Osang Healthcare said it has won the U.S. Food and Drug Administration’s approval for emergency use of the test kit for the new coronavirus, which was the first for a Korean firm.
The FDA said on Saturday it issued an emergency use authorization (EUA) for Osang’s product, GeneFinder COVID-19 Plus RealAmp Kit.
|A lab worker uses Osang Healthcare’s Covid-19 test kit.|
GeneFinder uses a molecular diagnostic method to check Covid-19 infection using real-time reverse transcription-polymerase chain reaction (RT-PCR). The test kit detects three types of target genes – E gene, RdRP gene, and N Gene.
The FDA’s grant came about 45 days after Osang Healthcare applied for an emergency use approval in early May. Osang’s product is the 41st Covid-19 diagnostic kit approved by the FDA for emergency use, and also the first among Korean test kits.
Some other local companies are also expected to receive the green light for emergency use soon, but Osang is the only company ever mentioned on the FDA’s website so far.
Osang said it would actively seek to export GeneFinder around the world. The company received European certification (CE-IVD) on the product in February and local regulatory approval for export in March. Since then, it has been selling large quantities of GeneFinder testing kits to Italy, Romania, Morocco, Brazil, and Russia.
Before the FDA granted the nod for emergency use, the company had agreed with the U.S. Federal Emergency Management Agency (FEMA) on the supply of the testing kits worth $3 million. This was possible because the FDA allowed testing laboratories that have the Clinical Laboratory Improvement Amendments (CLIA) certification to import detection kits even if the products were in the FDA’s review stage.
Founded in 1996, Osang Healthcare specializes in diagnostic device development. The company exports various diagnostic devices, including immune/molecular diagnostics, blood sugar checkers, glycated hemoglobin and cholesterol measuring devices to over 110 countries.
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