Biotest Biotech: The antigen for COVID-19 has been authorized by the FDA for emergency use!

On December 26, Hangzhou Biotest Biotech announced that the COVID-19 antigen home self-test test kit (Advin COVID-19 Antigen Test @Home) produced by Advin, has passed laboratory verification and clinical research evaluation, the performance meets the requirements of the relevant standards, and has now obtained the EUA (Emergency Use Authorization) from the US Food and Drug Administration (FDA).

According to reports, the reagent is suitable for over-the-counter (OTC) testing at home and other non-laboratory locations. It is easy to operate, and the test result can be obtained in only 10 minutes. The acquisition of this EUA means that Hangzhou Biotest Biotech's COVID-19 antigen products will open relevant markets in the United States and countries and regions that recognize EUA certification.

According to the "Wall Street Journal" report, in addition to providing test kits, the US government also plans to set up 15,000 free community testing stations across the country. With the resumption of new crown testing in the United States, the market began to expect that in the winter of 2022, further growth in global demand for antigen detection kits will be evident.

Prior to this, the United States suspended the distribution of free COVID-19 test kits temporarily. This is due to the government having to ensure that there are enough test kits to deal with the possibility of a surge in COVID-19 cases in winter. After entering the winter, the COVID-19 in the United States has quickly counterattacked: in the past few weeks, the number of confirmed cases of COVID-19 in the United States has increased by 45% to 50% every week, and the number of deaths has increased by 60% every week; nearly 10% of the counties in the United States are at high risk.

The market price of antigen reagents in the United States is still relatively high. According to the contract information disclosed by iHealth, the purchase price of the US government’s COVID-19 household antigen test is 2.65 US dollars per piece (about RMB 18.6 per piece). This has also attracted the attention of other Chinese IVD companies.