BioFire® COVID-19 Test – Now Authorized by FDA under Emergency Use Authorization (EUA)
In collaboration with the Department of Defense, BioFire Defense has developed a fully-automated, sample-to-result assay for the specific detection of SARS-CoV-2, the causative agent of COVID-19. This assay is designed to run on both the BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems, delivering results in about 45 minutes. After meeting initial DoD demand, commercial availability under EUA is anticipated in April of 2020. Inquiries should be directed to your BioFire Diagnostics Sales Representative.
BioFire® Respiratory 2.1 Panel
In parallel, BioFire Diagnostics is developing new SARS-CoV-2-specific assays for addition to the BioFire® FilmArray® Respiratory 2 (RP2) Panel. This new panel will be named the BioFire® Respiratory 2.1 (RP2.1) Panel and is being developed for both the BioFire 2.0 and BioFire Torch Systems. In addition to the detection of SARS-CoV-2, the BioFire RP2.1 Panel will detect 21 additional respiratory pathogens to help clinicians quickly rule in and rule out other common causes of respiratory illness in about 45 minutes. Development of the BioFire RP2.1 Panel is also occurring on an accelerated timeline, and submission to the FDA for EUA and 510(k) clearance is anticipated in Q3 of 2020.
For more information, please contact the BioFire Customer Technical Support team at 1-801-736-6354, Option 5, or by email at firstname.lastname@example.org.
Click the icons below for more information on the respiratory solutions currently offered by BioFire Diagnostics to help clinicians quickly identify common respiratory pathogens.