Cytovale's Rapid Sepsis Test Drives 56% Increase in ED Discharges Without Compromise to Patient Safety, Study Finds

Multicenter study shows IntelliSep^® enables an increase in safe ED discharges, easing
inpatient bed shortages without increasing 30-day return visits

SAN FRANCISCO and CHICAGO, July 29, 2025 /PRNewswire/ -- New multicenter study data reveals that targeted sepsis testing at triage in the ED may be key to preserving inpatient bed capacity for the most severe patients. Cytovale's rapid sepsis diagnostic IntelliSep^® drove a 56% relative increase in ED discharges among low risk patients and lowered inpatient bed utilization, without increasing the rate of return visits. Study results underscore that smarter sepsis decision making at triage can directly impact hospital capacity by increasing safe discharge decisions.

The study, being presented tomorrow at the 2025 Association for Diagnostics & Laboratory Medicine (ADLM) Clinical Lab Expo, evaluated 4,650 patients with signs and symptoms of infection tested with IntelliSep over the course of four months at four hospitals in the Franciscan Missionaries of Our Lady Health System in Louisiana and Mississippi. When used early in triage, IntelliSep's risk stratification and decision making insights helped clinicians reduce unnecessary admissions and discharge patients with greater confidence.

Key study findings:

• 56% relative increase in ED discharge rate for patients classified as low sepsis risk (IntelliSep Band 1)
• No significant change in ED 30-day return rates, underscoring patient safety was uncompromised

"Improving quality of care in the ED required our health system to tackle sepsis – a time-sensitive condition that can be deadly if not addressed quickly. Rapid diagnostics like IntelliSep help our team make better treatment decisions," said Dr. Christopher Thomas, Vice President and Chief Quality Officer at FMOLHS and critical care physician at LSU Health Sciences Center. "By ruling out sepsis for low-risk patients, we're reducing avoidable admissions and creating bed capacity for critically ill patients."

Tackling Sepsis to Support Smarter Triage, Safer Discharges
Annually there are more than 155 million ED visits nationwide, with about 20% of adults presenting with a potential serious infection. Identifying which of these patients have sepsis – and which do not – remains one of the most consequential decisions emergency clinicians face. When every minute counts, the ability to quickly and accurately rule out sepsis can shape not only patient outcomes, but also care quality, financial sustainability and overall system efficiency.

Meanwhile, ED crowding continues to strain hospital resources and impact patient satisfaction. In a 12-month period, average ED boarding times have risen from 167 to 175 minutes and the rate of patients who leave without being seen has climbed from 1.1% to 2.1%, risking patient safety. In this environment, overly cautious admissions for suspected sepsis, while well-intentioned, can exacerbate overcrowding and delay care for others, including those who are truly septic.

IntelliSep's rapid host-response test is helping drive more confident decision making by aiding in rapid identification of patients' risk of sepsis. The test, which takes approximately eight minutes from blood to result, can be used in ED triage with a standard blood draw to risk stratify patients. The results enable clinicians to have greater confidence in who they can safely discharge and who requires urgent intervention and potential admission.

"This study underscores how IntelliSep enables ED teams to act with clarity when treating patients suspected of having sepsis," said Bradley Burns, MD, Emergency Medicine Medical Director at St. Dominic Hospital and co-author of the study. "With IntelliSep, we're not only able to make decisions faster, but we are also able to treat more confidently, clearing a path through the ED that enhances patient safety, allows judicious use of resources, and focuses our clinical response."

For more details, download the study, "Effect of Early-Stage Protocolized Implementation of a Novel Host-Response Test on Discharges, Hospital Free Days, and Returns at Four EDs in a Health System."

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 www.cytovale.com and follow Cytovale on LinkedIn and X.

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SOURCE Cytovale