BGI Receives FDA Authorization for Real-Time SARS-CoV-2 Test

BGI Genomics and its US subsidiary BGI Americas announced the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its RT-PCR kit for detecting SARS-CoV-2.

BGI's test can return results within three hours. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in bronchoalveolar lavage fluid (BALF) and throat swabs.

"The authorization of our diagnostic test for COVID-19 in the US will provide high-quality, high-volume testing capabilities to the US, and enable medical professionals to respond quickly to diagnose patients, preventing further spread of infection," said Ye Yin, CEO of BGI Genomics. "As one of the first responders to the outbreak in China, we quickly scaled up our production and have deployed large numbers of kits for testing in China and globally in countries where our test kit has been approved. We are committed in bringing rapid, accurate testing capabilities on a massive scale to bolster detection efforts throughout the United States and globally in order to fight the spread of this disease."

Advantages of BGI's test include:

• Limit of Detection at 100 copies/mL in BALF and 150 copies/mL in throat swabs
• No cross-reactivity with 54 human respiratory pathogens
• Sample to result in 3 hours   
• All-inclusive with pre-mixed reaction reagents
• Analysis of one target with well-defined controls

Following the outbreak of the novel coronavirus in China, BGI was among the first few companies to have developed diagnostic tests that received emergency approval from China's National Medical Products Administration (NMPA) on January 26, 2020, followed by CE-IVD marking on March 2, 2020.  BGI currently has a daily manufacturing capacity of 600,000 reactions and is actively scaling up to meet rapidly growing global demand. As of March 22, BGI has produced a total of 4.72 million tests. The company has performed over 500,000 SARS-CoV-2 tests in its own central laboratories in China and is distributing its SARS-CoV-2 detection kits to more than 70 countries and regions around the world. BGI has donated over 130,000 tests since the beginning of the outbreak to regions and countries most in need of testing.

BGI's Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is the first FDA-approved product manufactured in China. It is also BGI's first FDA-approved medical device.

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