Shenzhen, China., Nov 17, 2020 – BGI Genomics (SZSE:300676) today announced that the Real-time Fluorescent RT-PCR Kit for Detecting 2019-nCoV received registration by National Sanitary Surveillance Agency of Brazil (ANVISA) as a Class III In-vitro Diagnostic device.
The kit is manufactured by BGI Biotechnology (Wuhan), a wholly-owned subsidiary of BGI Genomics. BGI’s highly sensitive test can return results within three hours. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in throat swab and Bronchoalveolar Lavage Fluid (BALF) samples.
BGI has been on the forefront of fight against COVID-19 from the very beginning of the pandemic. BGI was among the first few companies to have developed diagnostic tests that received emergency authorizations from China’s National Medical Products Administration (NMPA) on January 26, 2020. Up to now, the product has received global emergency authorizations including CE-IVD, US FDA, Japan PMDA, Australia TGA, Health Canada, and included in WHO’s Emergency Use Listing. ANVISA approved the RT-PCR kit as a medical device till 2030 in Brazil. It is BGI’s first such product eligible for distribution in Brazilian market.