Osang wins emergency U.S. approval for Covid-19 test kitsOsang Healthcare’s coronavirus test kits have won an emergency use authorization from regulators in the United States - a first for a Korean company.
The U.S. Food and Drug Administration (FDA) added Osang’s GeneFinder Covid-19 Plus RealAmp Kit to the list of authorized test kit manufacturers to its website on Saturday. The product detects nucleic acid for the coronavirus that causes Covid-19 by using mouth and nose swabs. It can be only be used in authorized testing labs, according to the FDA’s rules.
During emergency situations that threaten public health, the regulatory agency can allow the use of unapproved medical products to treat specific diseases or conditions. The U.S. government declared a health emergency on Feb. 4.
Four other Korean companies, Seegene, SolGent, LabGenomics and Kogene Biotech, also applied for FDA authorization to use their test kits.
Some Korean companies, however, have already received approval to legally export their test kits to the United States without having yet received the emergency authorization.
Last week, CNN reported that three Korean manufacturers, including Osang, had signed a contract with the U.S. Department of Homeland Security to provide about 750,000 coronavirus test kits,
BY SONG KYOUNG-SON [email@example.com]