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

Celltrion Pharm

26/10/2020 02:16

SEOUL, Oct 26 (Reuters) - South Korea's Celltrion Inc
 068270.KS  said on Monday it has received emergency use
authorisation (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%.
    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.
    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)
 ((joori.roh@thomsonreuters.com; +82 2 6936 1493;))