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BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test with MGI Automated Extraction Methods and Additional PCR Systems

CAMBRIDGE, Mass., April 24, 2020 /PRNewswire/ -- BGI Genomics. Co. Ltd. (SZSE:300676) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for expanding its offering of SARS-CoV-2 RT-PCR Test under emergency use authorization to include the RNA extraction kit and automated liquid handling system made by MGI, as well as additional PCR systems and sample types. BGI now provides a total lab solution for large-scale COVID-19 testing.

Inclusion in the EUA of MGI's viral RNA extraction kit, which is currently in abundant supply in the US, addresses a severe sample preparation bottleneck for widespread testing. In addition, MGI's robotic sample preparation system significantly improves throughput and reproducibility. MGI's MGIEasy Nucleic Acid Extraction Kit and MGISP-960RS Automated Sample Preparation System enable processing of 192 samples in 80 minutes, a major increase in productivity compared to manual processing.

"We now have a one-stop, total solution that makes it easier to ramp up large-scale, community-based testing," said Yin Ye, CEO of BGI Genomics.  He added that the integrated BGI/MGI solution has been effectively used first in China and later on in many countries scaling up testing laboratories to perform up to 50,000 tests a day.

The expanded FDA EUA label also increases the accessibility of test kits to include more types of PCR instruments -- besides Thermo Fisher's ABI 7500 Real-Time PCR System, now ABI 7500 Fast, QuantStudio 5 and Roche LightCycler 480, are also approved for use with BGI's test.

The FDA also expanded the label of the kit to cover more respiratory sample types. Now throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) sample are all compatible with BGI's RT-PCR kit. More flexibility in sample types will increase the clinical utility of the kit to overcome the other testing bottleneck caused by a shortage of sample collection kits.

The amendment announced today expands options for viral RNA extraction from Qiagen's QIAamp Viral RNA Mini Kit to cover MGI's MGIEasy Nucleic Acid Extraction Kit. The kit offers comparable performance along with high throughput and addresses the current supply shortage of extraction kits in the US market.

The Centers for Medicare & Medicaid Services (CMS) on April 15, 2020 announced that Medicare will nearly double payment for lab tests that use high-throughput technologies to rapidly diagnose large numbers of COVID-19 cases. At a time when the United States still urgently needs to enhance its capacity for community COVID-19 testing, the integrated workflow delivered by BGI will allow clinical laboratories to effectively adopt high-throughput testing solutions. 

The integrated solution of MGI sample preparation with the BGI 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, Middle East, Asia and around the world. Fire Eye laboratories combine the best of BGI Group expertise, with the most recent labs launched in the UAE and Sweden.

BGI Genomics and its US subsidiary, BGI Americas Corp., announced on March 27, 2020 that the FDA had issued EUA approval for its RT-PCR kit for detecting SARS-CoV-2. It was the first FDA approved RT-PCR product for COVID-19 testing manufactured in China. BGI Genomics currently has a manufacturing capacity of 2 million tests per day and is fulfilling international orders from more than 80 countries and regions around the world.

BGI's RT-PCR Test for SARS-CoV-2 is one of the most reliable and widely used testing methods available, with over 2 million tests already performed. In addition to the US FDA, BGI's RT-PCR Test for SARS-CoV-2 has been granted emergency approval by Europe's EMA, China's NMPA, Japan's PMDA and Australia's TGA.

About EUA

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV has not been FDA cleared or approved. However, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. ยง 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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. More information:

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:

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Last Updated: 24-Apr-2020