BGI Receives Health Canada Authorization

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; and
• 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.

About BGI Genomics Co Ltd.

BGI was founded in 1999 with the vision of using genomics to benefit humanity and has since become one of the largest genomics organizations in the world. With a focus on research and applications in the healthcare, pharmaceutical, conservation and environmental fields, BGI has a proven track record of innovative, high-profile research that has generated over 1,600 publications. BGI Genomics is an independent division of BGI Group and was listed on the Shenzhen Chi-Next exchange in July 2017. BGI Genomics’ goal is to make state-of-the-art genomics highly accessible to the global research community and clinical markets by integrating the industry’s broadest array of leading technologies, including BGI’s own DNBSEQ technology platforms, economies of scale, and expert bioinformatics resources. BGI Genomics also offers a wide portfolio of transformative genetic testing products across major diseases, enabling medical providers and patients worldwide to realize the promise of genomics-based diagnostics and personalized healthcare.

About MGI

MGI, a subsidiary of BGI Group, is committed to building core tools and technology to lead life science through intelligent innovation. Based on its proprietary technology, MGI produces sequencing instruments, reagents, equipment and related products to support life science research, agriculture, medicine and healthcare. MGI is a leading producer of clinical high-throughput gene sequencers, and its multi-omics platforms include sequencing, mass spectrometry, medical imaging and laboratory automation. Providing real-time, comprehensive, life-long solutions, its vision is to enable effective and affordable healthcare solutions for all. More information: