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FDA Grants Emergency Use Authorization for George Washington University Coronavirus PCR Test

NEW YORK — The US Food and Drug Administration on Friday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed at George Washington University.

The GWU COVID-19 RT-PCR test is designed to detect the SARS-CoV-2 N gene in upper respiratory specimens and bronchoalveolar lavage. Nucleic extraction is performed using Thermo Fisher Scientific's MagMax-96 Viral RNA Isolation Kit on Hamilton's Microlab STAR Liquid Handling System, and the test runs on the Roche LightCycler 480 instrument.

The test may be performed only at the George Washington University Public Health Laboratory in Washington DC, according to the FDA.