Cytovale, a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced the U.S. commercial launch of the IntelliSep sepsis test following FDA 510(k) clearance in December 2022. 

Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, is the first U.S. medical center to adopt IntelliSep for emergency department (ED) use. The test aids in the rapid diagnosis of sepsis for adult patients with signs and symptoms of infection, providing results in under 10 minutes.

“Sepsis is one of the most common conditions impacting emergency departments in the United States, and there has not been a timely test to identify sepsis early until now,” says 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. “With the IntelliSep test, we can deliver the right care to the right patients at the right time and we are excited to be the first hospital in the country to implement this technology. I’m really excited for what the future brings.”

What is the IntelliSep Sepsis Test?

The IntelliSep test is a diagnostic tool that categorizes patients into three bands according to their probability of sepsis based on a standard blood draw. The results may equip providers with a tool to optimize clinical outcomes and empower hospitals to improve resource utilization and achieve operational excellence. IntelliSep may also support hospital efforts to meet guidelines set by the Centers for Medicare & Medicaid Services (CMS) for timely sepsis treatment, known as SEP-1.

Sepsis is the leading cause of death worldwide and is responsible for more than 350,000 deaths every year in the United States alone—more than opioid overdoses, prostate cancer, and breast cancer combined. (1,2) Quickly recognizing sepsis is critical to saving lives because the risk of death can increase by as much as eight percent each hour the condition is undiagnosed and untreated. As many as 80% of these deaths could be prevented with rapid diagnosis and treatment – making early detection critical to improving clinical, operational, and financial outcomes. (1)

Further reading; Rapid Diagnostic Test for Sepsis Validated for Emergency Department

“The launch of the IntelliSep test is a huge moment in our fight against the devastating impact of sepsis,” says Cytovale co-founder and CEO Ajay Shah. “We know early detection and diagnosis is key, and we’re proud to have a partner in Our Lady of the Lake and look forward to seeing IntelliSep’s impact at other Franciscan Missionaries of Our Lady Health System (FMOLHS) hospitals.”

Our Lady of the Lake Health is part of FMOLHS, which includes 10 hospitals across Louisiana and Mississippi. Cytovale is working to launch IntelliSep across the broader FMOLHS network and an expanded clinical network through the health system’s partnership with Louisiana State University. 

The company is also in discussions with additional hospital systems across the U.S. so that the impact of IntelliSep on early sepsis identification and patient risk stratification may be extended to additional emergency departments seeking such a solution.

Photo: The IntelliSep sepsis test courtesy of Cytovale


1. What Is Sepsis?, Sepsis Alliance (2022) 

2. Sepsis Awareness Study Summary Report, Radius Global Market Research (2019).