BGI Receives Health Canada Authorization to Supply SARS-CoV-2 RT-PCR Test in Canadian Market

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May 06, 2020, 13:32 ET

TORONTO, May 6, 2020 /PRNewswire/ -- BGI Genomics announced today that its subsidiary BGI Americas Corporation has received authorization under Interim Order from Health Canada to supply its Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 in the Canadian market. The testing kit is part of an integrated solution that includes automated extraction methods to support fast and accurate detection of SARS-CoV-2 around the world.

BGI Genomics and MGI, members of the BGI Group, are jointly providing a high throughput, clinically validated workflow to address major bottlenecks for large-scale COVID-19 testing. The solution includes BGI's Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2, which is the authorized device by Health Canada, as well as MGI's MGIEasy Nucleic Acid Extraction Kit and MGISP-960RS Automated Sample Preparation System.

Both BGI and MGI have existing local entities and business operations in Canada, allowing the companies to deploy immediate local resources for establishing supply chain and customer service to ensure successful adoption of the testing solution in clients' laboratories.

"BGI's RT-PCR kit is one of the most widely recognized molecular products for SARS-CoV-2 detection by global regulatory agencies," said Yin Ye, CEO of BGI Genomics. "It is another testament to our strong commitment to enabling safe and effective COVID-19 testing on a global scale."

BGI's highly-sensitive RT-PCR testing kit, which can return results within three hours, detects the RNA of SARS-CoV-2 extracted from a wide range of respiratory samples. The kit is validated on a number of RT-PCR instruments with broad adaptability. It features

High sensitivity: Limit of detection as low as 100 viral copies/mL
High specificity: No cross-reactivity with 54 human respiratory pathogens
Ease of use: All-inclusive with pre-mixed reaction reagents
Easy interpretation: Analysis of one target with well-defined controls

The authorization includes MGI's MGIEasy Nucleic Acid Extraction Kit as a validated method for viral RNA extraction, which is currently in abundant supply worldwide and addresses a severe sample preparation bottleneck for widespread testing. In addition, MGI's robotic sample preparation system significantly improves throughput and reproducibility. The combination of the MGI products enable processing of 192 samples in 80 minutes, a major increase in productivity compared to manual processing.

"The integrated SARS-CoV-2 testing workflow offers our customers unique ability to scale testing efforts in Canada," added Stephen Rogers, BGI/MGI's Country Manager in Canada. "BGI and MGI are committed to supporting Canadian labs with our tools to tackle the COVID-19 pandemic."

The integrated solution of MGI sample preparation with BGI's RT-PCR kit is part of a comprehensive solution BGI Group has introduced for rapidly scaling up diagnostic testing — the Huo-Yan or "Fire Eye" labs. The Fire Eye Laboratory model that demonstrated its early success in Wuhan, China, where the virus was first identified, is now being implemented in Europe, the Middle East, Asia and around the world. Fire Eye laboratories combine the best of BGI Group expertise, with the most recent labs launched in Saudi Arabia and Australia.

BGI Genomics currently has a manufacturing capacity of 2 million RT-PCR tests per day and is fulfilling international orders from more than 80 countries and regions around the world.

BGI's RT-PCR Test for Detecting SARS-CoV-2 is one of the most reliable and widely used testing methods available, with over 20 million tests already performed. In 2020, BGI's testing kit for SARS-CoV-2 received emergency approval from China's National Medical Products Administration (NMPA) on January 26, followed by the European CE-IVD marking on February 24, the U.S. FDA-issued Emergency Use Authorization (EUA) on March 26, Japan's PMDA approval on March 27, and Australia's TGA approval on April 10.

SOURCE BGI Group