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Sinopharm News

GeneoDx Detection Kits Get EU Approval

Post Time:2020-03-21 [Large Middle Small] View:

On March 14th, Sinopharm CNBG Shanghai GeneoDx got the EC Declaration of Conformity of their self-developed 2019-nCoV nucleic acid detection kits (real time PCR), meaning the detection kits meet the requirements of European medical device conformity and are entitled to enter the EU market.

Sinopharm CNBG GeneoDx responded immediately to the outbreak of COVID-19 and started R&D of its detection kits. It was the first to develop COVID-19 nucleic acid detection kits and submit to the China CDC for testing, and was among the first suppliers of such detection kits recommended by the National Health Commission’s Guidance for Novel Coronavirus Pneumonia Laboratory Testing Technology, and among the first ones to obtain the medical device registration from the National Medical Products Administration.

During the epidemic, Sinopharm CNBG GeneoDx has been in full production and supplied detection kits to the front lines in all provinces to ensure the prevention and control of the epidemic, playing an essential role in precision diagnosis and safeguarding national health. 

As an enterprise with a centenary history, Sinopharm CNBG acted proactively in terms of diagnosis, treatment, R&D in vaccines and antibodies, staging its responsibility and the sense to undertake as the “national team” of bio-products. Sinopharm CNBG first came up with the convalescent plasma therapy and set the criteria for making the convalescent plasma. It dispatched 44 plasma collecting teams and set up 50 plasm collecting spots. The outcome of this therapy was recognized by the State Council Joint Prevention and Control Mechanism.

As the pandemic continued to spread globally, Sinopharm CNBG dispatched an expert to join the team set up by China Red Cross Society to aid Italy onsite in fighting the pandemic. With GeneoDx’s detection kits approved with CE, it is now able to assist the world in this fight.