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

22 April 2020 (Last Updated April 22nd, 2020 13:19)

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.