Sepsis, the top cause of death worldwide, claims over 350,000 lives annually in the United States alone—surpassing deaths from opioid overdoses, prostate cancer, and breast cancer combined. Rapid diagnosis is crucial for survival, as every hour of delayed treatment increases the risk of death by up to 8%. Early detection, which could prevent up to 80% of these fatalities, is therefore vital to enhance clinical, operational, and financial outcomes. Now, a groundbreaking test offering quick sepsis diagnosis for adults showing infection signs and symptoms, with results in less than 10 minutes, has been released for commercial use in the U.S.

Cytovale (San Francisco, CA, USA) has rolled out its IntelliSep sepsis test in the U.S. market following its FDA 510(k) clearance in December 2022. The IntelliSep test revolutionizes diagnostics by categorizing patients into three tiers based on their sepsis likelihood from a standard blood sample. This could provide healthcare providers with a tool to enhance clinical outcomes, aid hospitals in optimizing resource use, and attain operational efficiency. Moreover, IntelliSep could help hospitals adhere to the Centers for Medicare & Medicaid Services (CMS) guidelines for prompt sepsis treatment, known as SEP-1.

Our Lady of the Lake Regional Medical Center (Baton Rouge, LA, USA), part of FMOLHS encompassing 10 hospitals, has become the first U.S. medical center to incorporate IntelliSep in its emergency department (ED). Cytovale is planning to introduce IntelliSep across the extensive FMOLHS network and its expanded clinical network. Additionally, the company is negotiating with more hospital systems across the U.S., aiming to extend the benefits of IntelliSep in early sepsis detection and patient risk stratification to more EDs seeking such a solution.

“The launch of the IntelliSep test is a huge moment in our fight against the devastating impact of sepsis,” said 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 FMOLHS hospitals.”

"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,” 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. “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.” 

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