BioFire Defense, LLC announced today that it has received Emergency Use Authorization by the U.S. Food and Drug Administration for its commercial FilmArray Ebola test (BioThreat-E test) as well as a second Ebola test to be used by laboratories designated by the Department of Defense. The FilmArray BioThreat-E is the first commercial Ebola test to be authorized for emergency use on patients with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors.
The BioFire FilmArray system is a clinical molecular biology (PCR) diagnostic device. The BioFire FilmArray system, which has previously been cleared by FDA, is capable of identifying hundreds of the most prevalent viruses, fungi, bacteria, and parasites associated with common patient infectious disease syndromes in one hour allowing health professionals to make treatment decisions faster. “The FilmArray system is in routine use in over 300 hospitals.
The commercial BioThreat-E test is available to high and moderate complexity clinical laboratories in the US and can be run on any existing BioFire FilmArray system.
* This test has not been FDA cleared or approved;
* This test has been authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) and not for any other viruses or pathogens; and
* This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.