Marcy l’Etoile (France) - October 27, 2014 - BioFire Defense, LLC of Salt Lake City, UT announced today that it has received Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for its commercial FilmArray® Ebola test (BioThreat-E testTM).
The test runs on the BioFire FilmArray® system, a highly accurate, fast, and easy-to-use PCR* molecular diagnostic instrument which is currently used in hundreds of hospitals in the United States. The system delivers test results in one-hour, significantly reducing current testing time and allowing health professionals to make treatment decisions faster.
“This EUA and FilmArray® test for Ebola are the result of a long collaboration and close working relationship with U.S. Department of Defense. The FDA has been an excellent working partner providing the feedback needed to ensure the efficacy of such an important diagnostic test,” said Kirk Ririe, CEO of BioFire Defense. “It is our mission to help improve public health and the rapid turnaround and ease-of-use of FilmArray® will certainly be a great help for the healthcare professionals in the context of the Ebola outbreak.”
The commercial BioThreat-E testTM is now available to high and moderate complexity clinical laboratories in the U.S. It 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**, unless the authorization is terminated or revoked sooner.
The Ebola virus epidemic is a global health emergency, and the Group is prepared to work with local authorities to ensure this test is available in all countries that would need to use it for clinical testing.
* PCR: Polymerase Chain Reaction
** Under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1)