In the 1950s, Watson and Crick proposed a DNA double helix structure model, marking the birth of molecular biology as an independent discipline. Since the 1970s, molecular biology has become the most dynamic frontier in the field of life science. As molecular biology theories and technical methods are continuously applied in clinical practice, they play an increasingly important role in many aspects such as disease and prevention, prediction, diagnosis, and curative effect evaluation. The extensive intersection and penetration of molecular biology and clinical medicine has produced a new discipline direction-molecular medicine; in the late 1970s, American Chinese scientist Kan, an academician of the American Academy of Sciences, and others successfully performed sickle cell anemia using liquid phase DNA molecular hybridization The genetic diagnosis of the disease marks the era of genetic diagnosis. The genetic diagnosis is based on the detection of disease genes or genes related to disease and their expression products, so early diagnosis of the disease is achieved, but due to genetic diagnosis The method is based on modern molecular biology technology and organically integrates cytology, genetics and other technologies, making genetic diagnosis more advanced, accurate and fast, thus greatly improving the specificity and sensitivity of diagnosis.
For a long time, the diagnosis of diseases is mainly based on medical history, symptoms, signs and various auxiliary examinations, such as hematology, pathology, immunology, microbiology, parasitology and even physical examination. However, the above inspection methods have their own limitations, which makes many diseases fail to be diagnosed in time and accurately, thereby delaying the opportunity for treatment. Because many surgical diseases have existed for quite some time before the symptoms, signs, and biochemical changes of patients, people have been hoping to find a technology that can occur before the disease occurs, or even before the symptoms, signs, and biochemical changes have occurred. Make a diagnosis; for some possible pathogenic factors, including food, water quality, and pathogens present in the environment, people also expect to have simple and accurate methods for timely detection. With the continuous improvement and maturity of gene diagnosis technology, its field of application and scope of application are continuously expanding, especially the advent of polymerase chain reaction (PCR) technology in the mid-1980s and the launch of the Human Genome Project in the early 1990s, which further promoted the gene Development of diagnostic technology. The development of molecular biology technology has realized the long-awaited above-mentioned desire. In November 1999, the American Society of Research Pathology and the Molecular Pathology Association published the "The Journal of Molecular Diagnostics" magazine, marking this in molecular biology. A brand new diagnostic technology established on the basis of the development of scientific theory and technology has developed into a mature discipline-molecular diagnostics.
Molecular diagnostics is based on the theory of molecular biology and uses molecular biology techniques and methods to study the existence, structure or expression regulation of endogenous or exogenous biological macromolecules and macromolecular systems in the human body for disease prevention. , Prediction, diagnosis, treatment and outcomes provide information and decision-making basis, review the development history of molecular diagnostics for more than 20 years, and roughly experienced three stages:
(1) Using DNA molecular hybridization technology for genetic diagnosis of genetic diseases;
(2) DNA diagnosis based on PCR technology, especially the application of quantitative PCR and real-time PCR, can not only detect the load of multiple DNA and RNA pathogens present in the host, but also detect the expression of mRNA in multigene genetic disease cells the amount.
(3) High-throughput intensive detection technology represented by biochip technology. Biochip technology includes gene chips, protein chips, tissue chips, etc. Due to its working principle and result processing process, it breaks through traditional detection methods. It not only has the characteristics of strong sample processing ability, wide use and high degree of automation, but also has broad and application prospects and commercial value. Therefore, it has become a hot spot in the field of molecular diagnostic technology.
The development history of molecular diagnostics has revealed its development direction:
1) The content of molecular diagnosis has evolved from traditional DNA diagnosis to comprehensive diagnosis of nucleic acids and their expression products (mRNA, protein);
2) The strategy of molecular diagnosis has evolved from the diagnosis using single techniques such as molecular hybridization and PCR to the combined diagnosis of multiple technologies combined organically;
3) The methods of molecular diagnosis have evolved from qualitative diagnosis to semi-quantitative and quantitative diagnosis, nucleic acid labeling technology, especially the development of fluorescent labeling technology, fluorescent quantitative PCR technology and other methods are increasingly mature;
4) The molecular diagnosis ranges from the diagnosis of single-gene diseases (Mendel inherited diseases, such as leukemia, premature aging, hemoglobin disease, hepatitis A virus, human immunodeficiency virus, human papilloma virus, etc.) to the diagnosis of polygenic diseases ( Diagnosis of tumors, cardiovascular and cerebrovascular diseases, metabolic diseases, nervous system diseases, autoimmune diseases, etc.);
5) Application of molecular diagnosis Multi-therapeutic diagnosis has evolved to preventive analysis and evaluation, especially for screening disease genes or disease-related genes for high-risk groups.
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