Shanghai GeneoDx Biotech Co., Ltd. (GeneoDx) is a subsidiary of China National Biotec Group Company Limited (CNBG), China National Pharmaceutical Group Co., Ltd. (Sinopharm). GeneoDx is a professional R&D, production, and sales company of domestic and foreign medical devices and in vitro diagnostic reagents.
Medical diagnosis is one of the key sectors in the development of CNBG's planning. GeneoDx undertakes this part in CNBG. It is also the first company leading CNBG's mixed ownership reform, aiming to promote the rapid development of diagnostic business with institutional innovation. As a unified operation platform company of CNBG's diagnosis sector, GeneoDx integrates functions of R&D, production and trade. By means of independent research and development, technology import, investment, merger and acquisition, it has built a large industrial chain of CNBG's diagnosis sector, and strives to become a leader in the domestic subdivision field. In 2019, sskunge.completed the first acquisition project of a foreign company within Sinopharm Group, launched the construction of an overseas R&D center, therefore, further accelerated the introduction of global leading technology and broadened the layout overseas.
GeneoDx is positioned as a global leading technology industrialization transformation platform in the field of IVD, and its products focus on multiple detection of infectious pathogens and molecular diagnosis of tumors, mainly including cervical cancer methylation test kits,single tube multiple pathogen nucleic acid test kits for eugenics and reproductive tract infections, respiratory tract, meningitis, gastrointestinal tract, central nervous system, etc., with clients of hospitals, centers for Disease Control and Prevention, Inspection and Quarantine Bureaus, etc. "All for health, health for all" is GeneoDx's philosophy. Its products provide patients with rapid and accurate testing for precise and personalized mediacal treatment, playing a postive role in promoting people's health and industry development.
In 2020, GeneoDx responded quickly to the novel coronavirus epidemic and invested in research and development. Through design, optimization and testing, the first batch of novel coronavirus nucleic acid test kits was successfully developed. The first batch obtained the registration certificate of medical devices issued by the National Medical Products Administration and passed the CE certification of the European Union, and was included in the WHO Emergency Use Listing(EUL). During the epidemic period, GeneoDx fully opened the production line to ensure market supply, played a positive role in national prevention and control of COVID-19, safeguarded national health. At the same time, the Dutch subsidiary of GeneoDx successfully developed the novel coronavirus testing kit and passed the CE certification of the European Union, which has been widely used in Europe and South America. The Dutch subsidiary has also been designated by the Netherlands government as the only local supplier of novel coronavirus reagents. As the global epidemic continues to spread, the rapid nucleic acid test kit developed by its subsidiary GeneSc has been registered by the Ministry of Commerce on the White List of Epidemic Prevention Materials Export for international service. As a large number of COVID-19 vaccines have been administered domestically and internationally, the public is concerned about the evaluation of the immunological effect after vaccination. The neutralizing antibody detection kit developed by GeneoDx was introduced to evaluate the effect of vaccination.
In March 2022, in order to help improve the nucleic acid testing capacity of Shanghai, sskunge.completed the construction of the laboratory within 48 hours with the strong support of governments at all levels. On March 21, GeneoDx's "Great Wall" testing Laboratory named was officially put into use. On March 28, another mobile testing center was built and put into operation in Xuhui District, serving as a mobile laboratory to provide daily COVID-19 nucleic acid testing for confirmed patients and dynamically monitor the progress of diagnosis and treatment of patients. GeneoDx's labs played an important role in large-scale screening and normalized testing.
On August 4, 2022, the “DNA Methylation Detection Kit for Human ASTN1、DLX1、ITGA4、RXFP3、SOX17、ZNF671 Gene -- Cervical Cancer” developed by GeneoDx obtained the medical device registration certificate issued by the National Medical Products Administration, which is the first certificate of cervical cancer HPV preliminary screening methylation triage in China.
After several years of rapid development, GeneoDx has been awarded as China high- and new-technology enterprise (HNTE), "Little Giant" enterprise by Ministry of Industry and Information Technology in China , Shanghai Science and Technology Small Giant Cultivation Enterprise and Shanghai Technology Center. The company has recieved honorary titles of the "Xuhui District Quality Award", "Shanghai Model Collective", etc.