GenBody said Thursday that the U.S. Food and Drug Administration granted emergency use authorization (EUA) for its GenBody COVID-19 antigen (Ag), a rapid diagnostic kit for Covid-19 in a nasal sampling format on Sep. 24.

GenBody COVID-19 Ag provides diagnosis results within 15 minutes and can prevent the spread of variant cases as it can also detect variant cases, it said.

The company obtained EUA from the FDA in the form of using GenBody COVID-19 Ag through a nasopharyngeal swab in July. However, the test method caused pain and discomfort to test receivers as medical staff had to swab the sample behind the nasal area.

"We expect that the EUA will make it more convenient to test for Covid-19 as it is possible to test for Covid-19 infection with a sample from the nasal area in front of the nose," a company official said.

The official explained that the EUA resulted from the RADx (Rapid Acceleration of Diagnostics) R&D program, which has been in progress since August last year.

The U.S. National Institutes of Health (NIH) is conducting the RADx R&D program to accelerate the approval and production of Covid-19-19 diagnostic kits. GenBody has been participating in the program as a developer. The company is currently exporting GenBody COVID-19 Ag kits to the U.S. and plans to start full-scale production from November in automated facilities in California.

“With the recent spread of the Covid-19 Delta variant, the demand for rapid antigen diagnostic kits is growing," GenBody CTO Chong Chom-kyu said. " For the mass production and supply of GenBody COVID-19 Ag, the company will apply for an additional program to the NIH and do its best to overcome the crisis caused by Covid-19 in the future.”

Chong also stressed that in keeping with the shift of the quarantine system to a "live-with-covid” system as are the cases in several countries, the company is working on receiving EUA for a self-test version of its COVID-19 Ag that people can use at home or work through the U.S. NIH's RADx program.