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New Study Supports Cytovale IntelliSep Test as Promising Tool to Aid in the Rapid Diagnosis of Sepsis in the Emergency Department

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Cytovale, a medical diagnostics company focused on providing a more rapid and insightful way to diagnose fast-moving and immune mediated diseases, today announced the publication of a study in the peer-reviewed journal Critical Care Explorations (CCE) evaluating its IntelliSep test as a tool in the rapid diagnosis of sepsis in the hospital emergency department (ED). Data from the study, "Assessment of a cellular host response test as a sepsis diagnostic for those with suspected infection in the Emergency Department," showed that Cytovale’s test is a promising tool to aid in the rapid diagnosis and risk stratification for sepsis.

In this study of patients presenting to the emergency department with signs or suspicion of infection, the authors found the IntelliSep test to be a reliable diagnostic indicator for sepsis. In addition, the study showed that the test can assist in the risk-stratification of these patients, as it correlates with severity of illness scores, the need for hospitalization and ICU care. The authors discuss that these results, coupled with the test’s rapid turnaround time (under 10 minutes) and collection in a standard, ‘purple-top’ tube, make it a potentially valuable tool for assisting ED clinicians in the efficient and effective identification and risk stratification of sepsis.

"Patients who present to the emergency department with signs or suspicion of infection need to be evaluated quickly and accurately to identify risk of sepsis so that they can be efficiently triaged and cared for," said Dr. Hollis R. O'Neal Jr., a critical care physician at the Louisiana State University Health Sciences Center and a principal investigator in the study. "This latest study evaluating Cytovale’s IntelliSep test makes a case that it is a potentially valuable tool to aid in the rapid diagnosis of sepsis in the emergency department."

The study assessed the performance of the IntelliSep test for evaluating sepsis risk in 266 adult patients who presented at emergency departments in Baton Rouge, La. with two or more Systemic Inflammatory Response Syndrome (SIRS) criteria or had blood cultures ordered. Sepsis was determined per Sepsis-3 criteria via a three-tiered, blinded, retrospective adjudication process consisting of objective review, site-level clinical review, and final determination by an independent committee.

The study showed that patients with sepsis had significantly higher IntelliSep Index (ISI) scores than those adjudicated as not septic. In addition, patients with higher ISI scores were more likely to be admitted to the hospital and show signs of increasing organ dysfunction, compared to those with lower ISI scores.

Sepsis, a dysregulated immune (white blood cell) response to infection, is often difficult to quickly and accurately diagnose. It is one of the fastest-moving, most lethal conditions in the world, and is the number one cause of death in hospitals, killing more than 270,000 people every year in the U.S. – more than opioid overdoses, prostate cancer and breast cancer combined1. Unfortunately, delays in treatment can lead to a host of catastrophic health outcomes, including collateral damage to the heart, lungs, and other organ systems, amputations, and death. Conversely, treating patients for sepsis when they do not have it taxes the health system, risks overuse of antibiotics, and may delay care for their true illness.

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. In this study, Cytovale’s IntelliSep test simply and clearly determined the risk of sepsis using a biomechanical evaluation of white blood cells from a standard blood draw, 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 thousands of leukocytes in a few seconds, yielding a score called the ISI. The ISI results are stratified into three interpretation bands corresponding to regions of low (Green Band), intermediate (Yellow Band), and high (Red Band) probability for sepsis. Detailed sepsis indications will be sought through an upcoming FDA submission following additional clinical validation, currently underway.

The results published in CCE add to the growing body of data on Cytovale’s IntelliSep test, following a peer-reviewed study published in the journal PLOS ONE showing that the ISI interpretation bands clearly distinguished mortality risk in a high-acuity population and accurately identified patients with infections severe enough to cause morbidity and mortality2.

"The results from this latest study published in Critical Care Explorations further points to the potential of our IntelliSep test as a critical, time-saving tool to change the way emergency departments everywhere recognize and treat sepsis," said Cytovale Co-founder and CEO Ajay Shah. "Coming on the heels of our previous study, which showed that IntelliSep provides clinically actionable performance in distinguishing potentially septic patients, this research adds to the mounting body of evidence that IntelliSep has the potential to change the way sepsis is diagnosed and treated."

The first patients in an FDA 510(k) clinical validation study of Cytovale’s IntelliSep test were enrolled earlier this month at clinical sites in Baton Rouge, La. and Seattle, Wa. Data from the trial, A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department Protocol (CV-SQuISH-ED), are slated to be used in Cytovale’s upcoming 510(k) clearance submission.

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Schedule30 Nov 2023