More POC COVID-19 Tests Approved: BioFire, Mesa

The FDA approved BioFire FilmArray COVID-19 test, as well as Mesa Biotech’s Accula.  Both can bring a COVID-19 diagnosis to the point of care where testing is most needed.   BioFire’s Film Array has thousands of placements.  Accula is a hand-held test.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

Tests approved with an EUA include:

• Mesa Biotech Inc. Accula SARS-Cov-2 Test
• BioFire Defense, LLC BioFire COVID-19 Test
• Cepheid Xpert Xpress SARS-CoV-2 test
• GenMark ePlex SARS-CoV-2 Test
• DiaSorin Molecular LLC Simplexa COVID-19 Direct assay
• Abbott Molecular Abbott RealTime SARS-CoV-2 assay
• Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR
• Quidel Corporation Lyra SARS-CoV-2 Assay
• Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test
• Primerdesign Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
• Hologic, Inc. Panther Fusion SARS-CoV-2
• Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit
• Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2