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NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization to Gnomegen's COVID-19 RT-Digital PCR Detection kit for diagnosing SARS-CoV-2 infection.

According to the FDA, the in vitro diagnostic is designed for the qualitative detection of the nucleocapsid gene of the SARSCoV-2 virus in nasal, nasopharyngeal, and oropharyngeal swab specimens collected by healthcare providers. It runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 3D Digital PCR system.

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