Founded in 1994, Beijing BGI-GBI Biotech Co., Ltd. (GBI) is the core subsidiary of BGI(SZSE Stock Code:300676) which is one of the largest genomic organizations in the world. GBI mainly focuses on the business including R&D, manufacture and sales of In Vitro Diagnostic (IVD) kits and clinical lab services. GBI is among the first batch of IVD enterprises who have obtained GMP certificate in China. All the blood-screening products have 100% passed inter-batch inspection of National Medical Product Administration (NMPA) for over 20 years in a row, and GBI has repeatedly ranked first with full marks in clinical quality assessment organized by the National Center for Disease Control and Prevention (NCDCP).

To improve people's health, we innovate medical detection model and enhance the efficiency of diagnosis and treatment. GBI is one of IVD enterprises which possesses the most comprehensive platforms. So far GBI has established methodological platforms such as mass spectrometry, nucleic acid testing, ELISA, CLIA, CMIA, POCT, gene sequencing and so on covering fields like reproductive health, cancer screening and medication, regular diseases, infectious diseases, blood screening, and nutrition detection. We have independently developed more than 100 categories of diagnostic kits approved by NMPA and have obtained EU-CE Markings for most products. In 2018, GBI undertook National S&T Major Project of China and One Belt One Road national research task. We have deep cooperation with hospitals in China, and we are also one of the largest reagent suppliers of large-scale physical examinations and healthcare centers. Not only have we focused on people's livelihood for a long run, GBI has also played an important role in providing aids against major disasters such as SARS, H1N1, and COVID-19. 


Mission

Advanced Diagnostic Technologies for Better Healthcare

Vision

Delevop the diagnostic technology industry, and revitalize the national life science.

Values

Delevop the diagnostic technology industry, and revitalize the national life science.

Criteria

All actions are standardized;

All actions are recorded;

All actions are monitored;

All actions are traceable.

History

INDUSTRY EXPERTS

INDUSTRY EXPERTS

1994
1994

Founded in Beijing, devoted to research HIV, HCV, HEV and EBV diagnostic kits.

1996
1996

Undertook the research and development of HIV antibody ELISA detection kit in the Country 9th Five-Year Scientific and Technological Project.

1997
1997

Innovated HIV detection kits, ending the history of no domestic detection kits.

1998
1998

Joined in and provided financial support for the International Human Genome Project.

1999
1999

The Beijing Genomics Institute (Predecessor of BGI Group) is founded.

2000
2000

Qualified GMP certification.

2001
2001

Innovated TP antibody ELISA diagnostic kits and won the new drug certification and patents in China.

2002
2002

Be awarded 'High & New Technology Corporation'.

2003
2003

Innovated the SARS diagnostic kit approved by CFDA and denoted 300,000 detection reagent kits to Chinese government.

2004
2004

HIV1+2 type ELISA diagnostic kit had been funded by Beijing High-New Achievements Transformation Project and got the Technology Innovation Fund for small and medium-size enterprises of Ministry of Science and Technology.

2005
2005

Won the bid of Special Public Health Funds for Aids Prevention and Control Project organized by National Health Commission of China.

2006
2006

Accessed to national medical equipment production license and ranked the first in the clinical quality evaluation of HIV antibody diagnostic reagents organized by CDC.

2007
2007

Passed ISO9001: 2000 Quality System Certification and developed Array-ELISA, a new innovation.

2008
2008

Passed the field certification of category III and II IVD reagents organized by SFDA and Beijing FDA.

2009
2009

Lead in developing the new H1N1 influenza virus diagnostic kits, Influenza A virus diagnostic kit and completed the detection of the first imported case in China. About 20 products such as thyroid function detection kit, gonadal hormone detection kit, insulin detection kit, liver fibrosis diagnostic kit had been certificated, which greatly enriched the product list and improve the company market competitiveness.

2010
2010

Passed the GMP field inspection and had the new GMP certification.

2011
2011

Got the Certificate of Pharmaceutical Product of HIV, HCV, TP, HBsAg. Some products had passed the Quality Management System Examination for Category 3 products by CFDA.

2012
2012

Awarded the certificates of nucleic acid diagnostic kits for EVs, HBV, TB virus and ELISA diagnostic kits for HEV and HAV.

2013
2013

Awarded the certificates of 16 type and 18 type HPV nucleic acid diagnostic kit.

2014
2014

Awarded the certificates of ToRCH IgG antibody, ToRCH IgM antibody, TB and the forth-generation HIV antigen and antibody diagnostic kits.

2015
2015

Developed the new pattern of combination sales of kits and third-party detection laboratory and awarded ISO13485 Quality System Certification.

2016
2016

Awarded the certificates of seventeen tumor markers which has been applied for the detections over 5 million samples, and also the certificates of EGFR and K-ras detection kits from nucleic acid platform in June 2016.

2017
2017

Undertook the hydatid disease antibody detection project of Tibet by detecting over 830,000 samples and won the 'Best Quality Award' from BGI.

2018
2018

Took part in the 'Zhejiang Province Two Cancer Screening Project' and 'M. tuberculosis Major Specific Project' of the 13th Five-year Plan of Chinese government, R&D diagnostic kits for sudden acute infectious diseases, as the responsible unit in Chinese major national S&T projects, participated in research on improving the ability of prevention, control and disposal of important infectious diseases in China's peripheral areas and new HBV detection reagents and registration declaration organized by the Medical Science and Technology Development Research Center of CDC.

2019
2019

To promote school-enterprise cooperation, our company (GBI) signed an industry-university research cooperation agreement with the School of Public Health of Lanzhou University. GBI and held the establishment ceremony of the 'Lanzhou University Public Health and Preventive Medicine Teaching Research and Innovation Practice Base'; Human Immunodeficiency Virus (HIV) Antigen and Antibody Diagnostic Kit (ELISA), sample release agent, cleaning solution, and substrate liquid for automatic immunoassay system to obtain medical device registration certificate. GBI new product for Time of Light Mass Spectrometry (TOF) instrument and system are also lunched.

 2020
2020

Passed external quality assessment of the SARS-COV-2 antibody test in the national blood center laboratory organized by China's National Health Commission; Achieved the first registration certificate of SARS-CoV-2 Virus IgG/IgM Antibody Detection Kit (ELISA), issued by China's National Medical Products Administration (registration certificate number: 20203400567). 

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