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Celltrion's coronavirus self-test kit gets FDA emergency approval

National 10:33 October 25, 2021

By Kim Han-joo

SEOUL, Oct. 25 (Yonhap) -- 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.

This imaged, provided by South Korean biopharmaceutical company Celltrion Inc. on Oct. 25, 2021, shows its DiaTrust COVID-19 Ag Home Test. (PHOTO NOT FOR SALE) (Yonhap)

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.

khj@yna.co.kr
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