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Antigen self-test kits developed by Orient Gene receive approval for sale

chinadaily.com.cn | Updated: Mar 17, 2022

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A production line of Zhejiang Orient Gene Biotech Co Ltd in Huzhou, East China's Zhejiang province. [Photo/WeChat account: huzhoufabu]

The National Medical Products Administration has given approval to Zhejiang Orient Gene Biotech Co Ltd to sell its COVID-19 antigen self-test kits, according to a notice recently published on the company's website.

Headquartered in Huzhou, East China's Zhejiang province, the company is the first in Zhejiang to obtain the approval.

Antigen detection can be used as a supplement to nucleic acid detection, which is still the primary diagnostic tool for COVID-19, the National Health Commission announced on March 11.

There are presently 12 companies in China including Orient Gene that have received approval to produce self-test kits. The self-test kits developed by Orient Gene have been used in Europe and the United States for more than a year.

According to deputy general manager Tan Jinfeng, the kits can produce a result within 2 to 15 minutes.

Orient Gene is able to produce over 10 million self-test kits daily.

Founded in 2005, Orient Gene specializes in the R&D, production and sales of in vitro diagnostic products.

The company made its initial public offerings on Shanghai Stock Exchange in 2020.

Its main products include POCT instant diagnostic reagents, which are mainly used in the detection of infectious diseases, tumor markers and cardiac marker detection.

Last year, the company's sales revenue reached 10 billion yuan ($1.54 billion), while its net profit hit 4.8 billion yuan. Its exports of the COVID-19 test products accounted for about 15 percent of the nation's total in 2021.