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Korean virus test kit maker earns FDA emergency approval

All News 09:51 April 22, 2020

SEOUL, April 22 (Yonhap) -- Seegene Inc., a major diagnostic assay maker in South Korea, said Wednesday that it has won an emergency approval from the U.S. health authority for its test kit for the new coronavirus that has infected more than 2.5 million around the globe.

The U.S. Food and Drug Administration granted the emergency use authorization to the Allplex novel coronavirus test kit, the company said.

So far, at least 823,000 COVID-19 infections have been reported from the world's top economy, making the U.S. the biggest victim of the pandemic.

The product is also being used in South Korea under an emergency approval from the Ministry of Food and Drug Safety.

This photo provided by Seegene Inc. on April 21, 2020, shows the company's novel coronavirus test kit. (PHOTO NOT FOR SALE) (Yonhap)

Seegene has been shipping the test kits to more than 60 countries, including some of the most hard-hit countries such as Italy.

The company had already been shipping the test kits to the U.S. before the FDA's nod under cooperation with state governments.

"Using its exclusive AI-based assay design platform, Seegene was able to rapidly develop the assay shortly after the COVID-19 outbreak started in China," the company said in a statement.

"Seegene's proprietary high multiplex chemistry technology combined with its unique automated solution has played a pivotal role in South Korea's rapid response to the COVID-19 outbreak," it added.

South Korea reported another single-digit increase in new virus cases Tuesday in a clear sign of a slowdown in the spread of the new coronavirus, bringing the nation's total infections to 10,683.


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