FDA gives Emergency Use Authorisation for Allplex 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2.- Seegene

Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its Allplex 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2, the novel coronavirus responsible for the COVID-19 disease. Seegene anticipates that the FDA EUA approval will now enable laboratories in the United States to run the Seegene’s test immediately for high-volume testing.

Allplex 2019-nCoV Assay is multiplex Real-time PCR assay for simultaneous detection of 3 target genes of SARS-CoV-2 in a single tube. The assay is designed to detect RdRP and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2. Results within 1 hour and 50 minutes after extraction. Detection and identification of target genes (E gene, RdRP gene, N gene) specific for COVID-19 in a single tube.