FDA Issues Two More Ebola Dx Emergency Use Authorizations

FDA Saturday (Oct. 25) issued two emergency use authorizations for Ebola diagnostics -- the BioFire Defense LLC FilmArray NGDS BT-E Assay and Biothreat-E test. The Ebola-detecting products add to three others that have received Emergency Use Authorizations in recent months. The BioFire Defense LLC FilmArray Biothreat-E test presumptively can detect Ebola Zaire -- the virus strain implicated in the West Africa outbreak -- in whole blood and urine specimens. The test must be used on the company’s FilmArray Instrument by...