Saturday, April 4, 2020
Breaking Medical Device Industry News

BGI’s RT-PCR SARS-CoV-2 Test to Detect Novel Coronavirus Now Commercially Available for Clinical Use in the United States

Rapid and Scalable RT-PCR Assay is Pending Approval for Emergency Use Authorization - BGI's Test Already Has Approvals Through CE-IVD and China's NMPA - Kits Currently Being Distributed to More Than 50 Countries and Regions Worldwide - Highly Sensitive and Quick Test with 3-Hour Turnaround Time

Saturday, April 4, 2020

BGI is submitting a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its SARS-CoV-2 test and expects to receive formal EUA in the near future. BGI has been in regular communication with the FDA about its testing data since submitting information to the agency more than a week ago.

“We appreciate the FDA’s move to open up the market for our diagnostic test kits,” said BGI Genomics CEO Yin Ye. “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 accurate diagnosis.”

BGI has been on the forefront of testing for SARS-CoV-2. Following the outbreak of the novel coronavirus in China, BGI was among the first few companies that developed the diagnostic test 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 quickly scaled up manufacturing and currently has a daily capacity of up to 300,000 reactions per day. BGI 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 50 countries and regions around the world.

BGI is bringing its full genomics expertise and resources to the fight against the 2019 novel coronavirus around the world. BGI’s long history of responses to public health crisis events includes decoding the genome of the SARS virus in 2003 and developing the virus detection kit in 96 hours, and helping fight the Ebola outbreak in 2014 in West Africa, where BGI quickly set up a front-line laboratory in Sierra Leone and helped the local team to develop Ebola virus detection kits.

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