COVID-19 Diagnostic Kit Taking 2 Hours Approved in US... First EUA for Korean Company

Osang Healthcare Diagnostic Kit, First Korean Company to Receive Emergency Use Authorization in the U.S.

Osang Healthcare's COVID-19 diagnostic kit 'GeneFinder™ COVID-19 Plus RealAmp Kit'

[Asia Economy Reporter Choi Dae-yeol] A diagnostic kit for COVID-19 developed by a domestic company has received Emergency Use Authorization (EUA) in the United States. The U.S. Food and Drug Administration (FDA) has primarily granted EUAs to domestic companies, making this the first time a Korean company has obtained EUA within the U.S.

On the 18th (local time), the FDA approved Osang Healthcare's COVID-19 diagnostic kit, "GeneFinder COVID-19 Plus RealAmp," and added the product to the EUA list. Earlier, local media reported that the company signed a contract with the U.S. Federal Emergency Management Agency (FEMA) to export a total of approximately 750,000 diagnostic kits along with other domestic diagnostic device manufacturers.

SD Biosensor and Solgent have also received emergency approvals domestically, while Osang Healthcare's diagnostic kit has only obtained export approval. Previously, a Korean-American company headquartered in the U.S., Abellino Lab, received approval on the 25th of last month. Since FEMA is overseeing the COVID-19 response in the U.S., it is expected that SD Biosensor and Solgent, which have already supplied products locally, will receive approval soon. According to the Ministry of Foreign Affairs, some domestic companies have signed contracts and exported products to the U.S. under "provisional approval."

The diagnostic kit from Osang Healthcare approved in the U.S. uses a molecular diagnostic method with high accuracy to determine COVID-19 infection. According to the company, it takes about two hours using the real-time RT-PCR method. The Korean quarantine authorities have also granted emergency approval for some products to diagnose COVID-19, all of which use the real-time RT-PCR method.

So far, a total of 41 products have received EUA in the U.S., most of which use molecular diagnostic methods, while four are serological tests that detect antibody formation to assess infection. As COVID-19 cases increase, U.S. authorities are easing regulations and expediting approvals across various fields, including in vitro diagnostic devices. They have allowed state-level approvals for COVID-19 diagnostic kits and, since mid-last month, permitted products that have completed performance verification and are undergoing EUA application procedures to be marketed after informing about their product characteristics. This measure was taken due to the shortage of COVID-19 diagnostic kits at the time.

This content was produced with the assistance of AI translation services.