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April 22, 2020

US FDA grants emergency use authorisation for Seegene’s Covid-19 test

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Seegene’s Allplex 2019-nCoV Assay for Covid-19.

Allplex is a real-time RT-PCR test for SARS-CoV-2, the novel coronavirus which causes the disease. It is being used as a standard SARS-CoV-2 assay and can identify E, RdRP and N target genes in a single reaction tube.

The authorisation is expected to enable US laboratories to run the Seegene’s test immediately for high-volume testing.

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