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FDA Grants Emergency Use Authorizations for Ultimate Dx, AIT Labs, MicroGenDx Coronavirus Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations (EUAs) for RT-PCR-based SARS-CoV-2 assays developed by Ultimate Dx, AIT Laboratories, and MicroGenDx.

Ultimate Dx's UDX SARS-CoV-2 Molecular Assay is designed to detect SARS-CoV-2 ORF1ab RNA in upper respiratory specimens such as nasal swabs, nasopharyngeal swabs, and oropharyngeal swabs. It is performed using Thermo Fisher Scientific's KingFisher Flex Purification System for RNA extraction and Thermo Fisher's Applied Biosystems QuantStudio 12K platform System for reverse transcription, PCR amplification, and detection.

AIT's SARS-CoV-2 Test is designed to detect the Orf1ab, N, and S regions of the virus' single-stranded RNA genome in upper respiratory specimens, including nasal and midturbinate swabs, and lower respiratory specimens such as sputum and bronchoalveolar lavage. It uses Thermo Fisher's TaqPath COVID-19 Combo Kit, which received EUA in March. RNA extraction is performed using Omega Bio-tek's MagBind Universal Pathogen Kit on Hamilton's Nimbus liquid handling system and the test runs on the QuantStudio 12K Flex real-time PCR system.

MicroGenDx's COVID-19 Key assay is designed to detect multiple sequences of the SARS-CoV-2 N gene in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, nasopharyngeal awash/aspirate or nasal aspirates, and sputum specimens. It is used with Zymo Research's Zymo Viral RNA Mag Bead Kit on the King Fisher Flex II extraction platform and Roche's Lightcycler 480II with Lightcycler 480 software version 1.5.1 sp3.

All three tests are only to be performed by the labs where they were developed, the FDA said.