Solgent’s test kit receives emergency use authorization from FDA

Solgent’s COVID-19 test kit has received emergency use authorization from the US Food and Drug Administration, becoming the 10th South Korean kit to receive the green light from the agency.

According to industry sources Sunday, the DiaPlexQ kit is a real-time polymerase chain reaction test kit that can produce a diagnosis in under two hours.

Solgent was already exporting the test kits to the US, with the first batch of 150,000 test kits going out last month. Last month, the company also became the first Korean company to register with the US Federal Emergency Management Agency as a supplier of strategic materials.

Solgent currently exports the test kits to some 40 countries.

Currently, 10 test kits made by nine Korean companies have received emergency use authorization from the US FDA. The others are Seegene, Osang Healthcare, SD Biosensor, Seasun Biomaterials, LabGenomics, 1drop, GeneMatrix and Biocore. Seasun Biomaterials makes two of the approved test kits.

By Kim Byung-wook (kbw@heraldcorp.com)