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 are currently being distributed to more than 50 countries and regions worldwide

- Highly sensitive and quick test with 3-hour turnaround time

CAMBRIDGE, Mass., March 18, 2020 /PRNewswire/ --BGI Genomics. Co. Ltd. (SZSE:300676) and US subsidiary BGI Americas Corp., today announced that its Real-Time Fluorescent RT-PCR test for detecting SARS-CoV-2 is now commercially available in the United States. With the updated guidance from FDA issued on March 16, BGI's detection kit is eligible to be used immediately to expedite clinical testing for the novel coronavirus.

BGI is submitting a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for itsSARS-CoV-2 testand 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.

About EUA

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV has not been FDA cleared or approved. However, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About BGI Genomics Co Ltd.

BGIwas founded in 1999 with the vision of using genomics to benefit humanity and has since become one of the largest genomics organizations in the world. With a focus on research and applications in the healthcare, pharmaceutical, conservation and environmental fields, BGI has a proven track record of innovative, high-profile research that has generated over 1,600 publications. BGI Genomics is an independent division of BGI Group and was listed on theShenzhen Chi-Next exchange inJuly 2017. BGI Genomics' goal is to make state-of-the-art genomics highly accessible to the global research community and clinical markets by integrating the industry's broadest array of leading technologies, including BGI's own DNBSEQ technology platforms, economies of scale, and expert bioinformatics resources. BGI Genomics also offers a wide portfolio of transformative genetic testing products across major diseases, enabling medical providers and patients worldwide to realize the promise of genomics-based diagnostics and personalized healthcare.

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SOURCE BGI

More:
BGI's RT-PCR SARS-CoV-2 Test to Detect Novel Coronavirus Now Commercially Available for Clinical Use in the United States - Yahoo Finance

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