Cytovale, a medical diagnostics company, announced that its IntelliSep® test received FDA clearance, aiding clinicians in early detection of the No. 1 cause of death in hospitals: sepsis. 

Much of the research and clinical studies for this new technology took place right here in Baton Rouge, at Our Lady of the Lake Regional Medical Center and its Emergency Department. Since 2015, Our Lady of the Lake has partnered with Cytovale on more than half a dozen studies that led to this groundbreaking tool.  

Louisiana has the highest rate of sepsis mortality in the country, according to the Centers for Disease Control and Prevention, which makes the partnership between Our Lady of the Lake Health and Cytovale that much more crucial. 

“Early detection of sepsis is an invaluable capability for healthcare professionals. Quickly identifying sepsis is critical to saving lives, but until now, we’ve lacked a reliable tool to either recognize the condition or explore alternate diagnoses,” said Hollis O’Neal, MD, medical director of research at Our Lady of the Lake Regional Medical Center and critical care physician at LSU Health Sciences Center. O’Neal was also the national principal investigator on the multi-center study that supported the clearance. 

The IntelliSep test examines blood samples taken from patients as they enter the emergency room to see if white blood cells behave in a certain way that would indicate a septic or non-septic patient. In under 10 minutes, the test provides results that can empower emergency department teams with the means for time-sensitive decision-making and life-saving outcomes. 

Sepsis happens when the immune system overreacts to a serious infection, attacking more than just the infection itself. If not treated early enough, it can result in tissue damage, organ failure and death. Sepsis is the leading cause of death worldwide and responsible for more than 270,000 deaths every year in the United States, according to the Sepsis Alliance. 

Healthcare costs in the United States associated with the diagnosis and treatment of sepsis amount to $62 billion a year. Healthcare professionals in emergency departments operate under intense pressure to quickly assess medical needs, and until now there has been no timely “gold standard” test to identify sepsis early, leading to the possible misallocation of medical resources and the overuse of antibiotics. 

“IntelliSep is truly a game changer,” said O’Neal. “The test provides hospital staff with information needed to identify and treat septic patients efficiently and reduce the financial and health burdens of overtreatment for hospitals and patients.”

Our Lady of the Lake Health’s research in partnership with Cytovale dates to the very first studies conducted to model the IntelliSep test. In fact, the first patients to be tested using the diagnostic tool were patients at Our Lady of the Lake Regional Medical Center.  

Cytovale’s research utilized resources shared with LSU, Our Lady of the Lake Health’s Championship Health Partner. Innovative research is one of the pillars of the LSU partnership, advancing medical research and clinical treatment to address significant health issues around Louisiana and making Baton Rouge a nationally recognized hub of research excellence. 

“You have to have an excellent clinical partner to create this kind of success. Our research and laboratory teams have provided that environment for Cytovale,” said Christopher B. Thomas, MD, medical director of quality and patient safety for Franciscan Missionaries of Our Lady Health System and critical care physician at LSU Health Sciences Center. “To be part of this journey from beginning to end speaks to our clinical excellence as well as our diverse team of top-tier researchers who lend their expertise to some of the premier research institutions in the country.” 

IntelliSep is expected to be available to healthcare facilities in early 2023 and Our Lady of the Lake will be among the first to implement the technology as part of its sepsis learning health platform, aiding in the recognition and treatment of patients at Our Lady of the Lake Regional Medical Center’s Emergency Department. 

“Our Lady of the Lake Health is excited to have contributed to this breakthrough technology. This goes to our core mission as a Catholic health system to care for those most in need when they come into our emergency departments,” said Chuck Spicer, president of Our Lady of the Lake Health. “Cytovale’s innovative technology will help drastically decrease the number of sepsis-related deaths in hospital settings, and we are honored that, since day one, we have been a part of the research that led to this technology. It speaks to the expertise of our incredible research team at Our Lady of the Lake Health that we were able to provide key insights and on-site research work for the IntelliSep test.”