Cytovale Initiates Enrollment for Trial of Rapid Sepsis Test

June 3, 2021

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.

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