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FDA Issues Emergency Use Authorization for Seegene Coronavirus PCR Assay

NEW YORK – South Korean molecular diagnostics firm Seegene announced after the close of the market on Tuesday that the US Food and Drug Administration has granted Emergency Use Authorization for the firm's Allplex 2019-nCoV Assay, a real-time RT-PCR test for the SARS-CoV-2 coronavirus.

Seoul-based Seegene said in a statement that the test, which is CE-marked, and was previously authorized by Canadian regulators, and received emergency use approval in South Korea for use against the coronavirus, can identify three different target genes – the E, RdRP, and N genes – in one reaction tube, allowing for highly accurate results and maximizing the throughput for high-volume testing.

The firm added that it has sold more than 10 million of the Allplex 2019-nCoV Assay in more than 60 countries.

"Our automated system, with its advanced analysis software, has proven to be extremely useful due to its convenience and scalability, especially in such a pandemic situation where thousands of tests may be required to be performed in a day at every location," Seegene CEO Jong-Yoon Chun said in the statement.