A large real-world study published in the peer-reviewed journal Healthcare demonstrates that Cytovale's IntelliSep rapid sepsis diagnostic significantly reduces mortality and improves clinical outcomes in emergency department settings. The 12-month study, conducted at Our Lady of the Lake Regional Medical Center (OLOLRMC) in Baton Rouge, Louisiana, followed more than 12,000 patients and represents one of the largest real-world evaluations of a sepsis diagnostic to date.
Breakthrough Clinical Outcomes
The study revealed a 39% relative rate reduction in sepsis mortality among patients triaged using IntelliSep, while non-sepsis mortality remained unchanged, validating the diagnostic's targeted impact on sepsis care. Additionally, sepsis patients experienced a 0.76-day decrease in average hospital length of stay, with significant implications for improved throughput and cost reduction.
"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."
Enhanced Diagnostic Precision
The implementation of IntelliSep as part of a nurse-driven sepsis triage initiative demonstrated improved diagnostic precision, with a 40% decrease in blood culture usage in low-risk patients and an 8% increase in high-risk cases. This optimization reflects the diagnostic's ability to help providers fine-tune their clinical decision-making process.
IntelliSep is the first and only FDA-cleared diagnostic to aid in early sepsis detection in the emergency department. Using a routine blood draw, the test delivers results in approximately eight minutes by leveraging machine learning and advanced microfluidics to measure the dysregulated immune system response to infection that indicates sepsis.
Addressing Critical Medical Need
Sepsis represents one of the most challenging conditions in modern medicine, responsible for nearly one in three hospital deaths in the United States. Emergency departments often err on the side of caution, treating a wide range of incoming patients as potentially septic due to the lack of reliable, objective methods for early risk assessment.
"For decades, sepsis mortality rates have remained stagnant because we've lacked a fast, reliable way to catch sepsis early," said Dr. Hollis O'Neal, Medical Director of Research at OLOLRMC. "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."
Economic Impact and System Expansion
The study addresses both clinical and economic challenges associated with sepsis care. For hospitals with more than 500 beds, annual sepsis-related costs can exceed $34 million. The successful implementation at OLOLRMC, a 900-bed in-patient acute care facility and Level 1 trauma center, has led to system-wide expansion.
Reflecting confidence in IntelliSep's clinical and operational impact at scale, FMOLHS leadership has expanded the diagnostic across four additional sites within the health system. The combination of rapid diagnostic capabilities and protocolized workflow has yielded what study authors describe as a "game-changing model" for health systems nationwide.
"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."
