BGI's Real-time Fluorescent RT-PCR Kit for Detecting 2019-nCoV eligible for WHO Emergency Use Listing

SHENZHEN,China,May 12,2020 -- BGI Genomics announced that its Real-time fluorescent RT-PCR kit for detecting 2019-nCoV has been listedas eligible for World Health Organization (WHO) procurement under the WHO Emergency Use Listing (EUL) process.

The EUL is a risk-based procedure for assessing and listing unlicensed vaccines,therapeutics and in vitro diagnostics (IVDs) for use primarily during public health emergencies of international concern (PHEIC) but also in other public health emergencies if appropriate. On January 30,2020,WHO declared the outbreak of COVID-19 to be a public health emergency of international concern,and initiated EUL for In vitro diagnostics (IVDs) Detecting SARS-CoV-2 Nucleic Acid. BGI is the first Chinese company listed as eligible under WHO EUL processfor SARS-CoV-2 detection.

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 bronchoalveolar lavage fluid (BALF) and throat swabs.

Advantages of BGI's test include:

High sensitivity– Limit of Detection at 100 copies/mL in BALF and 150 copies/mL in throat swabs

High specificity – No cross-reactivity with 54 human respiratory pathogens

Fast TAT – Sample to result in 3 hours

Easeof use – All inclusive with pre-mixed reaction reagents

Easy interpretation – Analysis of one target with well-defined controls

BGI's RT-PCR kit for Detecting 2019-nCoV is one of the most reliable and widely used testing kits,with over 20 million tests performed worldwide. BGI's RT-PCR testing kit for SARS-CoV-2 received emergency approval from China's National Medical Products Administration (NMPA),followed by the European CE mark,the U.S. FDA Emergency Use Authorization (EUA),Japan's PMDA approval,Australia's TGA approval,and Health Canada Authorization.

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