Diagnostics company Cytovale recently announced the first enrollment in a clinical trial of a test to assess the potential for sepsis in the emergency department.
The Cytovale IntelliSep test is designed to provide actionable answers directly from a blood sample in under 10 minutes. The prospective study titled Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department Protocol (CV-SQuISH-ED) will involve at least 600 patients at multiple U.S. health centers, according to San Francisco-based Cytovale. Its 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 first patients were enrolled at Our Lady of the Lake Regional Medical Center in Baton Rouge, La., and Harborview Medical Center in Seattle, Wash. Other enrolling centers will include University of Missouri Health Care in Columbia, Mo., and Wake Forest Baptist Health in Winston-Salem, N.C.
“Early and reliable strategies to identify sepsis remain elusive, complicating physicians’ efforts to implement sepsis care as quickly as possible. Since time-to-treatment for sepsis is measured in lives saved, we need a tool to mitigate diagnostic uncertainty and facilitate early sepsis care,” said Dr. Daniel Henning, a University of Washington emergency medicine physician and site principal investigator at Harborview Medical Center, in a news release. “CV-SQuISH-ED, the latest trial evaluating this type of novel early detection sepsis testing, may give us exactly that kind of tool.”
Sepsis is the number one cause of death in hospitals, taking the lives of 270,000 people every year in the U.S. alone – more than opioid overdoses, prostate cancer, and breast cancer combined, according to a 2014 study published in JAMA. Mortality from sepsis increases as much as 8% with every hour of delayed treatment, and as many as 80% of septic shock patients survive with early identification and initiation of appropriate antibiotics, according to a separate study published in the journal Critical Care Medicine.
The clinical validation study builds on two previous studies of Cytovale’s IntelliSep test. “We are hopeful that CV-SQuISH-ED will confirm the findings of our previous work with this important technology,” said Dr. Hollis O’Neal, critical care physician at Louisiana State University Health Sciences Center and national principal investigator for the study. “Sepsis takes a heavy toll on our patients and a tool like this could make a big difference.”
