In recent years, the development of molecular diagnostics has encountered unprecedented opportunities, coupled with the formulation and inclination of relevant national policies, it has made it flourish. Molecular diagnosis can play a certain role in the occurrence, development, prognosis and other stages of the disease due to its rapid, sensitive and accurate characteristics, which makes it widely recognized in the medical industry.

Overview of Molecular Diagnosis and Molecular Diagnosis Automation

Molecular diagnosis is an emerging test that applies molecular biology techniques and methods to obtain the level of changes in the structure or expression regulation of human biological macromolecules and their systems, and provides information and decision-making basis for disease prevention, prediction, diagnosis, treatment and prognosis judgment Medical subdisciplines [1, 2, 3].

Since the 1970s, research in the field of molecular diagnostics has sprung up and in the ascendant, and has quickly become one of the most important fields of in vitro diagnostics. It is the most technically demanding, fastest growing, and most challenging branch in the field of in vitro diagnostics[4] . The development history of molecular diagnosis can be divided into four major stages: In 1978, Jianyuewei and others successfully performed the genetic diagnosis of sickle cell anemia using liquid-phase DNA molecular hybridization, marking the birth of molecular diagnosis; by 1985, Dr. Kary Mullis invented PCR Technology marks the second stage of molecular diagnosis; in 1992, Affymetrix of the United States produced the first gene chip, marking the entry of molecular diagnosis into the biochip stage; in 2005, 454 Life sciences launched sequencing based on the pyrosequencing method The system has created a precedent for the second-generation sequencing technology, molecular diagnostics has entered a high-throughput era of precise detection, and its application scope has been further expanded.

The development history of domestic molecular diagnostic technology still follows the general direction of molecular diagnostics development in the world. It can be roughly divided into the budding stage based on PCR technology, the development stage based on real-time fluorescent quantitative PCR technology and chip technology, and the development stage based on high throughput. The three stages of the golden age based on technologies such as sequencing, droplet digital PCR and liquid biopsy [5]. Conventional body fluid specimens are gradually being given new content. The development of genetic information carriers such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA), and exosomes (exosome) is changing day by day, which is full of endless reveries. [6].

Molecular diagnostic automation is a fully automated integrated molecular diagnostic system, which mainly includes sample collection, sample processing (cell concentration, cell disruption), nucleic acid extraction (DNA/RNA separation, etc.), gene amplification, product detection (real-time fluorescence quantification, nucleic acid Hybridization, etc.) and other detection processes. Because the sample pretreatment process in molecular diagnosis is complicated, and precise temperature control system is often required, which is difficult to realize manually, molecular diagnosis automation system came into being. It has attracted much attention for its advantages such as large flux, good repeatability, high efficiency, closed system to prevent pollution, accurate temperature control and complex pretreatment process, and not harsh on the experimental site.