Real-Time Fluorescent RT-PCR SARS-CoV-2 Test launched in US after application for emergency use authorization.- BGI Genomics
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Published:20th Mar 2020
BGI Genomics and US subsidiary BGI Americas Corp., 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 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.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.