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FDA Grants Emergency Use Authorization for Beijing Wantai Molecular Coronavirus Test

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by Beijing Wantai Biological Pharmacy.

According to the Beijing-based company, the test is designed to detect the N and ORF1ab genes of the virus in oropharyngeal swab specimens. Nucleic acid extraction is performed using the company's Wantai Nucleic Acid Extracting Reagent or Qiagen's QIAamp Viral RNA Mini Kit, and the test runs on Bio-Rad Laboratories' CFX-96 instrument or Thermo Fisher Scientific's Applied Biosystems 7500 RT-PCR System.

The test may be used by any lab certified to perform high-complexity tests, the FDA said.

Beijing Wantai has previously received EUA from the FDA for a SARS-CoV-2 total antibody test and a rapid, lateral flow SARS-CoV-2 assay.

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