BioMérieux Rapid Coronavirus Test Gets FDA Emergency Use Authorization
Mar 24, 2020 | staff reporter
NEW YORK –BioMérieux said on Tuesday that an assay developed by its subsidiary BioFire Defense to rapidly detect COVID-19, the disease caused by SARS-CoV-2 virus, was granted Emergency Use Authorization by the US Food and Drug Administration.
The BioFire COVID-19 test detects SARS-CoV-2 from nasopharyngeal swabs in transport media in approximately 45 minutes. The test can be run on the BioFire FilmArray system as well as the higher-throughput FilmArray Torch, as previously reported. These platforms require minimal skill and training to operate. They are closed and fully-automated systems that integrate sample preparation, amplification, and detection.
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, the firm said in a statement.