Cytovale Initiates Enrollment for Trial of Rapid Sepsis Test

Cytovale has initiated patient enrollment in a clinical validation study for its IntelliSep rapid sepsis test.

The multisite prospective study will enroll a minimum of 600 patients and will evaluate the test’s performance as a diagnostic marker of sepsis in the emergency room.

Cytovale said that data accrued from the trial will be included in its 510(k) submission to the FDA for the sepsis test.