BGI Covid-19 Virus Detection Kit Receives FDA Emergency Use Authorization
On March 27, BGI announced that its new coronavirus nucleic acid detection kit has obtained the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA). It is the first company in China to obtain this authorization. According to the US “Guidelines for the Diagnosis and Testing of New Coronavirus Pneumonia in the Public Crisis”, it is possible to enter the US clinical market after obtaining commercial sales to the US clinical market.
As of 18:00 EST on the 26th (6:00 pm Beijing time on the 27th), the number of confirmed cases of COVID-19 in the United States has reached 82,404, which has become the country with the largest number of confirmed cases worldwide.
The new coronavirus nucleic acid detection kit approved by BGI has obtained the medical device registration certificate issued by the China National Drug Administration (NMPA) and obtained the European Union CE certification. BGI claims that the company ’s COVID-19 detection products have obtained EUA, another milestone for BGI to help prevent and control the global epidemic, and help provide the United States with high-quality, high-throughput testing services and the results of nucleic acid testing It can help medical professionals respond quickly and assist in the screening of patients with COVID-19 virus infection, thereby preventing further spread of the infection.
Up to now, BGI has produced more than 7 million copies of the kit, and has completed the detection of COVID-19 virus nucleic acid in nearly 580,000 copies nationwide. This kit is widely used in Wuhan and Hubei to fight the “defense war” and national resumption of production and screening. At present, kit orders have covered 70 countries and regions, and have been shipped to Japan, Brunei, Thailand, the United Arab Emirates, Egypt, Peru and other places.
BGI, as the leading company in the field of gene technology, has accumulated more than 20 years in the field of genomics and infection prevention and control, and has extensive product distribution in the field of pathogen infection detection. It has participated in the SARS epidemic battle in 2003. Since then, in many public health incidents at home and abroad, Huada has provided technical support as soon as possible, committed to deciphering the pathogenic genome, developed diagnostic kits, and provided response plans. This time, BGI responded to the domestic epidemic as soon as possible, and began to develop related kits in early January 2020. The initial R & D was completed in only 72 hours. After passing the strict kit production process and quality control, January 14 officially announced the completion of the development of a new coronavirus nucleic acid detection kit (fluorescent PCR method).
Compared with EU CE certification, the US market has higher barriers to entry. In addition to BGI, Shanghai Scitech Biomedical Technology Co., Ltd. also launched the US EUA application one month ago and was accepted on March 4. It not only includes the latest COVID-19 virus detection kit, but also fully automated nucleic acid extraction. A complete solution including equipment and reagents.