BGI Genomics’ subsidiary BGI Americas has launched its Real-Time Fluorescent RT-PCR test, which detects SARS-CoV-2 virus that causes coronavirus (Covid-19), in the US for clinical use.
The company’s test is eligible for immediate use, according to the US Food and Drug Administration’s (FDA) recent guidance on expediting clinical testing for the virus.
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An emergency use authorisation (EUA) request will be soon submitted to the FDA by the company for its SARS-CoV-2 test.
BGI Genomics is in constant discussions with the FDA about its testing data since submitting information to the agency more than a week ago.
BGI Genomics CEO Yin Ye said: “We appreciate the FDA’s move to open up the market for our diagnostic test kits. Our goal is to deploy our maximum capability to support efforts to contain the virus worldwide.
“Our technology has been put to the test on the front lines of fighting this novel coronavirus outside the US. We are now bringing rapid and accurate testing capability at scale to bolster detection efforts throughout the US and help more patients receive an accurate diagnosis.”
Following the outbreak of coronavirus in China, BGI Genomics is considered to be at the forefront of testing for SARS-CoV-2.
The company’s diagnostic test received emergency approval from China’s National Medical Products Administration (NMPA) on 26 January, followed by CE-IVD marking on 2 March.
Over 500,000 SARS-CoV-2 tests have been performed by the company in its own central laboratories in China.
Currently, its SARS-CoV-2 detection kits are distributed in more than 50 countries and regions across the world.
The company has increased its manufacturing capacity to up to 300,000 reactions per day to meet the increasing global necessity for coronavirus testing.
BGI expects the FDA’s EUA for its SARS-CoV-2 test in the near future.
