Reason:
Gene sequencing related technologies and products have gradually evolved into clinical use, which brings risks of safety and effectiveness. However, the genetic testing stopped this time is mainly aimed at non-invasive prenatal genetic testing and second-generation sequencing technology, and it is not a blanket ban on all testing fields.
Emergency stop mainly involves detection categories: prenatal screening of fetal Down syndrome to diagnosis of neonatal defects (detection of neonatal hereditary diseases). That is, in genetic testing, prenatal screening of non-invasive prenatal genetic testing, that is, fetal "Down syndrome."
The emergency stop involves technology: the second generation of Qualcomm quantitative gene sequencing technology (gene sequencing technology has two generations: the first generation of single gene sequencing and the second generation of Qualcomm quantitative gene sequencing. At present, the first generation sequencing technology is the internationally recognized gold standard sequencing technology, while in China, single gene sequencing has been used for many years and is very mature)
In the same year, the General Administration of the Food and Drug Administration of the United States announced on July 2 that the second-generation gene sequencing diagnostic products, including two gene sequencers and two detection kits, were approved for the first time to screen the risks of down syndrome and other congenital genetic defects in pregnant women and avoid birth defects in newborns. After the prenatal genetic testing was suspended for half a year, only medical devices passed the examination and approval.
The emergency stop is only for the reasonable regulation of the industry.
All diseases are related to genes.
Gene is a functional fragment carrying genetic information on DNA molecules, and it is the substance that organisms transmit genetic information. Genes dominate life and are the foundation of life.
Predictive medicine. It can accurately predict the disease risk in healthy period and sub-health period.
Disease prevention. Disease = internal cause+external cause. Through the understanding of internal causes, the influence of external causes can be effectively avoided, thus reducing the risk of illness.
Health management. If you know that you have a certain disease susceptibility gene through genetic testing, you can actively improve your environment and living habits and do your own health management.
Personalized medical service. Through genetic testing, we are reminded which drugs to use with caution, which not only greatly reduces unnecessary medical expenses, improves the curative effect, but also avoids causing greater harm to the human body.