources are and illustrated a need for tools and technologies to help ensure appropriate resources are available to support emergent cases,” said Dr. Hollis R. O’Neal Jr., a critical care physician at the Louisiana State University Health Sciences Center and a principal investigator of the study. “In these situations, a pathogen-agnostic assessment of the host response, such as Cytovale’s IntelliSep test, may assist clinicians in the risk stratification of persons under investigation for infection by providing a patient-centered, objective assessment of the state of immune activity.”
The Cytovale system directly analyzes white blood cells using rapid techniques that look at cell structure, making it a faster and less expensive diagnostic compared to gene expression diagnostic systems. Cytovale’s IntelliSep test uses a biomechanical evaluation of white blood cells from a standard blood draw, generating results in under ten 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 thousands of leukocytes in a few seconds, yielding the ISI score. The ISI is a pathogen-agnostic, quantitative measure of immune activation. In patients with suspected infection, elevated ISI indicate a state of immune dysregulation and portend an immediate risk of adverse outcomes, while lower scores portend a less-severe course. The ISI results are stratified into three interpretation bands corresponding to regions of low (Green Band), intermediate (Yellow Band), and high probability (Red Band) of severe outcomes.
In this study, 182 (64.5%) patients received a green score, while 54 (18.1%) received a yellow score, and 46 (15.6%) a red score. Patients who received a red score had a 3-day mortality rate of 10.9%, approximately ten-fold higher than the 1.1% 3-day mortality rate experienced by patients receiving a green score. In addition, a lower percentage of green band patients required admission (96 [52.7%]) relative to those receiving yellow (44 [81.5%]) and red scores (43 [93.5%]).
“Patients frequently present to the ED with undifferentiated illnesses, forcing clinicians to make rapid, impactful decisions with limited data, often well before a definitive diagnosis is established,” said Cytovale Co-founder and CEO Ajay Shah. “Data from this study published in PLOS ONE demonstrate the potential of the IntelliSep test to assist clinicians in the risk stratification and early direction of care for patients before the results of longer-lead time diagnostic tests are available. This may enable ED providers to triage their own resources and most effectively serve all of their patients.”
Data from this study builds on previously published studies that have shown that Cytovale’s IntelliSep test quickly and clearly distinguished sepsis risk in a high-acuity population and helped to identify patients with infections severe enough to cause morbidity and mortality1. These data demonstrate the ten-minute test’s potential to aid physicians in rapidly identifying patients at increased risk of having or developing sepsis2, a dysregulated immune (white blood cell) response to infection, which is highly lethal and difficult to quickly and accurately diagnose.
