Osang Healthcare announced that it received approval from the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for its COVID-19 RT-PCR detection kit. With the EUA, the kit would become the first FDA-approved Korean COVID-19 kit to be utilized across the U.S.
Last Saturday, the FDA issued an EUA for Osang Healthcare’s GeneFinder COVID-19 Plus Real Amp Kit. The approval notice came after a reply to the agency to correct a labeling phrase. The administration posted the approval for the kit on its website.
Osang’s GeneFinder is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in the upper and lower respiratory specimens. The virus’s nucleic acid is generally detectable during the acute phase of infection.
The COVID-19 kit detects coronavirus infection using real-time reverse transcription-polymerase chain reaction (RT-PCR), a molecular diagnostic method. The diagnostic kit determines three types of genes, the RdRp gene, the E gene, and the N gene.
The FDA’s approval came 45 days after Osang Healthcare applied for an EUA early next month. The South Korean company’s product is the 41st COVID-29 diagnostic kit to be approved by the FDA for emergency use. Osang is also the first among domestic detection kit manufacturers to apply for the U.S. agency’s EUA last March.
The Korean Ministry of Food and Drug Safety approved Osang’s GeneFinder COVID-19 Plus RealAmp in mid-March. Osang Healthcare also received European certification (CE-IVD) for its product last February.
The company said it now sells its product in over 100 countries worldwide.
Before acquiring the FDA’s approval, Osang Healthcare said it recently agreed with the U.S. Federal Emergency Management Agency (FEMA) as a supplier of testing kits worth $3 million (3.66 billion won). The agreement would ramp up the federal government’s strategic stockpile.
The FEMA deal became possible due to the FDA allowing testing laboratories with a Clinical Laboratory Improvement Amendments (CLIA) certification to import COVID-19 detection kits even if the products were in the FDA’s review stage.
Osang added that the agreement with FEMA would bump up the capacity to meet increased demand from Latin America, the Middle East, and Europe after the clearance from the FDA.
South Korea’s Ministry of Foreign Affairs (MOFA) said that three local companies, which include Osang Healthcare, received FDA’s EUA for their detection kits late March. However, the other two companies have yet to obtain results.
Osang Healthcare, founded in 1996, specializes in the development of diagnostic devices, such as glycated hemoglobin and cholesterol measuring devices, immune/molecular diagnostics devices, and blood sugar checkers. The company exports its products to over 110 countries.