FDA-approved test can identify early sepsis

Hollis O’Neal, MD, MS

Credit: LSU Health

During the 2023 American Thoracic Society (ATS) International Conference in Washington DC, groundbreaking research evaluating an in vitro test that measures the viscoelastic properties of leukocytes as a rapid diagnostic tool for sepsis in the emergency department (ED) was presented, with insights from lead researcher 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.

HCP Live: How was the CV-SQuISH-ED multicenter clinical validation study conducted? What were the main objectives, methodologies and results 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 prospective, multi-site study involving 599 patients at four leading centers in the United States with the aim to demonstrate the performance of the IntelliSep test as a diagnostic marker for sepsis in the emergency department.

The study’s primary endpoint is a comparison to sepsis as assessed by an independent panel of physicians, the gold standard for determining sepsis. Other parameters include common disease severity and usage parameters.

The data further validates the potential of the IntelliSep test to accurately aid in the early diagnosis of sepsis in the ED when integrated into existing clinical protocols. This could give doctors actionable insights when they need it most, allowing them to quickly and confidently triage patients with suspected sepsis and spend more time with those who need it most. It also has the potential to help overburdened healthcare systems prevent unnecessary treatment, conserve valuable resources, and improve adherence to MS-1 guidelines.

HCP Live: 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 US 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, no matter who they are or where they live.

The simple, fast and intuitive test is designed for easy use in any hospital system, from dense metropolitan areas to rural hospitals, helping to close the sepsis care gap and improve health outcomes for all the patients.

The rapid test can help hospital emergency departments save lives, prevent sepsis-related morbidity and conserve resources for those who need them most. It can also help hospitals improve overall patient care and better meet guidelines set by the Centers for Medicare & Medicaid Services (CMS) for prompt treatment of sepsis known as MS-1.

For more commentary on his latest data, check out the rest of HCPLive’s interview with O’Neal.