China's leading genome sequencing provider BGI announced Friday that it has received an emergency use authorization from the U.S. Food and Drug Administration (FDA) for its test kits detecting COVID-19.
It means that the product, named Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV, has obtained the qualification to officially enter the clinical market in the United States, according to BGI's announcement.
The Shenzhen-based company finished R&D of the diagnostic test in mid-January, which has previously received emergency approval from China's National Medical Products Administration, followed by CE-IVD marking.
Yin Ye, CEO of BGI, said the FDA's approval of the test kits will help provide high-quality and high-throughput testing services for people in the United States.
"The nucleic acid testing results will assist screening efforts and enable medical professionals to respond quickly, thus helping curb the spread of the virus," Yin said.
BGI has so far produced more than 7 million test kits and completed testings for nearly 580,000 people in China during the epidemic fight as well as the current nationwide resumption of work and production.
The kits are being used in 70 countries and regions including Japan, Brunei, Thailand, The United Arab Emirates, Egypt and Peru.