US Food and Drug Administration (FDA) 510 (K) rendered clearance of Intellisep on the 5th of January this year, as part of its December 2022 decisions. Intellisep is Cytovale’s groundbreaking diagnostic tool for early sepsis detection. It is claimed to be the first FDA-cleared diagnostic tool to assess cellular host response for emergency patients with sepsis in under 10 minutes.
Sepsis is a leading cause of death in hospitals, affecting at least 1.7 million adults and is responsible for nearly 270,000 deaths in the United States every year. Sepsis is characterized by eventual tissue damage and organ failure in response to an infection. Risk of death in sepsis increases by 8% for every hour that the condition remains untreated. With Intellisep, clinicians will be assisted to recognize sepsis faster to make time-sensitive and critical decisions for treatment.
Intellisep is designed using a biomechanical evaluation of white blood cells collected from a standard blood draw to determine cellular host response and its probability of sepsis. The test result is categorized into three: Band 1 indicates low probability and it can increase to Band 3 showing a high probability of sepsis. The new diagnostic tool is expected to improve clinical, operational, and financial outcomes through efforts of early detection and timely sepsis treatment.
Source: Cytovale's website | cytovale.com“IntelliSep is truly a game changer for sepsis because it provides a unique indicator that gets to the heart of the current sepsis definition, immune dysregulation. The test provides hospital staff with the information needed to identify and treat septic patients efficiently and reduce the financial and health burdens of overtreatment for hospitals and patients”, says Hollis O’Neal, Director of Research at Our Lady of the Lake Regional Medical Center, Critical Care Physician at LSU Health Sciences Center, and National Principal Investigator on CV-SQuISH-ED study that supported the clearance.
The CV-SQuISH-ED study is a multicenter clinical validation study that completed the evaluation of Intellisep in early 2022. Data showed the efficacy of the 10-minute test’s to potentially aid in the rapid identification of patients with increased risk of sepsis.
“This clearance is a pivotal step forward in Cytovale’s commitment to early detection technologies to improve health… IntelliSep has the potential to transform clinical approaches to sepsis triage and diagnosis and save countless lives”, says Cytovale co-founder and CEO Ajay Shah.
Cytovale’s Intellisep will be commercially available across the United States in the coming weeks.
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