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NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by Bioeksen R&D Technologies.

The Bio-Speedy Direct RT-qPCR SARS-CoV-2 is designed for the detection of the virus' ORF1ab gene in nasopharyngeal, oropharyngeal, combined nasopharyngeal/oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasal or nasopharyngeal aspirates, nasal washes, and bronchoalveolar lavage specimens.

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