Cytovale's Rapid Diagnostic Slashes Sepsis Mortality by 39%, Peer-Reviewed Study Confirms

• Cytovale's IntelliSep^® sepsis test highlights a new model for ED triage that's already delivering systemwide clinical and economic value
• Results of real-world study with 12,000+ patients published in the journal Healthcare

SAN FRANCISCO, June 12, 2025 /PRNewswire/ -- One of the largest real-world studies of a sepsis diagnostic reveals that Cytovale's IntelliSep^®, a U.S. Food and Drug Administration (FDA)-cleared rapid host response diagnostic, reduced the relative rate of sepsis mortality by 39%, shortened length of hospital stay and enabled more efficient resource allocation in the emergency department (ED). The study, "Impact of a Sepsis Quality Improvement Initiative on Clinical and Operational Outcomes," published in the peer-reviewed journal Healthcare, followed more than 12,000 patients over 12 months at Our Lady of the Lake Regional Medical Center (OLOLRMC), a 900-bed in-patient acute care facility and Level 1 trauma center in Baton Rouge, La.

"This is the kind of data the medical field has been waiting for and the results represent a breakthrough in sepsis care," said Dr. Christopher Thomas, study author who serves as Vice President and Chief Quality Officer at Franciscan Missionaries of Our Lady Health System (FMOLHS) and is a critical care physician at Louisiana State University Health Sciences Center. "With this small operational change, we are able to save more lives, deliver better care faster and optimize use of hospital resources. It's a pivotal step forward in how emergency departments manage sepsis. With IntelliSep, we've discovered a new way to save lives."

Key Study Findings

• 39% relative rate reduction in sepsis mortality, with non-sepsis mortality unchanged, validating the impact of IntelliSep on targeted triage.
• 0.76 day decrease in average hospital length of stay for sepsis patients, with strong implications for improved throughput and cost reduction.
• 40% decrease in blood culture usage in low risk patients and an 8% increase in high-risk cases, underscoring the ability of IntelliSep to help providers fine-tune diagnostic precision.

Detecting Sepsis in Minutes, Bringing Speed and Confidence to the Frontline
Sepsis is one of the most elusive and deadly conditions in modern medicine, responsible for nearly one in three hospital deaths in the United States. EDs often err on the side of caution, treating a wide range of incoming patients as potentially septic because there is a lack of reliable, objective methods for early risk assessment.

Treating every patient as potentially septic, while understandable in a high-stakes environment like the ED, often results in unnecessary, non-beneficial interventions for patients who likely do not have sepsis. The strains on limited ED resources was a top concern for OLOLRMC when it implemented IntelliSep as part of a nurse-driven sepsis triage initiative designed to identify and rapidly triage patients at highest risk. 

IntelliSep is the first and only FDA-cleared diagnostic to aid in early sepsis detection in the ED. Using a routine blood draw, the test delivers results in about eight minutes. This helps clinicians to rule in or rule out sepsis even before clinical signs are fully visible, giving them greater confidence to determine which patients are in most urgent need of care. The combination of a rapid diagnostic and a protocolized workflow has yielded what the study authors describe as a "game-changing model" for health systems nationwide.

"This is more than an innovation – it's a paradigm shift in how health systems are managing sepsis," said Dr. Hollis O'Neal, Medical Director of Research at OLOLRMC. "For decades, sepsis mortality rates have remained stagnant because we've lacked a fast, reliable way to catch sepsis early. This study proves that with speed, objectivity and accuracy at the point of triage, we can change outcomes before antibiotics are given or ICU beds are needed. That's where real transformation begins."

Validated in One Hospital, Scaled Across the Health System
Sepsis is not just a clinical challenge, it's a financial one. For hospitals with more than 500 beds, annual sepsis-related costs can exceed $34 million. 

A bet on a new approach to sepsis care paid off for OLOLRMC. Reflecting its confidence in IntelliSep's clinical and operational impact at scale, the system's leadership has expanded IntelliSep across four additional sites within FMOLHS.

"As health systems face mounting pressures to deliver efficient, effective care, adopting this precise, rapid method will be key to saving lives and controlling costs," Dr. Thomas added. "Those who embrace this approach position themselves at the forefront of sepsis care innovation."

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.

SOURCE Cytovale