BioFire Defense has received Emergency Use Authorization by the US FDA for its Biofire COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2, according to a company announcement.
The Biofire COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media. This test runs on the fully automated FilmArray 2.0 and FilmArray Torch platforms and requires only minimal training and skills in molecular biology, according to the company.
“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 U.S. Department of Defense,” said 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 in Salt Lake City, Utah. The initial test kits are committed to the DoD 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 expects to have maximum production capability within a few weeks.
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.
Note: The Biofire COVID-19 test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.