Gene editing technology has entered a practical phase and the Sale of Gene Editing Kits is prohibited in the United States.

The first U.S. law to directly regulate CRISPR has stopped consumers from buying and using the kits themselves.
the global gene editing market will reach $8.1 billion by 2025.
, California recently introduced a bill against CRISPR gene-editing technology that prohibits the sale of gene-editing kits in The State unless sellers are prominently warning consumers not to use them on themselves.
this is the first law in the United States to directly regulate CRISPR.
Act, no one may sell a gene-editing kit in California unless permitted by federal law, unless the seller puts a clearly visible label on its website and the kit's packaging stating that the kit cannot be used for self-use.
the bill will come into effect in January 2020.
the use of biological hackers to bring security risks" personal use, whether research or application, will be due to lack of expert reminders, norms and supervision, easy to be subject to personal self-control, social responsibility, operational level and cognitive restrictions, and inevitably go astray, the emergence of unpredictable consequences.
" Jiang Qi, a senior engineer at the Biological Research Center of the Institute of Genetics and Development of the Chinese Academy of Sciences, told Science and Technology Daily.
2017, the U.S. Food and Drug Administration (FDA) said it was illegal to sell gene therapy products for self-use because they had not yet been approved. the use of
CRISPR technology is also regulated by the European Union.
California's CRISPR act focuses on the use of CRISPR technology by amateurs.
the bill mentions that there are some materials on the market that can be tested and sold under the name "self-use".
this phenomenon raises concerns about consumer safety, public health and what amateurs will create using CRISPR technology.
the bill says its intent is to keep consumers and the public safe without stifling innovation.
There is a specific reason for California's legislation, according to the Massachusetts Tech Review.
the bill directly targeted a California resident named Josiah Zaina, who is also a biohacker.
2017, Zaina gained notoriety for filming and posting on the Internet that he injected CRISPR into his arm.
he told the MIT Technology Review that he is selling a CRISPR product online that encodes a protein gene called myotropin, which can make muscles stronger by removing it.
the necessary link of the operation requires that the individual can not do "the gene editing tool box has two main components, the first can cut off the double-stranded DNA, that is, the gene's chemical carrier of the protease molecule Cas9, the second is used to guide Cas9 in the DNA accurately cut the site of a sgRNA sequence.
," Jiang said.
several biotechnology companies in China are already selling their imitations.
", "This kit is relatively inexpensive, a genetic modification operation consumes the cost of this kit in about 100 yuan, with undergraduate biology or medical background training people can basically operate.
," Mr Jiang said.
but Zaina's DIY approach of injecting genome editing kit ingredients directly into him lacks basic scientific norms.
Jiang Yu believes that this is a mess, of course, it is basically impossible to bring any effective gene editing results, but there is a risk of inflamed mouth, is not a scientific approach. jiang
introduced, the standard gene editing, even the simplest of the transformation of the cell line, but also need to design and synthesize sgRNA, cell culture, cell transformation, variant screening and identification process;
in addition to the specification of the use of kits, there are many necessary operating conditions and more complex cell operation techniques, is not a person can do.
bill states that because CRISPR technology is still in its infancy, especially in the public consumption sector, more research is needed to ensure the safety of these products.
, consumers should be aware that any CRISPR-related gene therapy product is not suitable for self-use.
gene editing regulation was not the original purpose of a blank gene-editing technique, but was designed to combat other diseases that were difficult to find, such as thalassemia, caused by a genetic mutation in thalassemia.
its initial heart is to cure the disease, not to transform people, so we must abide by the rules of scientific research, to adhere to the ethical bottom line.
from an academic point of view, there are two main directions of intervention of gene editing.
" is a disease caused by congenital genetic defects that are not currently available for treatment in humans without normal medical treatment, and there is no obvious controversy in the direction of this research by altering the adjustment of human genes to achieve therapeutic purposes through gene editing.
another is preventive gene editing, which eliminates the possibility of future illness by geneticed editing of embryos.
the current research direction there is a relatively large controversy, the main controversy lies in the medical method of the argument is not sufficient, in comparison with the drug means, necessity argument and genetic change rationality argument, etc. , still need to continue to supplement and improve the evidence.
" Jiang Yu introduced.
", "In fact, gene editing does not have regulatory gaps, the scientific community of gene editing research behavior by peers to remind, regulate and supervise."
," Mr Jiang said.
for example, in 2015, the National Academy of Sciences and the School of Medicine proposed gene-editing guidelines for human embryos and reproductive cell cells, and the Human Gene Editing Summit, jointly organized by the National Academy of Sciences, the National Academy of Medicine, the Royal Society, and others, held the first time in the United States to explore the scientific, ethical and social issues related to human gene editing technology and to agree on the regulation of gene editing for somatic and reproductive cells.
and the application of gene editing technology in human sushes is regulated by the relevant norms of gene therapy.
"SFDA released in 2017 self-management information on gene therapy, arguing that the use of CRISPR gene editing in humans is a gene therapy and subject to regulatory oversight by the FDA's Bioproduct evaluation and research center.
," Jiang said. Jiang,
, believes that if one day the technology is widely used, it must be because it is necessary to use for the treatment of genetic diseases that cannot be cured by human medical treatment, which is also the general consensus of the global scientific community.
extended reading gene editing technology has entered the practical stage", there are more than 6,000 mutant single genes in human genes that cause certain birth defects that cannot be prevented by existing medical methods, which requires the intervention of gene editing techniques.
," Mr Jiang said.
CRISPR is a versatile gene-editing technique that largely advances gene therapy.
the bill mentions that CRISPR technology has significantly improved its ease of use, effectiveness and cost compared to other gene-editing techniques;
there are important studies in the use of CRISPR to treat diseases such as diabetes, malaria and sickle cell disease.
" gene editing technology has long been in practical phase.
the lowest-cost and simplest third-generation gene editing technology, CRISPR, is the fastest growing.
," Jiang said.
California is at the forefront of gene editing research, with Dudner, the co-inventor of the widely used CRISPR technology, from the University of California, Berkeley. the market value created by the
gene editing industry comes mainly from cell line modification, as well as genetic engineering, gene diagnosis and treatment, gene editing of plants and animals and other applications. "The efficiency of gene editing technology needs to be further stabilized and improved, and relevant data are needed to conduct reasonable medical evidence, and there is still a long way to go before it can be proved,"
.
the United States is leading the way in the development of gene editing core technology upgrades, and China is at the forefront of the world in plants, especially crops and medical applications.
," Jiang stressed.
Source: Science Daily.