IntelliSep® is the first FDA-cleared diagnostic tool to assess cellular host response to aid in identifying emergency department patients with sepsis and contribute to rapid life-saving decisions

Cytovale®, a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced today that its IntelliSep® test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year.

IntelliSep is a groundbreaking diagnostic tool that helps clinicians recognize sepsis and supports critical time-sensitive clinical decisions, providing test results in under 10 minutes. The first in a new class of ED-focused diagnostic tools that assess host response, the test is a simple, fast, and intuitive solution that provides actionable answers directly from a standard blood draw. IntelliSep categorizes patients into three bands according to their probability of sepsis, with Band 1 indicating low probability of sepsis and Band 3 indicating high probability of sepsis… Continue reading.