New Data Reveals Path to SEP-1 Success Includes Early Sepsis Risk Stratification

Study reveals how Cytovale's IntelliSep^® sepsis test enables early sepsis risk stratification and more precise documentation, increasing SEP-1 compliance by 29%

SAN FRANCISCO and SALT LAKE CITY, Sept. 7, 2025 /PRNewswire/ -- A new study presented at the American College of Emergency Physicians (ACEP) conference today reveals how Our Lady of the Lake (OLOL) Regional Medical Center in Baton Rouge, La., achieved a double-digit increase in SEP-1 quality metric performance by integrating Cytovale's IntelliSep^® rapid host response sepsis test with appropriate electronic health record (EHR) documentation into its emergency department (ED) protocol.

The study highlights how the IntelliSep sepsis test empowers clinicians to identify sepsis earlier—often before traditional clinical criteria are met—and avoid overtreatment of patients unlikely to benefit from sepsis interventions. By providing a first-ever look at the dysregulated immune response to infection that leads to sepsis, this innovative solution may offer a roadmap for hospitals and health systems nationwide seeking to boost compliance with the Centers for Medicare & Medicaid Services (CMS) SEP-1 quality measure.

"Unlike traditional approaches that may boost SEP-1 performance by broadly applying sepsis protocols—often at the cost of overtreatment—we integrated IntelliSep into our sepsis protocol to gain objective insight into sepsis risk, ensuring we deliver the SEP-1 bundle to the right patients from the start," said Dr. Christopher Thomas, study Co-Author who is Vice President and Chief Quality Officer at Franciscan Missionaries of Our Lady Health System and Critical Care Physician at Louisiana State University Health Sciences Center. "This approach yielded significant results, enabling OLOL to achieve meaningful compliance gains in a short time. IntelliSep is a key to helping hospitals exceed compliance minimums while optimizing patient-centered care."

The study assessed the impact of integrating IntelliSep into clinical and documentation workflows on SEP-1 compliance using data from 598 patients discharged with sepsis ICD-10 codes. OLOL, a high-performing hospital already exceeding national SEP-1 compliance benchmarks, reported a 28.9% relative increase in SEP-1 performance over a six-month period, rising from 61.2% in July 2024 to 78.9% in December 2024. The hospital achieved these dramatic improvements using an innovative sepsis protocol that involves:

• Objective insight into sepsis risk with an ~8-minute sepsis lab test that supports timely, patient-centered care at the time of triage
• Empowering clinicians to confidently intervene with sepsis treatment for high-risk patients and pursue alternative care pathways for those at low risk
• Improved early EHR documentation with dot phrases referencing the FDA-cleared IntelliSep test for early sepsis detection—providing an easy, effective way to communicate when the SEP-1 bundle should or shouldn't apply

This study provides further evidence that IntelliSep enables hospitals to improve patient care and optimize resource utilization while meeting SEP-1 guidelines. In a separate study published earlier this year in the peer-reviewed journal Healthcare, OLOL lowered the relative rate of sepsis mortality by 39%, shortened length of hospital stay for sepsis patients by 0.76 days, decreased Code Sepsis alerts by 80%, and enabled more efficient resource allocation in the ED by reducing blood cultures ordered for IntelliSep Band 1 (low-risk) patients by 40%.

Aligning SEP-1 with Patient-Centered Care
SEP-1 reporting is mandatory and performance is tied to CMS Value-Based Purchasing (VBP). With financial penalties and incentives now in-effect, hospitals across the U.S. face growing pressure to both meet compliance standards and deliver patient-centered care.

Strategic integration of host response testing, like IntelliSep, into sepsis protocols can drive both clinical and operational gains. By aligning diagnostics with documentation, hospitals can improve quality metric performance without over overtreating.

"The clinical criteria for the SEP-1 bundle may not always support identification of sepsis early on in the progression of disease," said Dr. Hollis O'Neal, Medical Director of Research at OLOLRMC. "IntelliSep, which looks at a patient's immune dysregulation, has been a critical tool in helping us quickly identify patients during our initial ED triage who otherwise didn't 'look septic.' That early identification helps us not only deliver timely care to the right patients, but also document the risk of sepsis clearly so we receive credit from CMS—all while reducing unnecessary use of blood cultures and other resource-intensive diagnostics."

For more details download the study, "Investigation of the Effect of Implementing a Host Response Test on SEP-1 Compliance."

About IntelliSep
IntelliSep^® is Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic test, 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