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The test is the first COVID-19 assay to transition from Emergency Use Authorization to a cleared regulatory status.
Some tests that detect multiple SARS-CoV-2 genes are serendipitously signaling new viral variants while still effectively detecting infections.
The BioFire Defense subsidiary of BioMérieux obtained clearance for its FilmArray Global Fever Panel External Control Kit, used with the FilmArray Global Fever Panel.
The test, developed by BioMérieux subsidiary BioFire Defense, first received Emergency Use Authorization from the US Food and Drug Administration in March.
BioFire has submitted a 39-target test to the US Food and Drug Administration. OpGen also has a test in development.
The firm saw 120 percent growth in the BioFire FilmArray product line driven by strong demand for a respiratory panel which can detect SARS-CoV-2.
BioFire's test is designed to detect and differentiate between SARS-CoV-2 and other respiratory pathogens, while UMass Medical's test is only for SARS-CoV-2.
The firm expects organic revenue growth of approximately 11 percent at constant exchange rates compared to the second quarter last year.
A handful of recently published trials suggest that use of the pneumonia panel could lead to more targeted therapy delivered more quickly than standard methods.
The panel is designed to detect and differentiate between nucleic acids from SARS-CoV-2 and 20 other viral and bacterial respiratory pathogens.