NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

BGI Genomics

Business Name: BGI Genomics
Business Genre:
Business Description:

One of the world’s largest genomics companies – with a primary forcus in providing high quality sequencing services [1]

City: Cambridge
State: MA
Country: USA
Additional Addresses: Hong Kong, China
Data/Evidence of Effectiveness: Limit of detection is 100 copies/mL (BALF); 150 copies/mL (Throat swabs) [3]. Reactivity/Inclusivity was done by mapping assay to 284 complete SARS-CoV-2 genomes of human host in GenBank and GISAID databases as of March 10th 2020 [3]. No cross reactivity with 54 humar respiratory pathogens [3].
Complimentary Products Needed to Perform Test: Qiagen RNA extraction kits, Roche LightCycler 480, Applied Biosystems 7500 Fast, QuantStudio 5 RealTime PCR Systems [3]
Setting of Care: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a [2].
Current Status / Clinical Development Stage / Expected Milestones: EUA authorized. Waived current good manufacturing practice requirements [2]. Designed for only in vitro diagnostic use [2].
LOD: 150 [8]
Funding & Ownership : Public, Market Cap – 39.53 Billion Chinese Yuan/US$5.54 Billion [4]
Business Model: Offer primarily services for pharmaceutical drug development – including genomic sequencing and mass spectrometry [1].
IP: N/A
History & Origins : Previous experience in genomic and proteomic technologies with customers from all over the world [5].
Date EUA Issued: 03/26/2020 [2] Ammended 04/24/2020 [3]
Sources: [1] https://www.bgi.com/us/ [2] https://www.fda.gov/media/136473/download [3] https://www.bgi.com/us/sars-cov-2-real-time-fluorescent-rt-pcr-kit-ivd/ [4] https://finance.yahoo.com/quote/300676.SZ?p=300676.SZ&.tsrc=fin-srch [5] https://www.bgi.com/us/company/about-bgi/ [6] https://finance.yahoo.com/quote/300676.SZ/profile?p=300676.SZ [7] https://en.wikipedia.org/wiki/BGI_Group [8] https://www.fda.gov/media/136472/download
Organization: Ye Yin (CEO, GM & Director), Yiqing Chen (CFO), Qian Xu (Director of Legal Affairs, General Counsel and Secretary), Zhiping Li (Chief Human Resource Officer), Wei Wang (Chief Medical Officer) [6]
No. Tests Per Day: 192*6 = 1152
Time to Result: Test results within 4 hours for 192 samples [3].
Test Sample Type: Oropharyngeal swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) [3].
Technology Overview: Pre-mixed reaction reagents coupled with automated sample preparation and ORF1ab targeting allow for quick output of results from this technology [3].
Testing Type: Automated sample preparation system and RT-qPCR detection of ORF1ab gene from SARS-CoV-2 [3].
Test Category: RT-PCR
Test Name: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2
Clinical Application & Need: Qualitative test for the detection of SARS-CoV-2 nucleic acids [2].
Age of Company: 1999 [7]

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