Gene sequencing-related technologies and products, gradually evolved to clinical use, bringing safety and effectiveness risks.
The stopping of genetic testing is mainly for non-invasive prenatal genetic testing and second-generation sequencing technology, not a blanket ban on all testing areas.
1.On February 9, 2014, the State Food and Drug Administration and the Office of the National Health Planning Commission released a notice on their official websites urgently calling a halt to the use of gene sequencing-related products and technologies in clinical medicine.
2. The emergency call-off mainly involves testing categories: prenatal screening for fetal Down syndrome to the diagnosis of neonatal defects, i.e., in genetic testing, non-invasive prenatal genetic testing of prenatal screening, that is, screening for fetal Down syndrome.
3. Emergency call off involving technology: second-generation high-throughput gene sequencing technology, gene sequencing technology has two generations, the first generation of single-gene sequencing and second-generation high-throughput gene sequencing.
4. At present, the first-generation sequencing technology is internationally recognized as the gold standard sequencing technology, and in the country, single-gene sequencing has been applied for many years, very mature.
:Genes are the basic unit of heredity, DNA or RNA sequences carrying genetic information, through replication, passing genetic information to the next generation, guiding the synthesis of proteins to express the genetic information they carry, thus controlling the expression of traits of biological individuals.
Genetic testing is a technology that detects DNA through blood, other body fluids, or cells. It is a method that takes peripheral venous blood or other tissue cells of the tested person, amplifies their genetic information, and then detects the DNA molecular information in the cell of the tested person through specific equipment to analyze the types of genes and gene defects it contains and whether its expression function is normal, so as to make people able to
Genetic testing can be used to diagnose disease and to predict disease risk. Disease diagnosis is the use of genetic testing technology to detect mutated genes that cause hereditary diseases. The most widely used genetic tests are the detection of hereditary diseases in newborns, the diagnosis of hereditary diseases, and the auxiliary diagnosis of certain common diseases.