Chinese big gene: 140 thousand person gene project without foreign agency

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 Chinese big gene: 140 thousand person gene project without foreign agency


On the evening of October 28th, the Chinese big gene replies to the inquiry letter. According to Huada Gene, a large sample case-control study of Chinese women with unipolar depression, a joint international scientific research project (hereinafter referred to as the Depression Project), Huada Gene said that Shenzhen Huada Gene Technology Services Co., Ltd. (hereinafter referred to as Huada Science and Technology), a subsidiary of Youhua Gene, and Oxford University are several in China. Hospital development.

The project is divided into two parts, the first part is sample and phenotypic data collection; the second part is the collection of samples for genomic analysis, through case-control studies to reveal the pathogenesis of depression. The first part is about sample collection and phenotypic data analysis. Huada Technologies has not participated in this work. Huada Technologies has participated in the second part of genomic analysis. It has carried out database building, sequencing and analysis in Shenzhen, and delivered part of the test data to the project partners.

On September 7, 2015, the Ministry of Science and Technology decided that Huada Science and Technology had committed illegal acts in the implementation of the above-mentioned projects: Huashan Hospital of Huada Science and Technology and Fudan University carried out international cooperation research on human genetic resources in China with Oxford University of England without permission, and Huada Science and Technology took part of human genetic resources information without permission. Deliver from the Internet.

During the rectification period, Huada Science and Technology suspended international cooperation involving human genetic resources in China. During the period, 12 projects were terminated because of reasons. The total amount of contracts affected by these projects accounted for less than 0.2% of Huada Genes operating income in 2015, which had a slight impact on the overall performance of listed companies. During the rectification period, the domestic projects of Huada Science and Technology were carried out normally, and the international cooperation which did not involve human genetic resources was also carried out normally.

In response, the Ministry of Science and Technology has approved Huada Science and Technology to resume international cooperation on human genetic resources in China after checking and accepting the report.

The other item is 140 thousand Chinese gene big data. Huada Gene Response said, first, 140,000 Chinese Gene Big Data project without foreign partners. At present, the study has been successfully completed. The main research results are published in the international academic journal Cell, entitled Noninvasive Prenatal Genomics Research Revealing Multiple Complex Shapes of Genetic Association, Viral Infection Patterns and Chinese Population History and the analysis methods using such data.

The foreign authors signed in this paper are academic advisors. They have not been involved in any analysis of the original data. They have only made intellectual contributions to the design of scientific research ideas and algorithms.

Secondly, the Huada research team strictly abides by the Interim Measures for the Management of Human Genetic Resources and the norms of bioethics on the right to know about the study of 140,000 Chinese Gene Big Data. Prior to noninvasive prenatal genetic testing, the subject will sign an informed consent to confirm whether they agree with the sample and data for scientific research. The study selected 140,000 large Chinese genome data from subjects who agreed to provide samples and data for scientific research. This study discloses the results of group analysis, does not contain any identifiable personal identity information, there is no risk of revealing personal privacy.

Thirdly, on the issue of data security, this study was completed in China. Samples and data are kept in Shenzhen National Gene Bank, and there is no outbound situation of genetic resources data.

Fourthly, the construction of Shenzhen National Gene Bank Bio-Sample Bank has been approved by the Ministry of Science and Technology, and a complete and strict data security and privacy protection system has been established, and the whole process supervision has been carried out. It has passed the on-site evaluation of ISO/IEC27001:2013 information security management system, and the certification of national information security level protection level 3.

Before the Shenzhen Stock Exchanges inquiry, the website of the Ministry of Science and Technology for the first time announced six administrative penalties for human genetic resources. Six tickets were issued to the units concerned as early as 2015, 2016 and 2017, involving the unauthorized transfer of some human genetic resources information from the Internet, the unauthorized use of 5165 human genetic resources (human serum) as canine plasma for illegal exit, and the development of scientific research activities beyond the scope of examination and approval. The units involved include Shenzhen Huada Gene Technology Service Co., Ltd. (hereinafter referred to as Huada Science and Technology), Huashan Hospital Affiliated to Fudan University, Suzhou Yaoming Kangde New Drug Development Co., Ltd. (hereinafter referred to as Yaoming Kangde, 603259), Kunhao Ruicheng Pharmaceutical Research and Development (Beijing) Co., Ltd., and Xiamen Aide Biomedical Technology Co., Ltd. Ltd (hereinafter referred to as aide biology, 300685), AstraZeneca investment (China) Co., Ltd. The so-called human genetic resources refer to the human genome, genes and their products of organs, tissues, cells, blood, preparations, recombinant deoxyribonucleic acid (DNA) constructs and other genetic materials and related information. Source: surging news editor: Qiao Jun Jing _NBJ11279

Before the Shenzhen Stock Exchanges inquiry, the website of the Ministry of Science and Technology for the first time announced six administrative penalties for human genetic resources. Six tickets were issued to the units concerned as early as 2015, 2016 and 2017, involving the unauthorized transfer of some human genetic resources information from the Internet, the unauthorized use of 5165 human genetic resources (human serum) as canine plasma for illegal exit, and the development of scientific research activities beyond the scope of examination and approval.

The units involved include Shenzhen Huada Gene Technology Service Co., Ltd. (hereinafter referred to as Huada Science and Technology), Huashan Hospital Affiliated to Fudan University, Suzhou Yaoming Kangde New Drug Development Co., Ltd. (hereinafter referred to as Yaoming Kangde, 603259), Kunhao Ruicheng Pharmaceutical Research and Development (Beijing) Co., Ltd., and Xiamen Aide Biomedical Technology Co., Ltd. Ltd (hereinafter referred to as aide biology, 300685), AstraZeneca investment (China) Co., Ltd.

The so-called human genetic resources refer to the human genome, genes and their products of organs, tissues, cells, blood, preparations, recombinant deoxyribonucleic acid (DNA) constructs and other genetic materials and related information.