SEOUL, Oct. 25 (Korea Bizwire) — South Korean biopharmaceutical company Celltrion Inc. said Monday that its self-diagnostic kit for the novel coronavirus has won emergency approval from U.S. drug authorities.
Celltrion DiaTrust COVID-19 Ag Home Test, co-developed by local healthcare business Humasis, received the U.S. Food and Drug Administration’s Emergency Use Authorization approval.
The product uses an antibody that specifically binds to the COVID-19 virus and detects infection within 15 minutes, Celltrion said. It is most suitable for identifying acute or early infection of the COVID-19 virus.
Celltrion USA, which handles Celltrion’s overseas business, will be responsible for the sales.
The self-test kit has also won approval for emergency use by other countries, including South Korea. It is also used in several European countries.