The development of molecular diagnostic technology

 Molecular diagnosis is an emerging laboratory medicine technology that applies molecular biology principles and techniques to disease diagnosis. It is based on disease-related genes and their products, and explores the mechanism of disease occurrence and development at the molecular level, and provide critical information and decision-making basis for disease prevention, diagnosis, efficacy evaluation, and prognosis.

The development of molecular diagnosis

The development of molecular diagnostic techniques began in 1953. Watson and Crick discovered the DNA double helix structure, which unveiled the mysterious veil of life and laid the foundation for molecular diagnosis. In 1963, Sanger invented the dideoxy sequencing method, which provided a direction for human to understand genetic DNA. 1972~1973, Berg et al. created recombinant DNA technology and expanded molecular diagnostic techniques. In 1976, Kan et al. applied DNA molecular hybridization technology for prenatal diagnosis of α thalassemia, which realized early diagnosis of the disease, marking the beginning of molecular diagnostic techniques for clinical testing. In 1985, the development of polymerase chain reaction (PCR) technology greatly promoted the development of molecular biology and became a milestone in the revolutionary innovation and technological development in the field of biomedicine. PCR and its derivative technology have become widely used in the field of molecular diagnostics because of its simple, rapid and adaptable operation. The high-throughput-intensive technology represented by biochip technology can carry out a large number of detection and analysis because of the large number of probes on the support, which makes up for the low degree of automation, and the detection target has few and low molecules of traditional nucleic acid hybridization. It has become a hot spot in the field of molecular biology technology, greatly promoting the development of molecular diagnostics. In 1990, the Human Genome Project was launched. By the end of the genome project in 2003, molecular biology research was entered into functional genomics research. Scientists began to explore the relationship between disease and drug resistance and target genes, making the model of medicine turned to the clinical research phase of individualized treatment. At present, molecular diagnostics account for a small share of the experimental diagnostic market, but it has grown very rapidly. It is estimated that molecular diagnostic techniques will play a leading role in experimental diagnosis in the next 10 years

Future development of molecular diagnosis

According to the "China Molecular Diagnostics Industry Analysis Report", it is estimated that by 2020, the global molecular diagnostic market will increase from 6 billion in 2015 to 9.3 billion US dollars, with a compound annual growth rate of 9.3%. The molecular diagnostic market in China has grown from 1.65 billion yuan in 2010 to 4.59 billion yuan in 2014, with a compound annual growth rate of 29.1%. The proportion of the IVD market has increased from 11% in 2010 to 15% in 2014. Above the overall growth rate of IVD, it is far more than the global molecular diagnostic market growth rate during the same period. China's molecular diagnostic market is huge and its growth rate is very fast. It is an important market for foreign medical diagnostic giants and domestic diagnostic companies.

In addition, China has policy support. According to the 13th Five-Year Plan of China in 2016, the development of molecular in vitro diagnostics is clearly proposed: to develop high-throughput low-cost gene sequencers and gene editing equipment, and to greatly improve the stability and reliability of medical equipment. Accelerate the development of new products such as in vitro diagnostic equipment and reagents, promote the development of new technologies such as high-specificity molecular diagnostics and biochips, and support rapid and accurate diagnostic screening such as tumors, genetic diseases and rare diseases. At present, molecular diagnostics are mainly used in infectious diseases, oncology, genetics, blood screening and microbiology; the main technologies include PCR, chip, hybridization, DNA sequencing and next generation sequencing (NGS). As technology matures, molecular diagnostics will be applied to more fields.

Whether in China or globally, molecular diagnostics are gaining unprecedented attention. With the support of governments and the breakthrough of related technologies, the global molecular diagnostics industry will usher in rapid development.

Edited by Suzhou Yacoo Science Co., Ltd.