Diagnostic solution provider GenBody said Thursday that it has won the emergency use authorization (EUA) for its Covid-19 antigen rapid test kit, GenBody COVID-19 Ag, from the U.S. Food and Drug Administration.

GenBody was selected by the U.S. National Institute of Health (NIH) as the developer of its Rapid Acceleration of Diagnostics (RADx) program in March. NIH provided funding for each stage of the project totaling $10 million, and the EAU is one of its interim results, GenBody said.

RADx is a research and development project of NIH to speed up authorization, production, and supply of test kits amid the spread of Covid-19.

GenBody plans to complete the construction of its manufacturing plant in California by September. In addition, the company is installing an automated production facility and securing Good Manufacturing Practices (GMP) certificate at the plant.

With samples collected from the nasal cavity and throat with a swab, GenBody COVID-19 Ag provides test results within 15 minutes. The rapid test kit was also assessed in Korea and by Emory University in the U.S., which checked its capabilities to detect coronavirus variants like Alpha, Beta, Delta, and Gamma.

“We are glad to contribute to overcoming the Covid-19 pandemic with our rapid test kit,” said Chong Chom-kyu, chief technology officer of GenBody, “To improve the competitiveness of GenBody COVID-19 Ag, we will gather data on the accuracy of the test kit through ongoing clinical trials. Also, we will do our best to ensure its stable supply.”

Besides, GenBody attained approval from the Ministry of Food and Drug Safety for HelicoSign Dry in June. HelicoSign Dry is a dry diagnostic agent that tests infection of helicobacter pylori.

GenBody produces test kits and equipment for humans and animals and exports its products to about 50 countries, including Brazil, China, and Indonesia. It was the first company to develop the rapid test kit for the Zika virus in 2016.