South Korean test kit makers win US FDA pre-approval
Seoul, March 28
Three Korean coronavirus test-kit makers have won preliminary approval from the US Food and Drug Administration (FDA), paving the way for kits to be exported to the United States to help it battle the largest outbreak of the virus. South Korea’s foreign ministry said winning the preliminary approval under emergency use authorisation will allow the products to be sold in the United States. The ministry did not name the manufacturers or give a time frame in its statement. US President Donald Trump had asked his Korean counterpart earlier this week to supply the medical devices and promised to help Korean firms gain US regulator approval. A massive testing campaign, coupled with intensive contact tracing, is credited with helping South Korea slow the spread of the disease, whereas the United States has been criticised for a slow response to the virus. The approval is expected to speed up the ability to test patients in the United States, where critics say the rolling out of tests has been too slow. Swiss firm Roche has also won Emergency Use Authorisation from the FDA for its test kits. — Reuters
