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Cuur Diagnostics Molecular Coronavirus Test Gets FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Cuur Diagnostics' SARS-CoV-2 Molecular Assay.

The RT-PCR-based assay is designed to detect the virus' N, ORF1ab, and S genes in upper respiratory specimens. It is a version of Thermo Fisher Scientific's authorized TaqPath COVID-19 Combo Kit that has been modified to run on Thermo Fisher's Applied Biosystems QuantStudio 12K Flex instrument instead of the Applied Biosystems 7500 Fast Dx instrument and to use a 384-well plate format rather than a 96-well plate format. Nucleic acid extraction is performed using the Thermo Fisher's KingFisher Flex system with the MagMax Viral/Pathogen Nucleic Acid Isolation Kit.

The test may be performed only by Las Vegas, Nevada-based Cuur, the FDA said.