NEW YORK ¨CBioM¨¦rieux 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.
BioM¨¦rieux 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 BioM¨¦rieux 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. BioM¨¦rieux said in a recent earnings report that it has placed 10,400 FilmArray instruments to date.
