Two ministries call for gene sequencing

Recently, the General Administration of Food and Drug Supervision and the National Health and Family Planning Commission jointly issued a notice to stop gene sequencing. According to regulations, currently used genetic testing instruments, diagnostic reagents, and related medical software must be approved by the food and drug regulatory authorities for registration. Approved by the health and family planning administrative department to apply for technical access. Those that have already been carried out must stop immediately.

While regulating the industry, pre-natal non-invasive genetic testing without the “Enrollment Card” may also be in trouble.

Prenatal Down's non-invasive genetic testing is in trouble

Gene sequencing is a novel gene detection technology that enables analysis of whole genome sequences from blood. At present, gene sequencing-related products and technologies have moved from laboratory research to clinical use to detect the probability and risk of certain diseases, so as to achieve prevention or early treatment. Previously, Angelina Jolie, the international movie star, decided to carry her genetic defect gene through genetic testing and made a decision to remove the bilateral breasts to reduce the risk of cancer.

For the two ministries and commissions of this provision, a translation of a network of academic papers, the stoppage is mainly targeted at the second generation gene sequencing platform, and more refers to the prenatal Down's non-invasive genetic testing, that is, the gene, Beryllium, Kang and Daan genes and Annota and other companies' gene sequencing platforms, mainstream second-generation gene sequencing platforms include the HisSeq series produced by Illumina, the Proton platform produced by LifeTech, and the sequencing platform of CG. Because the time for the second-generation gene sequencing platform is relatively short and has not yet been reported, it is indeed an unlicensed operation.

This statement was also confirmed by Xu Jianfeng, director of the Center for Genetic Transformation and Health Intervention at the School of Public Health of Fudan University and director of the Fudan-VARI Genetic Epidemiology Center. According to Xinmin Weekly, Xu Jianfeng said that gene sequencing is only one type of genetic testing. According to his understanding, the “stopping order” is mainly aimed at second-generation gene sequencing, especially for pregnant women The detection of fetal Down syndrome is representative. "The first generation of genetic testing has been relatively mature, and many of these technologies have become the gold standard. It is worth deliberating that one should stop."

However, even the "prohibition order" that specifically targets second-generation gene sequencing has been controversial.

According to the "Beijing News" report, at present, gene sequencing has been widely used in the diagnosis of Down's syndrome in pregnant women before pregnancy.

It is reported that over the past three years, more than 150,000 Chinese pregnant women have received the test.

Down's syndrome, 21-trisomy syndrome, also known as congenital mortise or Down syndrome, is caused by chromosomal abnormalities (more than one chromosome 21). Children born with Down syndrome will face significant mental retardation, special appearance, growth and development disorders and multiple malformations.

Normal pregnant women are required to undergo screening at the time of birth. If the screening results show that the risk of Down's syndrome is higher in the fetus, further confirmation tests should be conducted to calculate the risk factors for congenital defects. According to a manager of a genetics department at a biotech company in Beijing, compared with traditional techniques, the accuracy of gene sequencing is tens of percentage points higher than traditional serum tests and can reach 99% or more.

According to the "Economic Information Daily" report, Guangxi Women's Hospital Chen Shaoke said that once halted, it means that many high-risk maternal women can accept non-invasive prenatal diagnosis, and now have to accept amniocentesis, umbilical cord blood and other detection methods. "The detection of umbilical cord blood should be done after 7 months of maternal age. Even if fetal malformation is detected at that time, it is too late."

The amniocentesis will have a certain risk of miscarriage. In recent years, there have been reports in the literature that it leads to an abortion rate of 1/1600.

Expecting industry access standards

According to the aforementioned "Economic Information Daily" report, relevant officials of the General Administration of Food and Drugs said that the halting of gene sequencing is to regulate the national market order and clinical application of gene sequencing products and technologies. Regarding this paper ban, the State Food and Drug Administration did not set a deadline for the lifting of the paper. It only required “applying for approval and application.”

In fact, as a new emerging industry, gene sequencing lacks standardized industry standards and access mechanisms, and there are many problems with relevant commercial organizations, such as the sky-high price, excessive exaggeration of their functions, and so on.

According to the “New Express” report, taking Guangzhou as an example, only a few large hospitals currently have relevant national qualifications to carry out gene detection technologies. However, this technology is also involved in high-end medical examinations and prenatal diagnosis. It has become a profitable tool for some hospitals and commercial organizations. The fees are as high as nearly 10,000 yuan, and as low as several hundred yuan.

“At present, domestic genetic testing projects have not been included in the scope of clinical testing, so there is no fee standard, as long as the prices can be reported by the price department, and sometimes the price of the same test can be as much as a few thousand dollars.” A top three hospital experts in the city According to reporters, the current status of genetic testing is confusing. In addition, those who do not have the qualification for genetic testing are also involved. The accuracy of the test results is doubtful.

In addition, many genetic testing companies have also promoted the technology as a high-end medical examination to predict the risk of various malignancies. "As long as you have a drop of blood, or even a bit of saliva, you may be able to predict the diseases that you may encounter in your life and prevent them..." Blowing genetic tests out of breath.

According to the aforementioned "Xinmin Weekly" report, Fu Hua, director of the Institute of Health Communication at the School of Public Health at Fudan University, affirmed the practice of the two ministries in regulating gene sequencing. At the same time, he said that he was more expectant about the current "one size fits all" approach. The introduction of standards and management norms, and, "In the development of these standards, we must be objective and independent, remove the impact of commercial interests."

Author: Chen Lingling

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