iCure "Domestic Distribution of Zenbody's COVID-19 Self-Test Kit"

[Asia Economy Reporter Yoo Hyun-seok] iCure announced on the 20th that it is responsible for the domestic distribution of GenBody's COVID-19 rapid antigen test kits.

As of the 15th, the rapid antigen test kits officially approved by the Ministry of Food and Drug Safety (MFDS) in Korea are from four companies: GenBody, Repigen, SD Biosensor, and Humasis. According to the company, these products are being used as auxiliary tools by doctors to diagnose COVID-19 infection at temporary screening clinics in the metropolitan area.

A company representative stated, "GenBody has been recognized for the excellence of its rapid antigen test kits and received $10 million (approximately 11 billion KRW) in funding from the U.S. National Institutes of Health (NIH). It is currently expanding production facilities and pursuing FDA Emergency Use Authorization (EUA) approval in the United States." He added, "After completing sufficient clinical trials in the U.S., GenBody applied for FDA EUA approval last month and verified the quality of its monoclonal antibodies as raw materials with support from the U.S. NIH." He further noted, "iCure is in charge of distributing GenBody's products to the government, local governments, and public institutions."

Meanwhile, GenBody's COVID-19 rapid antigen test kit received the second domestic approval from the MFDS for local use in December last year and is currently on the market. It is now exported and sold in approximately 57 countries.