Why was genetic testing once stopped urgently?

Gene sequencing related technologies and products have gradually evolved into clinical use, which brings risks of safety and effectiveness.

The genetic testing stopped this time is mainly aimed at non-invasive prenatal genetic testing and second-generation sequencing technology, and not all testing fields are completely banned across the board.

1.2065438+On February 9, 2004, China Food and Drug Administration and the General Office of the State Health Planning Commission issued a notice in official website to urgently stop the use of gene sequencing related products and technologies in clinical medicine.

2. Emergency stop mainly involves the detection category: prenatal screening of fetal Down syndrome to diagnose neonatal defects, that is, prenatal screening of non-invasive prenatal genetic testing, that is, prenatal screening of fetal Down syndrome.

3. Technologies involved in emergency stop: the second generation Qualcomm quantitative gene sequencing technology has two generations, the first generation single gene sequencing and the second generation Qualcomm quantitative gene sequencing.

4. 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.

Gene is the basic unit of heredity, which carries the DNA or RNA sequence of genetic information. By copying, the genetic information will be passed on to the next generation, and the synthesis of protein will be guided to express the genetic information it carries, thus controlling the personality expression of biological individuals.

Genetic testing is a technique to detect DNA through blood, other body fluids or cells. It is a method to take the peripheral venous blood or other tissue cells of the subject, amplify their genetic information, and then detect the DNA molecular information in the cells of the subject through special equipment, and analyze whether the gene type, gene defect and expression function are normal, so as to make people know their own genetic information, clarify the cause or predict the risk of a certain disease.

Genetic testing can be used to diagnose diseases and predict the risk of diseases. Disease diagnosis is the use of gene detection technology to detect mutant genes that cause hereditary diseases. At present, the most widely used genetic testing is the detection of neonatal hereditary diseases, the diagnosis of hereditary diseases and the auxiliary diagnosis of some common diseases.