Cytovale Demonstrates 8-Minute Sepsis Diagnostic Test

By LabMedica International staff writers
Posted on 01 Aug 2024

Image: The FDA-cleared IntelliSep sepsis test and Cytovale System can be seen in action at ADLM 2024 (Photo courtesy of Cytovale)

Cytovale (South San Francisco, CA, USA) is exhibiting at the ADLM 2024 Clinical Lab Expo where the company is demonstrating its FDA-cleared IntelliSep sepsis test, which processes samples in around 8 minutes.

Visitors to the Cytovale booth can also see the Cytovale System in action. With cutting-edge host response technology, the IntelliSep sepsis test along with the Cytovale System provides laboratory professionals with sepsis risk stratification results in ~8 minutes, enabling teams in the Emergency Department (ED) to make timely, life-saving decisions. The IntelliSep test is the only test of its kind that is U.S. Food and Drug Administration (FDA)-cleared for detecting sepsis in an adult population that presents with signs and symptoms of infection to the ED. The test provides critical new information about immune activation and sepsis risk stratification through a simple blood draw in about 8 minutes.

A recent large-scale study confirmed that Cytovale's IntelliSep test accurately predicts sepsis risk and severity, and aids in appropriate triage and treatment pathways in the ED. The study analyzed 1,002 patients and evaluated the accuracy of IntelliSep to rapidly diagnose patients with sepsis and help clinicians expedite appropriate care. IntelliSep demonstrated impressive 'rule-out' performance related to sepsis, with a negative predictive value of 97.5%, which, combined with the 0.0% sepsis mortality rate for patients with low-risk scores, may allow the care team to explore alternative diagnoses in low-risk patients. The test showed similar 'rule-in' performance to other critical ED tests, with a positive predictive value of 55%. The Cytovale System which can be seen in action at the show interrogates thousands of cells per second to rapidly assess host immune state and identify disease signatures. A simple workflow with minimal hands-on time provides clinicians with actionable information in under 10 minutes to aid in diagnosis and inform treatment.

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