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.
The BioFire COVID-19 test was developed by leveraging an existing contract between BioFire Defense and the US Department of Defense. It is the second of three tests to be launched by BioMérieux for COVID-19 detection, and the firm said it will also pursue EUA for the two others.
It has already launched a test in France, called SARS-CoV-2 R-Gene, for open real-time PCR platforms, and it is working to expand its FilmArray Respiratory Panel 2 test to include SARS-CoV-2 detection. The new panel will be called FilmArray RP2.1 and will also detect 21 other pathogens that cause respiratory infections.
In addition to the COVID-19 test and respiratory panel, the FilmArray system runs a broad menu of other syndromic multiplex-PCR tests for infectious disease, including pneumonia, bloodstream infections, gastrointestinal infections, meningitis, and encephalitis. BioMérieux said in a recent earnings report that it has placed 10,400 FilmArray instruments to date.