Prenatal gene sequencing projects have not been approved

According to China Voices National News Network, the National Food and Drug Administration and the Health and Family Planning Commission had previously issued a notice that any medical institution must not carry out clinical applications of gene sequencing before relevant access standards and management regulations are issued. The State Food and Drug Administration has made it clear today that prenatal gene sequencing projects, including Down's syndrome and congenital deafness, have not been approved.

Gene sequencing, especially prenatal gene detection, has been used in our country for a long time. As the most widely known antenatal genetic testing program, Down's screening requires only 5 ml of blood from a pregnant woman to calculate the risk of Down's syndrome in the fetus. After the technology was halted by the regulatory authorities, Huang Shangzhi, director of the WHO Community Center for Control of Genetic Disorders and Cooperation, expressed strong concern that he believes that single-gene detection like Down's screening and "one drop of blood is a common disease." Whole-genomic testing should be treated differently.

Huang Shangzhi: One type is called generation sequencing, one type is called second generation sequencing, second generation can do simultaneous detection of many and many genes, and one generation is targeted to detect one fragment and one fragment. Now it is not clear which technology is called for gene detection. It has been more than ten years and twenty years since the first generation of prenatal diagnosis in our clinical applications.

In response, Gao Guozheng, deputy director of the Department of Medical Device Registration of the State Food and Drug Administration, publicly responded for the first time that the gene sequencing was stopped because its registration was not in place.

Gao Guosheng: We have not mentioned the "second generation". Many of our products are now unregistered but have been used clinically and have been stopped as a product. Prenatal screening, including Down Syndrome and congenital deafness, has not been approved.

Gao Guojun also made it clear that the regulatory authorities did not close the door to "approval."

Gao Guoyu: The product itself, if the clinical and evaluation results confirm adaptation, approval is no problem. The whole field of gene sequencing involves many things, not just the clinical screening of a certain condition. For example, I predict how this person will be in the future. This matter is relatively large.