MFDS "Approval of COVID-19 and Influenza Simultaneous Diagnostic Reagent... Results Available Within 3-6 Hours"

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] The Ministry of Food and Drug Safety (Minister Kim Gang-lip) announced on the 3rd that it has officially approved one reagent product that simultaneously diagnoses COVID-19 and influenza (flu). With this, the total number of COVID-19 genetic diagnostic reagents approved by the Ministry of Food and Drug Safety has reached five.

The newly approved simultaneous diagnostic reagent is manufactured by CoGen Biotech and can diagnose COVID-19 and flu simultaneously, which have similar symptoms such as cough, sore throat, and fever, making it difficult to distinguish between them.

When testing specimens from suspected patients with this product, diagnostic results can be obtained simultaneously within 3 to 6 hours with a single test, shortening the testing time and enabling appropriate treatment in a timely manner.

Currently, a total of 30 diagnostic reagent products are under review by the Ministry of Food and Drug Safety, including 14 genetic diagnostic reagents, 5 antigen diagnostic reagents, and 11 antibody diagnostic reagents, which have been formally submitted for approval.

So far, 197 COVID-19 diagnostic reagent products (100 genetic, 27 antigen, and 70 antibody) have been approved for export. As of the 27th of last month, a total of 347.23 million doses have been exported to over 160 countries worldwide, including India, the United States, Brazil, Italy, Indonesia, and the Netherlands.

The export amount reached approximately 1.3956 trillion KRW (1.22 billion USD) by September, representing newly created export volume amid the COVID-19 situation this year. Compared to last year's total export amount of in vitro diagnostic reagents (485.5 billion KRW), this is a 187% increase. It is expected to exceed 200% by the end of the year.

The Ministry of Food and Drug Safety stated, "The pioneering of new export markets is evaluated as being driven by the excellence of domestic products, combined with the internationally recognized achievements of K-quarantine." They added, "We will do our utmost to actively support the rapid development and approval of high-quality products such as COVID-19 diagnostic reagents so that the public can be guaranteed diagnostic and treatment opportunities and to support the vigorous Korean economy."

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