South Korea’s Seegene says US FDA gave emergency nod for its fast Coronavirus PCR test
ECONOMYNEXT – South Korea-based Allplex said its rt-PCR test for Coronavirus has been given Emergency Use Authorization by the US Food and Drug Administration.
Seegene says its SARS-CoV-2 assay, identifies 3 different target genes (E, RdRP and N genes) in a single reaction tube, which improves accuracy and allows high volume testing.
“Our automated system, with its advanced analysis software, has proven to be extremely useful due to its convenience and scalability, especially …where thousands of tests may be required to be performed in a day at every location,” Jong-Yoon Chun, CEO of Seegene said in a statement.
Seegene says the FDA EUA approval will allow labs in the United States to run the Seegene’s test for high-volume testing.
Another South Korean company, Lab Genome, is also producing tests.
The US state of Maryland had imported some of their test kits, reports said.