BioFire Defense, Salt Lake City, a subsidiary of bioMérieux, Marcy-l’Etoile, France, has received FDA emergency use authorization (EUA) for its BioFire Covid-19 test for use in CLIA moderate- and high-complexity clinical laboratories to detect SARS-CoV-2.
The BioFire Covid-19 test test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media. The test runs on the fully automated FilmArray 2.0 and FilmArray Torch platforms and is extremely easy to use, therefore requiring minimal training and skills in molecular biology. BioFire Covid-19 was developed with funding from the US Department of Defense by leveraging an existing contract agreement with BioFire Defense. This is the second of three tests being developed for diagnostic use as part of bioMérieux’s strategic response to the covid-19 pandemic.
“The rapid development of this test is a combined result of the extensive effort and dedication of our employees, the assistance of our partner Midwest Research Institute Global, and the confidence entrusted to us by the US Department of Defense,” says Bob Lollini, CEO of BioFire Defense.
BioMérieux is currently making every effort to scale up supply of the BioFire Covid-19 test at multiple production facilities. The initial test kits are committed to the Department of Defense for redistribution. Test kits will be available for commercial distribution in the United States under the EUA as well as internationally where regulatory approval allows.
BioMérieux has also received authorization to sell the BioFire Covid-19 test external control kit. This positive control material may be used for quality control and laboratory verification of the test.