Kogene Biotech said that the U.S. Food and Drug Administration (FDA) recently invited South Korea’s COVID-19 detection kit maker to apply for emergency use authorization (EUA) under the United States government. The request came amid the increasing demand for coronavirus testing across the country.
Kogene Biotech first delivered the detection kit to the market following the South Korean government’s EUA system. Local media first introduced the company as the first domestic biotech company to create a COVID-19 detection kit.
The Korean company, now flooded with orders, exports its latest COVID-19 detection kit dubbed “PowerChek” to about 30 countries.
Nam Yong-seok, Kogene Biotech’s president, said that orders for the company’s kit come from Korean embassies, domestic distributors, and KOTRA offices across the globe. He added that upon EUA approval, the detection kit would be available across the U.S.
Nam founded Kogene Biotech in 2000. He worked at the National Institute of Infectious Diseases and Allergy (NIAID) under the U.S. Centers for Disease Control and Prevention as a postdoctoral researcher.
Kogene Biotech is also in a registration process to participate in international public procurement bidding.
The biotech firm’s PowerChek shipment recently saw an increase in Middle Eastern, African, European, and African countries.
Last month, the company obtained Europe’s CE-IVD (CE In-vitro Diagnostic Device) certification. It also secured a license for export items for the kit. With the certification and license, Kogene Biotech is in talks with Hong Kong, China, Japan, and North and South American to provide the kits.
Kogene Biotech supplies an average of 10,000 kits weekly. The company guaranteed to scale up to three times the current production rate as the need arises.
PowerChek’s key technology lies in its real-time PCR based assay with which the company developed around 800 reagents for gene testing over the past 20 years.
The detection kit can identify two genes (E and RdRp) that only detect the COVID-19 virus through the exclusion of specific genes, which can create diagnostic errors caused by genetic mutations.
Kogene Biotech optimized PowerChek for universal use in any equipment. The kit allows for verification procedures to be completed with commonly utilized diagnostics equipment.
In 2009, the company developed the first diagnostic reagents for H1N1 influenza and in 2015 for the MERS outbreak in Korea.
Nam said that last December the company began a literature review after coronavirus news in China. Kogene Biotech, then, started development on January 10 after GISAID unveiled the virus genetic information.