FDA Gives Emergency Use Approval for Coronavirus Diagnosis Kits to China's BGI
BGI Genomics received a formal Emergency Use Authorization from the US Food and Drug Administration.
BGI Genomics has received an Emergency Use Authorization (EUA) for its SARS-CoV-2 test product, allowing the Chinese giant's kits to be commercially available for clinical use in the United States, the firm announced. The regulatory head had granted its first emergency approval for coronavirus kits on March 21, to California-based Cepheid.
The development marked yet another breakthrough in BGI’s globalization. The Shenzhen-based company was also the first Chinese biotech firm to receive the Free Sales Certificate (FSC) for EU countries amidst the worsening of the outbreak in Western and Southern Europe.
BGI (300676: SH) was amongst the first companies to mass-produce and be granted approval for use of diagnostic kits in China. The firm played an utterly strategic role in China's fight with the epidemic, quickly producing hundreds of thousands of units in the initial stages. The first batch of 100,000 kits from the company assisted the frontline of pathogen detection in Hubei province, the first epicenter of the epidemic. Following from that, multiple thousands of kits were deployed to respond aggressively to the spread of the virus in the rest of China.
Previously the company initiated several other overseas initiatives in Japan, Serbia, and Italy – and even in Iraq and Iran, in a move to address the growing need outside China.
"There is a massive shortage of COVID-19 (Coronavirus) test kits in the US, as cases continue to skyrocket in places like Seattle and New York City," reported a US media group. BGI Genomics could play a crucial role in the US's fight with the epidemic as well.