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Exact Sciences, Express Gene, Avera Institute Get FDA EUAs for Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Friday granted separate Emergency Use Authorizations (EUAs) for RT-PCR-based SARS-CoV-2 tests developed by Exact Sciences, Express Gene Molecular Diagnostics Laboratory, and the Avera Institute for Human Genetics.

Exact Sciences' SARS-CoV-2 (N gene detection) Test uses primer and probe sets designed by the US Centers for Disease Control and Prevention to detect two regions in the virus' nucleocapsid gene from upper respiratory specimens such as nasal swabs. The high-throughput test runs on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx RT-PCR instrument and has a capacity of 40,000 tests per week, according to the FDA.

The Express Gene 2019-nCoV RT-PCR Diagnostic Panel is designed to detect three specific regions of the SARS-CoV-2 genome, including the ORF1ab region, and the nucleocapsid and spike protein genes, from respiratory tract specimens such as nasopharyngeal swabs and bronchoalveolar lavage. It is used with Thermo Fisher's KingFisher Flex automated DNA extraction instrument with software version 1.01 and QuantStudio 12K Flex with design and analysis software 2.2.3.

Avera's SARS-CoV-2 assay is designed to detect two regions of the virus' nucleocapsid gene from upper respiratory specimens and bronchoalveolar lavage. It runs on the Applied Biosystems Quant Studio 7 Flex with Quant Studio software v1.1 or the Applied Biosystems ViiA 7 instrument with the Quant Studio software v1.1.

All three tests are only authorized for use at their developers' CLIA-certified labs.

In April, Exact received EUA for an RT-PCR-based SARS-CoV-2 assay that detects the virus' envelope and nucleocapsid genes.