Therapy Areas: Respiratory
BGI gets FDA EUA for RT-PCR kit to detect SARS-CoV-2
30 March 2020 -

Diagnostic test company BGI Genomics Co Ltd (SZSE:300676) and its US subsidiary BGI Americas Corp on Friday jointly announced the receipt of US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its SARS-CoV-2 RT-PCR detection kit.

The company added that the highly sensitive RT-PCR 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.

In addition, the company's test includes detection at 100 copies/m in BALF and 150 copies/ml in throat swabs, no cross-reactivity with 54 human respiratory pathogens, sample to result in three hours, pre-mixed reaction reagents as well as analysis of one target with well-defined controls.

As of 22 March, the company has produced a total of 4.72 million tests, performed over 500,000 SARS-CoV-2 tests in its own central laboratories in China, distributed its SARS-CoV-2 detection kits to more than 70 countries around the world and donated over 130,000 tests since the beginning of the outbreak to regions most in need of testing. It has a daily manufacturing capacity of 600,000 reactions.

Following the outbreak of the COVID-19 in China, the company was among the first few companies to have developed diagnostic tests that received emergency approval from China's National Medical Products Administration (NMPA) as well as Europe's CE-IVD.



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