Osang Healthcare, COVID-19 Diagnostic Kit Export Approval Granted by MFDS

[Asia Economy Reporter Oh Ju-yeon] Osang Jaeil announced that its subsidiary Osang Healthcare obtained export approval on the 18th for a molecular diagnostic kit capable of diagnosing COVID-19, which was applied for last month to the Ministry of Food and Drug Safety.

An Osang Healthcare official explained, "This export approval from the Ministry of Food and Drug Safety secures a foothold to respond to the international reliability of the COVID-19 diagnostic kit, as well as the flood of export inquiries and large orders from overseas."

The diagnostic kit developed by Osang Healthcare and approved by the Ministry uses the real-time polymerase chain reaction (RT-PCR) method, qualitatively detecting three target genes of COVID-19 (E Gene, RdRp Gene, N Gene). It allows simultaneous testing in one tube, enhancing user convenience and efficiency for large-scale testing.

Osang Healthcare has also applied for emergency use authorization from the U.S. FDA and is awaiting the results.

A company representative stated, "After obtaining European certification (CE-IVD) last month, we are negotiating prototype testing and export contracts with regions including Europe, the United States, Mexico, the Middle East and Africa, and Asia," adding, "With this export approval from the Ministry of Food and Drug Safety, we can expect large orders from several countries currently in export negotiations."

Meanwhile, Osang Healthcare is a medical device specialist company possessing diagnostic kits and reagents for various adult diseases and viral infections. Its Influenza A&B diagnostic kit holds the number one market share domestically. Currently, it exports and sells about 30 products to over 110 countries overseas, with exports accounting for 85% of total sales.