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FDA Grants EUAs for MiraDx, Mammoth Biosciences, BayCare Laboratories Molecular Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Monday issued separate Emergency Use Authorizations for SARS-CoV-2 tests developed by MiraDx, Mammoth Biosciences, and BayCare Laboratories.

The MiraDx SARS-CoV-2 RT-PCR assay is designed to detect the N gene of the virus in upper respiratory specimens such as nasal swab specimens or nasal aspirates. It uses Hamilton's Microlab STAR automated liquid handling system for nucleic acid extraction and runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 6 Flex PCR instrument.

The test may be performed only by Los Angeles-based MiraDx.

Mammoth's SARS-CoV-2 DETECTR Reagent Kit is a CRISPR-based reverse transcription and loop-mediated amplification (RT-LAMP) test designed for the detection of the virus' N gene in upper respiratory specimens. Nucleic acid extraction is performed with Qiagen's EZ1 Virus Mini Kit v2.0 and the test runs on the Applied Biosystems 7500 Fast Dx RT-PCR instrument using the Applied Biosystems MicroAmp Fast Optical 96-Well Reaction Plate, according to South San Francisco-based Mammoth.

The test may be used by any lab CLIA-certified to perform high-complexity tests.

The BayCare SARS-CoV-2 RT PCR Assay uses Roche's authorized Cobas SARS-CoV-2 Test, which detects the virus' ORF1ab and E genes. BayCare's test is designed for use with single nasopharyngeal swab specimens or pooled samples containing up to two individual specimens, and it runs on Roche's Cobas 6800 or 8800 RT-PCR systems.

The test may be performed only by Tampa, Florida-based BayCare.