Boson Biotech’s Rapid SARS-CoV-2 Antigen Test Card gets EUA from FDA

On April 6, it was reported that the Rapid SARS-CoV-2 Antigen Test Card produced by Xiamen Boson Biotech Co., Ltd. has obtained the FDA Emergency Use Authorization (EUA).

This is the sixth Chinese company to be certified after ACON Biotech, Orient Gene Biotech, Andon Health, Core tests and PHASE Scientific.

In November 2021, Boson was invited to participate in the RADx program organized by the National Institutes of Health (NIH). The program established an independent testing and evaluation team to provide independent verification, clinical research and data collection for the products of participating manufacturers to support FDA's emergency use authorization application for OTC new coronavirus testing products. The program is mainly aimed at testing products that have been mass-produced and sold outside the United States to address the lack of OTC new coronavirus testing products in the United States.

Boson’s Rapid SARS-CoV-2 Antigen Test Card (Home Test) has undergone comprehensive performance verification by EmoryUniversity and MRIGlobal laboratory, as well as clinical research organized by Toolbox Medical Innovations. The product performance meets the relevant FDA standards. After a rigorous review by the review team, it was approved for emergency authorization and can be sold in the US market.

Boson’s Rapid SARS-CoV-2 Antigen Test Card (Home Test) have been sold in large quantities to Europe, Southeast Asia, Australia, Canada and other countries. It has won the favor of the majority of users with excellent quality and service, contributing "China power" to the global epidemic prevention and control.