SD Biosensor’s coronavirus test kit gains US FDA’s emergency use approval

SD Biosensor said Friday it has become the third Korean COVID-19 test kit maker to gain US Food and Drug Administration’s emergency use approval.

The company’s nCoV Real-Time Detection Kit was already being exported to the US under deals with Federal Emergency Management Agency. The official EUA is anticipated to increase the export volume.

With the addition of SD Biosensor, currently three Korean companies including Osang Healthcare and Seegene now have the FDA’s EUA.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)