Bodytechmed COVID-19 Home Test Kit, FDA Emergency Use Authorization

Point-of-care diagnostics specialist Boditech Med announced on the 20th that it had obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on the 17th (local time) for its COVID-19 home test kit, 'Swab-N-Go Home Test COVID-19 Ag.'

Bodytechmed's COVID-19 home test kit 'Swab-N-Go Home Test COVID-19 Ag' [Photo by Bodytechmed]

This approval was achieved over the past year through its U.S. subsidiary Immunostics in New Jersey, and future production and sales will also be conducted through Immunostics. Additionally, Boditech Med explained that in preparation for the EUA in May, it signed a supply contract with CLIAwaived, which has a sales network not only across the United States but worldwide.

Choi Eui-yeol, CEO of Boditech Med, said, “The EUA was somewhat delayed compared to the original plan, but I am confident that this will serve as a foothold to fully enter the U.S. market amid the COVID-19 phase transitioning into an endemic.”