FDA has recently granted emergency use authorization (EUA) to BioFire Defense LLC, Salt Lake City, for its commercial FilmArray test for the ebola Zaire virus (BioThreat-E test).
The test runs on the BioFire FilmArray system, a fast, highly accurate, and easy-to-use polymerase chain reaction (PCR)-based molecular diagnostic instrument that is currently used in hundreds of hospitals in the United States. The system delivers test results in 1 hour, significantly reducing current testing time and enabling health professionals to make treatment decisions faster.
“This EUA and the FilmArray test for ebola are the result of a long collaboration and close working relationship with US Department of Defense,” says Kirk Ririe, CEO of BioFire Defense. “FDA has been an excellent working partner providing the feedback needed to ensure the efficacy of such an important diagnostic test,” he adds. “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.”
BioFire Defense is a subsidiary of bioMérieux Inc, Durham, NC, and is focused on technology innovation and product development for pathogen identification and life science applications. The business unit has developed and provided products for defense, food testing, and the life sciences since 1990. BioFire Diagnostics LLC, its sister subsidiary, continues delivering and expanding clinical applications of the FilmArray system to hospital-based clinical laboratories across the world.
The commercial BioThreat-E test is now available to high- and moderate-complexity clinical laboratories in the United States. Use of the test is authorized only for the duration of the declaration (under 21 USC 360bbb-3(b)(1)) that circumstances exist to justify the emergency use of in vitro diagnostics for the detection of ebola Zaire virus, unless the authorization is terminated or revoked sooner.
The ebola virus epidemic is a global health emergency, and the BioFire group is prepared to work with local authorities to ensure that its test is available in all countries that would need to use it for clinical testing. For additional information, visit bioMérieux.