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Biocore wins FDA nod for coronavirus test kit

According to Yonhap News,

SEOUL, May 22 (Yonhap) -- South Korean molecular diagnostics firm Biocore Co. said Friday it has received approval from the U.S. Food and Drug Administration (FDA) for emergency use of its coronavirus test kit.

Biocore said it has become the seventh South Korean COVID-19 test kit manufacturer that has garnered emergency use authorization (EUA) from the U.S. agency.

Other South Korean companies that received EUA status include Osang Healthcare, Seegene, SD Biosensor, Seasun Biomaterials, LabGenomics and GeneMatrix.

Biocore had earlier obtained approval for emergency use and exports of its test kit from South Korea's Ministry of Food and Drug Safety. Only two other domestic firms -- Seegene and SD Biosensor -- have won approval for both purposes from the ministry.

Biocore said the FDA approval will likely help boost its test kit exports. The company currently exports test kits to about 20 countries, including Germany, Italy and Spain.

The ministry, meanwhile, said South Korean firms had exported COVID-19 test kits capable of conducting 56 million tests to 110 countries as of Wednesday. So far, 73 locally made test kits have been approved for exports.

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Source: Yonhap News (May 22, 2020)

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