bioMérieux, announced that its subsidiary, BioFire Defense, has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration for the BIOFIRE COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2.
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 is extremely easy to use, therefore requiring minimal training and skills in molecular biology.
BIOFIRE COVID-19 was developed with funding from the U.S. Department of Defense (DoD)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.
bioMérieux is currently making every effort to scale up supply of the BIOFIRE COVID-19 test at multiple production facilities in Salt Lake City, UT. 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 to address the needs of the thousands of labs and healthcare professionals using one of the nearly 11 000 BIOFIRE systems worldwide.
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.
