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
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.
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. ยง 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
About BGI Genomics Co Ltd.
BGI was 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 the Shenzhen Chi-Next exchange in July 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