Several Korean companies are exporting Covid-19 tests to the US with a rise in Omicron variant of the SARS-CoV-2 virus, Koreanbiomed reported. South Korean firm Humasis entered an agreement with Celltrion to distribute Covid-19 antigen self-test kits worth $43.5m to the US. Humasis jointly developed Covid-19 antigen diagnostic kits with Celltrion and produces Covid-19 testing kits of the latter. Meanwhile, another Korean company SD Biosensor received emergency use authorization from the US Food and Drug Administration for its Covid-19 self-test kit COVID-19 At-Home Test. The company also signed a strategic collaboration with Roche enabling its entry into the US market.
Quidel has reported that its QuickVue At-Home OTC COVID-19 Test and Sofia SARS Antigen FIA possess the ability to identify the Omicron variant of the SARS-CoV-2 virus. The ability was established after testing the assays using live South African samples. Last week, the Food and Drug Administration findings from initial RADx laboratory studies with heat-inactivated Omicron samples showed that the QuickVue antigen tests could detect the Omicron variant with performance in par with other viral variants.
The US Food and Drug Administration said that some rapid Covid-19 antigen tests could be less sensitive in identifying the Omicron variant of the SARS-CoV-2 virus. The FDA is set to partner with the US National Institutes of Health under the RADx programme to evaluate the ability of various antigen tests for Omicron detection. According to initial data, the antigen tests showed the ability to identify Omicron variant but with a diminished sensitivity.