South Korea pharma Celltrion's COVID-19 test gets US emergency use authorisation

South Korea pharma Celltrion's COVID-19 test gets US emergency use authorisation

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

SEOUL: South Korea's Celltrion said on Monday (Oct 26) it has received emergency use authorisation (EUA) from the US 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 per cent.

READ: South Korea's Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug

The authorisation 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.

READ: South Korea's Celltrion to begin commercial production of COVID-19 antibody drug

Shares of Celltrion Inc surged as much as 4.6 per cent, while Celltrion Pharm and Celltrion Healthcare jumped 4.6 per cent and 1.6 per cent, respectively. 

Broader KOSPI, however, was trading down 0.1per cent as of 0208 GMT.

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Source: Reuters/ad

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