The FDA announced that it granted marketing authorization to 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 to an FDA release.
“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,” FDA Acting Commissioner Dr. Janet Woodcock said in the release. “We ensured there were tests made available quickly under EUA; and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities.
“While this is the first marketing authorization for a diagnostic test using a tra…