Guangdong Introduces Standardization into Life Sciences for the First Time to Make Gene Detection Market Broad

Gene sequencing has been hailed as a high-tech service industry in the field of life sciences, and a science and technology transformation applied science that benefits the human society. It is reported that this is the first time that the Bureau has introduced standardization into the application of life sciences. This move not only accelerates the standardization process for gene sequencing and benefits humans, but also opens up a channel for the industrialization and marketization of gene detection technology.

Gene sequencing market is vast

It is understood that genetic sequencing can truly reflect the genetic information on genomic DNA and reveal the complexity and diversity of the genome in a comprehensive manner. It plays a very important role in life sciences, agricultural breeding, and has a very broad application prospect.

With the deepening of the human genome research, people begin to determine the risk of various diseases through the detection and analysis of genetic defects. At present, there are nearly 2000 diseases worldwide that can be used to predict the risk of disease through genetic testing. It is led by gene sequencing. A new form of medical diagnosis is taking shape. In the United States, there are more than 1,700 institutions providing genetic testing, screening high-risk populations of various serious diseases through large-scale genetic testing, and providing effective prevention, guidance of personalized medicine, and even medical intervention to reduce the incidence of various serious diseases. The rate has reached the scale of 100 billion U.S. dollars and maintains an average annual growth rate of 20%. Data show that about one-fifth of the population in China needs disease-susceptible genetic testing, and at least several hundred billion yuan in market size each year. There are about 20 million pregnant women in China each year. If prenatal screening and prenatal diagnosis are conducted, the coverage rate for birth defects is 50%, and the market size will reach 15 billion yuan. At present, besides arranging China's gene sequencing market, giants of international gene testing have also faced fierce competition in the market for gene sequencing instruments.

Headquartered in Shenzhen, Guangdong, China University of Science and Technology has a world-class production, research, and research team that has formed a development model that promotes the mutual promotion of science, technology, and industry. At present, there are 30 National Ministry of Science and Technology projects in which China National University is conducting research, three national and national 863 and 973 projects, and 700 applied for invention patents. The international human genome, biological gene barcoding, population genetic variation maps and The gene sequencing capabilities and bioinformatics analysis capabilities of rice, silkworm and chicken genome projects and anti-SARS research are at the leading level in the world. In the industrialization of genetic testing, BGI has conducted a series of researches on the genomes of important animals, plants, human health, microorganisms, marine organisms, and bio-energy, and the marketization service network has covered more than 100 countries and regions in the world.

The achievements in the production, research and development of BGI have not only demonstrated the world's leading sequencing capabilities and bioinformatics analysis capabilities, but also laid a solid foundation for China's leading position in the field of genomics research. However, how to transform these scientific research results into a wide range of market applications as soon as possible has become a problem. On the one hand, gene sequencing technology is a new type of applied science covering a wide range of fields including medical health, animal and plant breeding optimization, and scientific and technological services. In the current state of domestic patch management, in particular, there is no clearer With the supervision of relevant laws and regulations, it is difficult for the approval of product marketing. How to use scientific research achievements to form productive forces as soon as possible to occupy the market and compete for international discourse rights is the bottleneck of BGI's efforts to realize the industrialization of scientific and technological achievements.

The standard system is promising

At the end of 2013, the Director of the Bureau Ren Xiaotie learned from the gene research of Huada University that the development of Huada’s gene sequencing business was mainly constrained by lagging regulations. On the one hand, due to the lack of industry standards, the genetic testing agencies determine the corresponding detection sites according to the self-built database, and the results of analysis and judgment are not consistent. This results in the detection reports of different testing organizations becoming very different from each other; on the other hand, genes Sequencing, as an emerging industry, lacks standardized industry standards and access mechanisms, causing confusion in the genetic testing market. He realized that gene sequencing is different from other product detection. It involves aspects such as sequencing methods, detection quality, data analysis, database management, and personnel experience. It is directly related to human health and life. Therefore, the specification of gene sequencing Management is more rigorous than management in other areas of detection, and standardization can just solve related problems. Therefore, he immediately arranged the Bureau of Standardization and the relevant experts of the Provincial Institute of Standards to the on-site instruction of Huada Gene, starting from the standardization to help solve the difficulties encountered in the marketization of scientific and technological achievements.

After more than half a year of cooperation and research, the expert group believes that standardization is an important support for promoting the standardized development of gene sequencing and testing equipment and equipment industrialization as well as going to the international market. According to the technical parameters, sequencing range and methods of Huada Gene Sequencing, the Provincial Standards Institute transformed the patented technology into standards, formulated the standard table of gene sequencing, and solved the problem of uneven standard specifications, non-standard sequencing methods and inconsistency. , to achieve the standardization of BGI’s internal technology.

It is understood that the Bureau will soon publish three local standards: "High-throughput gene sequencing technology specifications", "based on genetic sequencing of mixed meat identification methods" and "genome composition into quality assessment requirements", first of all to regulate the production of gene sequencing industry Activities to ensure the safety and effectiveness of gene sequencing technology, and promote the coordination and cooperation of related gene sequencing instruments, reagents, and services. The second is to standardize the quality inspection methods of the products obtained in the process of gene synthesis and the requirements that should be met by qualified products, and to define the basic elements that the product testing report should have, so as to establish a unified quality requirement for gene synthesis.

At present, BGI is participating in the high-throughput gene sequencing SEQC standard led by the US FDA on the basis of these three local standards to achieve global mutual recognition of gene sequencing results. At the same time, the Provincial Institute of Standards has joined Huada Gene in declaring a "Pilot Project for the Comprehensive Standardization of the Gene Industry" and a "National Standardization Technical Committee for Gene Sequencing," aiming to establish a sound industry standard system and establish a comprehensive Sequencing and testing instruments and equipment through standardized means to achieve industrial standardization development, and then master the gene sequencing, key technology of mass spectrometry, biometric data analysis and accounting, the level of human capacity of sequencing personnel, the international standard discourse right of the production and manufacture of sequencing instruments, and promote the application of life sciences in China. globalization.