Late-breaking data validates the FDA clearance of Cytovale's IntelliSep test, demonstrating its potential to aid in the early detection of sepsis in US emergency departments, with the aim of improving patient outcomes.
During the American Thoracic Society (ATS) 2023 International Conference in Washington DC, groundbreaking research evaluating an in-vitro test that measures leukocytes' viscoelastic properties as a rapid sepsis diagnostic tool in the emergency department (ED) was presented, featuring insights from lead investigator Hollis O'Neal, MD, MSs, associate professor of medicine and director of research at OLOLRMC, Louisiana State University Health Sciences Center, shared in an email interview with HCPLive.
HCPLive: How was the multi-center CV-SQuISH-ED clinical validation study conducted? What were the key objectives, methodologies, and outcomes of the study?
Hollis O'Neal: The trial, A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department Protocol (CV-SQuISH-ED), is a multi-site, prospective study involving 599 patients at four leading centers across the U.S. with the objective to demonstrate the performance of the IntelliSep test as a diagnostic marker of sepsis in the ED.
The study’s primary endpoint is a comparison to sepsis as adjudicated by an independent panel of physicians, the gold standard for sepsis determination. Other endpoints include common severity of illness and utilization metrics.
The data further validates the potential of the IntelliSep test to accurately aid in the early diagnosis of sepsis in the ED when incorporated into existing clinical protocols. This could give physicians actionable information when they need it most, allowing them to confidently triage suspected sepsis patients quickly and spend more time with those in greatest need. It also has the potential to help strained health systems prevent unnecessary treatment, preserve valuable resources and improve compliance with SEP-1 guidelines.
HCPLive: The FDA granted 510(k) clearance for Cytovale's IntelliSep test in December 2022. Can you elaborate on the significance of this clearance and its impact on the early detection of sepsis in U.S. emergency departments?
Hollis O'Neal: Sepsis knows no bounds and affects all backgrounds, races, and ethnicities equally. IntelliSep has the power to impact the lives of hundreds of thousands of patients, regardless of who they are or where they live.
The simple, fast, and intuitive test is designed for easy use at any hospital system, from dense metropolitan areas to rural hospital settings, helping close the gap in sepsis care and improve health outcomes for all patients.
The rapid test may aid hospital EDs in saving lives, preventing sepsis-related morbidity, and conserving resources for those who need it most. It may also assist hospitals in improving overall patient care and better meet guidelines set by the Centers for Medicare & Medicaid Services (CMS) for timely sepsis treatment known as SEP-1.