FDA grants emergency authorization for Seegene COVID-19 test

By LabPulse.com staff writers

April 22, 2020 -- South Korean firm Seegene has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Allplex 2019-nCOV assay.

Seegene already has sold more than 10 million of its real-time reverse transcription polymerase chain reaction (RT-PCR) test for SARS-CoV-2 in more than 60 countries around the world. Allplex is designed to identify three different target genes (E, RdRP, and N genes) in a single reaction tube, which allows for enhanced accurate results and throughput for high volume testing.

With the FDA's EUA designation, Seegene expects U.S. laboratories to adopt the test for SARS-CoV-2.

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Last Updated ls 4/22/2020 2:08:17 PM