FilmArray BioThreat-E Test regulatory update

FDA granted emergency use authorization (EUA) for the FilmArray BioThreat-E Test from bioMerieux's BioFire Defense LLC subsidiary to diagnose Ebola Zaire virus in patients with signs and symptoms of the disease from whole blood and urine samples. The in vitro multiplex PCR platform runs on the BioFire FilmArray system, delivers results in 1 hour and is available to CLIA-certified labs of moderate and high complexity. The company developed the Ebola test with the U.S. Department of Defense. ...