South Korea pharma Celltrion’s COVID test gets US emergency use authorisation

South Korea’s Celltrion said on Monday it has received emergency use authorisation (EUA) from the US Food & Drug Administration (FDA) for its rapid COVID-19 testing kit Sampinute.

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

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.