FLC | DoD-funded French COVID-19 test wins FDA Emergency Use Authorization

DoD-funded French COVID-19 test wins FDA Emergency Use Authorization

March 29, 2020

French diagnostics firm bioMerieux said Tuesday that its subsidiary, BioFire Defense, had secured emergency approval from US regulators for a coronavirus test that can produce results in 45 minutes, potentially offering a new tool for stemming the outbreak.

BIOFIRE® COVID-19 was developed with funding from the U.S. Department of Defense (DoD) by leveraging an existing contract agreement with BioFire Defense. 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 at its sites in Salt Lake City, Utah, 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.

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.

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.

bioMerieux said its coronavirus test is the first of three under development for the virus, whose technical name is SARS-CoV-2. They include a real-time DNA test for coronavirus that has already been approved by French regulators, which could soon be approved by European and US regulators as well.