The FDA announced that it granted marketing authorization to Biomérieux subsidiary BioFire Diagnostics for its SARS-CoV-2 (COVID-19) test. Although the test already had emergency use authorization (EUA), the new marketing authorization was granted through the de novo premarket review pathway, marking the first SARS-CoV-2 diagnostic permitted to be marketed beyond the public health emergency, according […]
BioFire
DoD paying Biomérieux subsidiary $3.1M to boost COVID-19 test production
The U.S. government announced that it signed a $3.1 million agreement with Biomérieux subsidiary BioFire to expand production of its COVID-19 test. Government funding came from the U.S. Defense Dept. (DoD), in coordination with the Dept. of Health and Human Services (HHS), according to a news release. BioFire’s COVID-19 test received FDA emergency use authorization […]