NEW YORK – BGI Genomics said on Friday that its US subsidiary, BGI Americas, has been granted Emergency Use Authorization from the US Food and Drug Administration for its assay to detect SARS-CoV-2, the virus that causes COVID-19.
The assay, called BGI Real-Time Fluorescent RT-PCR Kit for detecting SARS-2019-nCoV, detects the virus in throat swabs and bronchoalveolar lavage fluid in approximately three hours. It is provided with pre-mixed reaction reagents to improve ease of use and focuses on a single target to improve interpretation. The test also has high sensitivity and specificity, with a limit of detection of 150 copies/mL in throat swabs and 100 copies/mL in BAL, and no cross-reactivity with 54 other human respiratory pathogens, the firm said in a statement.
The test can be used with the QIAamp Virus RNA Mini Kit and the Applied Biosystems Real time PCR system 7500 with software v2.0.5, according to instructions for use posted on the US FDA website.
BGI's assay received emergency approval from the National Medical Products Administration in China on Jan. 26, followed by the CE mark on March 2. The company said it is currently scaling up production from a current daily capacity of 600,000 test reactions per day and noted that as of Mar. 22, it had produced 4.72 million tests. It has also performed more than 500,000 tests at its central lab in China.
Ye Yin, CEO of BGI Genomics, said in a statement that the authorization will provide high-quality, high-volume testing capabilities to the US and enable medical professionals to respond quickly to diagnose patients, preventing further spread of infection.
"As one of the first responders to the outbreak in China, we quickly scaled up our production and have deployed large numbers of kits for testing in China and globally in countries where our test kit has been approved," Yin said.
During the outbreak in China, BGI built a lab in Wuhan in five days with throughput for 10,000 tests daily. The model of the Huo-Yan, or "Fire Eye," laboratory was then brought to 12 cities in China, BGI said.
BGI's test is now the first FDA-approved product manufactured in China, and is also BGI's first FDA-approved medical device, the firm noted. BGI's SARS-CoV-2 detection kits are currently distributed in more than 70 countries and regions around the world.