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Celltrion's coronavirus test kit gets CE mark in Europe

All News 08:46 July 17, 2020

By Kim Han-joo

SEOUL, July 17 (Yonahp) -- South Korean biopharmaceutical company Celltrion Inc. said Friday its diagnostic kit for the novel coronavirus has won approval from European authorities.

A point-of-care antigen testing (POCT) kit for the COVID-19 virus, co-developed by a local health care business, recently obtained a CE marking from the European Union (EU), company officials said.

This photo, provided by Celltrion Inc. on June 16, 2020, shows the company's corporate logo. (PHOTO NOT FOR SALE) (Yonhap)

Obtaining a CE marking indicates that a medical device complies with the applicable EU regulations and enables the commercialization of products in 32 European countries.

The POCT kit is a portable and highly sensitive device that reduces the test time to between 15 and 20 minutes, according to Celltrion. The test time is considered the quickest among kits available on the market.

Celltrion Healthcare, which handles Celltrion's overseas business, will be responsible for overseas sales, except for the United States.

Celltrion said its other kit, a rapid antibody diagnostic test (RDT) kit for the COVID-19 virus, also won CE marking approval from the EU earlier.

Through a distribution agreement with South Korean in-vitro diagnostic company Humasis, RDT kits will be launched in various countries, including Europe, according to Celltrion.

The new antibody detection test is most suitable for identifying acute or early infection of the COVID-19 virus, Celltrion said.


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