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NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for SARS-CoV-2 tests from Applied BioCode, Kaiser Permanente, and Emory University.

Applied BioCode's SARS-CoV-2 Assay is designed to detect two conserved regions in the virus' N gene in upper respiratory specimens and bronchoalveolar lavage. Nucleic acids are extracted using BioMérieux's NucliSens EasyMag or Roche's MagNA Pure 96 automated systems and the test runs on Applied Biocode's MDx-3000 instrument. The assay may be performed by any lab CLIA-certified for high-complexity tests.

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