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Xiamen biotech firm's testing reagents meet FDA's standards

chinadaily.com.cn| Updated: April 8, 2022 L M S

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A file photo of Xiamen Boson Biotech Co's COVID-19 antigen self-test kits. [Photo/WeChat account: xiamen_swj]

Xiamen Boson Biotech Co produced COVID-19 antigen self-test kits that have been approved for emergency use authorization (EUA) by the Food and Drug Administration (FDA) on April 6, marking the company's progress in the American market.

At the end of 2021, Boson Biotech was invited to participate in the RADx program, which was organized by the National Institutes of Health (NIH) to support the FDA's EUA for COVID-19 self-test products in order to alleviate the severe and complex outbreak of the pandemic.

In the program, the company produced antigen self-test kits that have undergone comprehensive performance validation by Emory University and MRI Global laboratories, as well as clinical studies organized by Toolbox Medical Innovations, which proved that the products meet the requirements of FDA standards and have been approved to enter the American market.

Since the beginning of the COVID-19 epidemic, Xiamen's Xiamen biopharmaceutical enterprises, represented by Boson Biotech, have stepped up efforts to go global.

Statistics show that the exports of Xiamen testing reagents reached 3.72 billion yuan ($584.73 million) in the January-February period, ranking fourth in trade volume in the country, with the exports mainly sold to the European market.

Why Xiamen

  • About Xiamen

    Xiamen is one of the most economically competitive cities in China and was one of the first Special Economic Zones on the Chinese mainland. As a vice-provincial city independently listed on the State development plan, it has provincial-level authority in economic administration and local legislative power. In 2010, the Xiamen SEZ was expanded to cover the entire municipality. Today, Xiamen is a modern and international port city.

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