SAN FRANCISCO– Cytovale, a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune mediated diseases, today announced the publication of a study in the peer-reviewed journal PLOS ONE evaluating its IntelliSep test in the rapid diagnosis of sepsis in the hospital emergency department. Data from the study, “Development and validation of a cellular host response test as an early diagnostic for sepsis,” showed that Cytovale’s test has the potential to provide clinically actionable performance in distinguishing potentially septic patients.
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 combined. 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 IntelliSep Index (ISI). The ISI results are stratified into three interpretation bands corresponding to regions of low (Green Band), intermediate (Yellow Band), and high probability (Red Band) for sepsis. Detailed sepsis claims will be sought through an upcoming FDA submission following additional clinical validation.
The 473-patient study involved peripheral blood samples from three separate cohorts: a high-acuity group with a nearly 24 percent incidence of sepsis; a low-acuity group with a 6.4 percent sepsis incidence; and a group of healthy donors. In the study, the ISI interpretation bands clearly distinguished mortality risk in the high-acuity population and accurately identified patients with infections severe enough to cause morbidity and mortality. In addition, the ISI interpretation bands corresponded to the eventual diagnosis in nearly 90 percent of subjects in the Red Band and 95 percent of subjects in the Green Band, as determined by retrospective independent physician adjudication.
“Our study shows that Cytovale’s IntelliSep test identifies patients with infections severe enough to cause morbidity and mortality, and may help ED clinicians in quickly recognizing sepsis and prioritizing hospital resources to care for those most at risk for clinical deterioration and death,” 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. “IntelliSep could become an indispensable tool in triaging patients who present to the ED with possible sepsis.”
Based on this research, a subsequent prospective, multi-site study of 290 patients presenting to three U.S. emergency departments was completed and then presented at the American Association of Clinical Chemistry (AACC) meeting in December 2020. The abstract, which received the AACC Academy’s Distinguished Abstract Award for scientific excellence, showed that the IntelliSep test achieved a sensitivity of 91.5 percent, a specificity of 87.2 percent, a negative predicative value (NPV) of 97.5 percent, a positive predictive value (PPV) of 45.6 percent, and a diagnostic odds ratio (DOR) of 32.5.1
“The results from the study published in PLOS ONE continue to demonstrate the potential of our IntelliSep test to change the way emergency departments everywhere recognize and treat sepsis,” said Cytovale Co-Founder & CEO Ajay Shah. “At Cytovale, we’re focused on faster, more insightful ways to diagnose fast-moving and immune-mediated diseases, and the publication of this study is an important step toward our goal.”
