It is because the industry is relatively chaotic, the national regulatory authorities to regulate the industry.
Currently, gene sequencers and related reagents and software used in clinical diagnostics in China have not been approved by the national review and approval of medical devices, and are suspected of being "illegal medical use".
As long as the use of gene sequencing methods for clinical diagnosis, all stop. In addition to laboratory research, including prenatal genetic testing, including all medical technology needs to be applied to the testing instruments, diagnostic reagents and related medical software and other products, such as for disease prevention, diagnosis, monitoring, treatment detection, health status evaluation and prediction of hereditary diseases, all through the food and drug regulatory authorities for approval and registration, and through the health planning and sanitation administrative departments to approve the technical access can be applied.
A staff member of the Maternal and Child Division of the Health and Family Planning Commission of Zhejiang Province disclosed that gene sequencing involves a series of issues such as ethics, privacy, etc., and the reason why it was halted is that the national regulatory authorities want to regulate the industry.
For example, some organizations claimed that gene sequencing can measure the "talent gene" to achieve the child's "tailor-made". What's more, in the publicity and description of some domestic medical institutions, gene sequencing technology is full of magical colors, creating an illusion of "all diseases".
Additionally, there is a lack of regulation of pricing in the gene sequencing market. Like Hangzhou, a number of physical examination centers have launched disease or cancer risk prediction project, the offer more than a few thousand yuan or even more than 100,000 yuan, gene sequencing has become a part of the eyes of the fat meat, into a violent industry.
On the other hand, limited to the current level of science and technology, the accuracy of some genetic testing is not high, many genetic testing organizations in order to achieve eye-catching effect and economic benefits, suspected of false advertising. This also leads to gene sequencing, this is a laboratory research method, into the clinical application, in many places into the laws and regulations of the "gray area", urgently need to rectify.
Extended information:
The impact of calling off gene sequencing on clinical applications:
In clinical medicine, gene sequencing is mainly used in the prenatal non-invasive screening of some pregnant women at an advanced age, as well as the examination of patients with suspected genetic disorders, and not
In clinical medicine, gene sequencing is mainly used in prenatal non-invasive screening for pregnant women at an advanced age and in the examination of patients with suspected genetic diseases, and is not a medical check-up program for "sky-high prices". However, the prenatal genetic testing has also been stopped, the victims will be the majority of patients. It will mean that many high-risk women who could have received non-invasive prenatal diagnosis now have to go to traditional testing methods such as amniocentesis.
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