Peer-Reviewed Study Shows IntelliSep Influences ED Physicians' Sepsis Diagnostic Decisions

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New multicenter analysis highlights IntelliSep's clinical usability and impact on frontline physician decision-making, strengthening existing real-world evidence

SAN FRANCISCO, March 30, 2026 /PRNewswire/ -- A new peer-reviewed study published in JACEP Open found that providing emergency department (ED) physicians with IntelliSep^® sepsis test results was associated with improved diagnostic accuracy and confidence when evaluating patients for sepsis. In the multicenter, vignette-based study, diagnostic decisions were changed or reinforced in 86% of cases when IntelliSep results were added to standard ED clinical data. Participating physicians had no prior experience with IntelliSep and received brief training before integrating the test results into their evaluations.

"Emergency physicians need diagnostic tools that are sensitive and intuitive as well as actionable in real time," said study co-author Chadd K. Kraus, DO, DrPH, FACEP, a practicing emergency physician and researcher with expertise in sepsis diagnostics. "The results of this study suggest that clinicians were able to quickly understand and rapidly apply the IntelliSep stratification for sepsis risk, and that those results helped inform timely initiation of additional diagnostic tests and treatments in the emergency department."

This decision-impact analysis complements previously reported real-world implementation data evaluating patient outcomes and emergency department operations following IntelliSep adoption. While prior studies assessed system-level impact, this research focuses specifically on physician diagnostic behavior, providing additional validation of IntelliSep's clinical usability in routine emergency care.

Measured Impact on Clinical Decision Making

This prospective, multicenter study, Impact of a Cellular Host-Response Sepsis Diagnostic on Clinical Decision-Making in the Emergency Department: A Vignette-Based Study, evaluated physician decision-making using 100 patient vignettes collected at four U.S. hospitals. A total of 52 physicians completed 1,040 case evaluations, first reviewing standard ED data – including vital signs, comorbidities and symptoms, and routine laboratory results – and then reviewing cases with the addition of IntelliSep results.

Key findings include:

• Decision impact: Physicians reported that IntelliSep results either changed or reinforced their diagnostic decisions in 86% of cases, particularly among higher-risk patients in which missing sepsis can be fatal.
• Improved diagnostic accuracy: Access to IntelliSep results was associated with greater accuracy in identifying and ruling out sepsis compared to standard clinical data alone.
• Increased provider confidence: Physicians reported a 19% relative increase in diagnostic confidence (from 53.1% to 63.1%) when IntelliSep results were available.
• Ease of interpretation with minimal training: Physicians with no prior experience using IntelliSep were able to quickly understand and apply results after brief training.

"Emergency medicine clinicians get inundated by all of the tests and notifications that occur throughout a shift," said study author Thomas Carver, MD, FACS, Professor of Surgery at the Medical College of Wisconsin and Senior Medical Director of Critical Care Services at Froedtert Hospital. "IntelliSep can be a signal in the noise. Having this rapid, reliable test can improve physicians' diagnostic confidence and change their approach to sepsis, offering a more accurate way to assess patient risk."

About IntelliSep^®
IntelliSep is Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, which leverages artificial intelligence (AI) and advanced microfluidics to provide Emergency Department clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep assesses the body's dysregulated immune system response to infection and provides a risk score for sepsis within approximately eight minutes using a standard blood draw. For more information, visit cytovale.com/our-solution/intellisep-sepsis-test/.

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 developed IntelliSep® the U.S. Food and Drug Administration-cleared rapid sepsis diagnostic for use with a standard blood draw in Emergency Departments to determine risk of sepsis. 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 cytovale.com and follow Cytovale on LinkedIn.

SOURCE Cytovale