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BGI Genomics Gets CE Mark for Multiplexed SARS-CoV-2, Influenza Tests

NEW YORK – BGI Genomics said on Thursday that it has received CE marking for two multiplexed tests for SARS-CoV-2 and influenza A/B produced by its subsidiary BGI PathoGenesis Pharmaceutical Technology.

Both real-time fluorescent RT-PCR tests are for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B from throat swab samples using a single reaction. One test detects the SARS-CoV-2 ORF1ab gene, while the second test detects the virus's ORF1ab and N genes.

As the clinical symptoms of influenza A and influenza B infection and COVID-19 are similar, the new multiplex tests can help rapidly triage testing populations, BGI said.

In March, BGI garnered CE marking for its Real-Time Fluorescent RT-PCR kit for SARS-CoV-2, while its BGI Americas subsidiary received US Food and Drug Administration Emergency Use Authorization for the same test.