Genetron secures EUA for SARS-CoV-2 RNA test

2020 02 18 19 50 1406 Rna Strand 400

Genetron Health of Beijing has secured emergency use authorization (EUA) clearance from the U.S. Food and Drug Administration (FDA) for its SARS-CoV-2 RNA test.

The company has also received approval for export from the China Chamber of Commerce for Import and Export of Medicines and Health Products.

The assay identifies two SARS-CoV-2 gene sequences: ORF1ab and N. It takes less than three hours to process, and has already received the CE Mark for distribution in Europe, according to the firm.

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