Just over a year ago, the U.S. Food and Drug Administration (FDA) granted its first Emergency Use Authorization (EUA) for a coronavirus test. On March 17, 2021, the test review process moved to a new phase when the agency cleared a COVID-19 diagnostic via its traditional premarketing pathway for the very first time, thus allowing for marketing of the test beyond the public health emergency. The first test to make the transition from EUA to de novo clearance status is BioFire Diagnostics’ BioFire FilmArray Respiratory Panel (RP) 2.1, which detects 22 different viruses and bacteria associated with SARS-CoV-2 and other respiratory tract infections from a singly nasopharyngeal swab in 45 minutes. The FilmArray RP2.1, which was originally granted EUA clearance on May 1, 2020 (that EUA clearance has now been officially revoked as part of the transition to de novo status) runs on the firm’s FilmArray 2.0 and higher-throughput BioFire Torch systems. BioMérieux subsidiary BioFire has developed a suite of SARS-CoV-2 diagnostic products, including, among others, a singleplex assay for the FilmArray system and the RP 2.1-EZ Panel that detects the coronavirus and 18 other pathogens in point of care and near patient CLIA-waived settings. The FDA noted that it […]