ICU-Level Care Not Definitive Indicator for Sepsis, New Study Shows

• A majority (57%) of septic patients did not meet criteria for ICU level of care 
• 30% of sepsis-associated deaths occurred in patients who did not meet the criteria of ICU level of care
• Cytovale's IntelliSep^® host-response test was shown to be superior in both sepsis detection and prognosis when compared to a measurement of ICU level of care

SAN FRANCISCO and LAS VEGAS, April 22, 2025 /PRNewswire/ -- A retrospective analysis of an observational study being presented this week at the Society of Hospital Medicine (SHM) Converge conference reveals that the need for intensive care unit (ICU)-level care in patients with suspected infection is not a definitive indicator for sepsis. "Prognostic Ability of Cellular Host Response Test in Diagnosis and Risk Stratification of Patients with Suspected Infection in Need of ICU-Level Care" details a five-year analysis of suspected infection patients at Our Lady of the Lake Regional Medical Center (OLOLRMC) in Baton Rouge, La. In comparing ICU level of care (LOC) to results of a cellular host-response test to stratify septic patients, researchers found that ruling out sepsis based on ICU level of care would have missed 57% of the patients who were ultimately diagnosed as sepsis.

"Sepsis is a fast-progressing condition that mimics other diseases and can be deadly if not addressed quickly and properly," said pulmonary and critical care physician Robert Scoggins, MD, PhD at Kootenai Health. "Simply knowing that a patient is in need of ICU resources – such as ventilation, renal replacement therapy or vasopressors – tells you nothing about the cause of their condition. In fact, using emerging tools that correlate with ICU level of care likely provides limited value beyond measuring patients' lactate level. There are more accurate ways to determine risk of sepsis. Specifically, there is a U.S. Food and Drug Administration (FDA)-cleared cellular host-response test that enables clinicians to more accurately risk-stratify patients, ensuring they get the proper disease-specific treatments and ultimately improving outcomes."

Accurate and timely detection requires a specific test for sepsis
Sepsis is a dysregulated host immune response to infection that leads to life-threatening organ dysfunction and is the leading cause of in-hospital death. Most cases present initially to emergency departments (EDs), but symptoms, including fever, rapid heart rate and breathing, and low blood pressure, are not specific to sepsis. This makes diagnosis difficult, particularly in the early stages, which can impact patient outcomes. The risk of death increases by up to 8% for each hour that septic shock treatment is delayed, while treating non-septic patients for sepsis can result in further medical complications and death.

This retrospective study compared the accuracy of ICU LOC and a cellular host-response test (IntelliSep^®) to determine which risk stratification approach is most accurate in predicting sepsis using data from 730 adult patients with suspected infection who presented to the ED. Researchers demonstrated in this study that:

• If a provider used "no need for ICU LOC" as an indicator to rule out sepsis, 57% of patients who went on to develop sepsis would have been missed and 30% of sepsis deaths were in this subpopulation.
• If a provider used IntelliSep Band 1 as an indicator to rule out sepsis, only 5% of patients who went on to develop sepsis would have been missed and 0 sepsis deaths were in this subpopulation.

"Doctors on the front lines need tests to aid in rapid decision making. We have these for stroke and heart attack, allowing us to quickly determine what's wrong and put patients on the right path," said Hollis "Bud" O'Neal, MD, MSc, associate professor of Medicine at Louisiana State University Health Sciences Center and medical director of research for OLOLRMC, who was one of the authors of the study. "Cellular host-response tests are filling this void for determination of sepsis, helping us accurately assess both the potential risk and severity of sepsis for patients in critical condition and determine the proper course of treatment."

OLOLRMC is leveraging Cytovale®'s IntelliSep, the first and only U.S. Food and Drug Administration (FDA)-cleared cellular host response diagnostic indicated for use as an aid in the early detection of sepsis within the Emergency Department (ED). Within the first year of IntelliSep use, OLORMC reported significant clinical improvements, including improved patient outcomes with lower mortality rate for sepsis patients, faster treatment and shorter hospital stays.

"Because IntelliSep provides a metric of immune dysregulation, it may provide superior and more actionable risk-stratification information for the management of potentially septic patients than using ICU LOC," said Dr. O'Neal.

This study (Abstract 278) will be presented during SHM Converge on Wednesday, April 23 at 12:10 p.m., Screen F, Converge Central (Oceanside A) at the Mandalay Bay Resort and Casino in Las Vegas.

About Cytovale^®
Cytovale is committed to improving patient care by pioneering early detection technologies that assess immune activation to accelerate the time it takes to get from triage to life-saving therapies. Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, IntelliSep^®, leverages machine learning and advanced microfluidics to provide Emergency Department clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep measures the dysregulated immune system response to infection that would indicate sepsis and generates results in about eight minutes using a standard blood draw. Cytovale is based in San Francisco and venture-backed by Norwest Venture Partners, Sands Capital and Global Health Investment Corporation (GHIC). For more information, visit www.cytovale.com and follow Cytovale on LinkedIn and X.

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SOURCE Cytovale