South Korea pharma Celltrion’s Covid test gets U.S. emergency use authorization

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South Korea pharma Celltrion’s COVID test gets U.S. emergency use authorisation

SEOUL (Reuters) – South Korea’s Celltrion Inc 068270.KS said on Monday it has received emergency use authorization (EUA) from the U.S. Food & Drug Administration (FDA) for its rapid COVID-19 testing kit Sampinute, which boosted shares of the company and its affiliates.

Celltrion said Sampinute delivers coronavirus test results within 10 minutes, with a sensitivity of around 94%.

FILE PHOTO: The logo of Celltrion is seen at company’s headquarters in Incheon, South Korea, October 28, 2016. REUTERS/Kim Hong-Ji

The authorization came three months after requesting approval in late July and the product has already been launched in the United States in August, according to the company statement.

“(The company) is planning to supply Sampinute across the United States through local wholesalers as it believes the demand for rapid diagnosis kits will be high, mainly among large businesses and government agencies that are about to return to work after telecommuting,” it said in a statement.

Shares of Celltrion Inc surged as much as 4.6%, while Celltrion Pharm 068760.KQ and Celltrion Healthcare 091990.KQ jumped 4.6% and 1.6%, respectively. Broader KOSPI .KS11, however, was trading down 0.1% as of 0208 GMT.


Reporting by Joori Roh; Editing by Kim Coghill


Reuters source: