New Study Underscores Need for Greater Objectivity and Speed in Sepsis Diagnosis and Triage

Rapid, reliable diagnostics and enhanced sepsis protocols needed to help providers quickly determine risk of sepsis and deliver effective, efficient care

SAN FRANCISCO, Dec. 6, 2023 /PRNewswire/ -- Cytovale^® today announced the publication of a new peer-reviewed study that highlights the need for its IntelliSep^® test. The study, published in "Journal of Personalized Medicine," examined healthcare provider assessments of patients' sepsis risk, which have implications on diagnosis and timely, appropriate care for this fast-moving, potentially deadly condition. The study also evaluated the impact of improved diagnostic tools, such as host response assays, in the emergency department (ED) to aid in the rapid diagnosis and risk stratification of those with suspected sepsis.

"Sepsis has a significant clinical and economic impact on hospitals, as patients often come to the ED with symptoms that may be mistaken for other conditions. The triage of potentially septic patients is complex and has historically relied heavily upon provider judgment," said Chadd Kraus, lead author of the study, who is vice chair of Research for the Department of Emergency and Hospital Medicine at Lehigh Valley Health Network and a professor at the University of South Florida Morsani College of Medicine. "Our study shows that even when presented with the same patient information, provider judgment regarding sepsis risk is highly variable, which can lead to delays in needed aggressive treatment and poor patient outcomes as well as overtreatment that results in unnecessary costs for the healthcare system."

Diverging Provider Opinions Delay Proper Care
Sepsis is one of the most deadly, costly and complex conditions. It requires quick assessment by healthcare providers since septic patients may deteriorate very quickly. Yet, sepsis is resource-intensive and difficult to detect because it presents like other conditions and requires diagnostic tests that can take critical days to deliver results. In the meantime, providers have to rely on their own judgment to determine if patients could potentially be presenting with sepsis.

In the modified Delphi study, 26 sepsis experts from multiple specialties, including emergency medicine, critical care, laboratory medicine, infectious disease and pharmacy, were asked to evaluate sepsis risk based on common case presentations. The results showed little agreement, with provider assessment of sepsis risk varying from 10% to 90% for the same case presentations.

These diverging opinions underscored the current challenges with identifying and delivering timely treatment for potentially septic patients and the need for greater objectivity to achieve better outcomes. About 80% of sepsis patients present to the ED, therefore there is a need for improved diagnostic tools, such as host response assays. These tools can aid in patient risk stratification and, when implemented in a protocolized fashion, address the variability among providers in identifying sepsis.

Risk Stratification Aids in Rapid Decision Making
Study participants also were asked to consider results from a rapid diagnostic tool, such as the IntelliSep^® host response test, which provides insights into the potential risk of sepsis based on standard blood draws in the ED. They indicated that for "borderline" patients, the additional information from this test would either validate their treatment plan or change their approach. For example, if test results indicated:

• A low probability of sepsis, providers said they would give additional consideration to alternative diagnoses.
• A high probability of sepsis, providers said they would immediately initiate aggressive sepsis-focused care.

The study showed great potential for faster diagnosis, triage and treatment of sepsis when using host response assay tools, like the recently FDA-cleared IntelliSep test from Cytovale. IntelliSep uses cell morphology to give providers unique insights about immune dysfunction, which is the fundamental mechanism of sepsis. The test then assigns patients into one of three distinct bands that assess their probability of sepsis.

"We believe IntelliSep is a valuable new tool that, when added into clinical protocols, can help providers confidently triage suspected sepsis patients, even if they do not appear to be septic, and prioritize those in greatest need," said Cytovale CEO Ajay Shah. "By supporting earlier identification of sepsis in the ED, IntelliSep has great potential to help strained health systems optimize care and patient outcomes, prevent unnecessary treatment and improve core metrics."

The case presentations and questions used in the study were developed by an independent steering committee, which also conducted the analysis. The study was sponsored by Cytovale.

About Cytovale^®
Cytovale is committed to improving human health by pioneering early detection technologies powered by insightful assessment of immune activation. Comprised of an extraordinary team of life scientists, engineers, clinicians and dreamers, Cytovale intends to accelerate the time it takes to get from triage to life-saving therapies. Learn more about Cytovale and request to implement IntelliSep^® in your hospital or care setting through cytovale.com. For updates, follow Cytovale on LinkedIn and X.

SOURCE Cytovale