U.S. FDA grants approval to BioFire’s COVID-19 diagnostic test

Following an emergency use authorization offered last year, the U.S. FDA has now granted marketing authorization to BioFire Respiratory Panel 2.1, a diagnostic test designed to detect and identify multiple bacterial and viral infections among individuals that are suspected of COVID-19 and other respiratory ailments.

Confirming the approval, Dr. Janet Woodcock, Acting Commissioner of FDA, said that the BioFire authorization will anchor further approval of critical COVID-19 diagnostic tests. The recent authorization exhibits FDA's efforts on protecting public health in emergency response situations and beyond.

The agency previously ensured that tests were made available more quickly under EUA (Emergency Use Authorization) and it will remain persistent in working with diagnostic manufacturers to help ensure that products are FDA examined for effectiveness and safety and are authorized for marketing under the agency’s traditional premarket authorities.

Subsequently after attaining approval for the tests in May 2020, BioFire said the panel will enable health care providers to promptly detect patients with respiratory pathogens as well as COVID-19. The BioFire panel takes around 45 minutes and can test samples collated using nasal swab.

The BioFire test was approved via an FDA process that is specifically tailored for new and groundbreaking medical devices and products and is the first U.S.-developed COVID-19 test procedure to obtain full approval.

In an official statement, Lauren-Jei McCarthy, FDA press officer, said that the BioFire Respiratory Panel 2.1. was provided marketing authorization using the De Novo premarket review pathway. This is a regulatory procedure for new type of low- to moderate-risk devices. The approval of the De Novo request is crucial as it is the first COVID-19 diagnostic test permitted to be marketed beyond emergency use.

Acquired by French biotech giant bioMérieux in 2014, BioFire has built enough success in U.S. markets. In 2017, bioMérieux invested $100 million in a new Research Park facility called the Alain Mérieux Center for Molecular Diagnostics for BioFire.

Source Credit: https://www.ksl.com/article/50130007/utah-biotech-firm-biofire-earns-first-full-fda-covid-19-test-approval