The era of molecular diagnosis is coming to China to solve the five major problems

First, the detection subject is not clear

For a long time, the departments of clinical molecular diagnostics projects in China have mainly been the medical laboratory inspection departments that have been reviewed by the clinical inspection center, and basically have established a relatively complete laboratory quality management system. Inspectors generally undergo standardized training and have a good awareness of the quality of molecular diagnostics related testing operations. In recent years, individualized precision medicine, which is characterized by individualized treatment, is moving to the forefront of clinical medicine, bringing concepts such as "pharmacogenomics" and "molecular pathology". Therefore, in recent years, relevant individualized medical tests have been carried out in the pharmacy, pathology, oncology, obstetrics and gynecology, ophthalmology, and even central laboratories of many medical institutions across the country. The situation and the detection of pathogen nucleic acid PCR in the early 1990s similar.

Second, the employees are not up to standard

At present, China is a blank in genetic diagnosis and ethical review related to molecular diagnosis, genetic counseling training is lagging behind, and lack of clinical consulting experience. In addition, there are ethical issues that have long neglected genetic testing, including privacy protection of patients' genetic information, clinical interpretation of molecular diagnostic reports, and counseling. Due to the high requirements for molecular diagnostics for specimen collection, processing and quality inspection, specimen collection personnel should be well trained. In addition to the skilled testing operation skills, laboratory testing operators must also have basic knowledge reserves related to the corresponding clinical applications. For example, the relationship between individualized drug treatment testing programs and the clinical application of the corresponding drugs.

The testing physician needs to keep track of the latest clinical scientific research progress, analyze the relationship between the actual treatment effect of the clinical case and the test result, and have the ability to communicate with the clinician and propose further test recommendations and provide corresponding treatment advice according to the patient's condition. At present, the quality of practitioners in many clinical laboratories cannot meet the needs of the molecular testing projects carried out. In addition, the lack of testing physicians in clinical communication, the ability of the testing laboratory and clinicians to communicate according to the molecular diagnostic report is weak, causing the clinician to ignore the molecular diagnosis. At present, with the wide application of second-generation sequencing technology in clinical practice, the professional analysts who conduct big data analysis for clinical test results are not obvious.

Third, quality supervision is not in place

Due to the diverse and complex molecular diagnostic methods and the fact that domestic testing institutions are more manual, it is not easy to establish a unified and standardized quality supervision system. The quality control of some projects in the laboratory for molecular diagnosis was carried out spontaneously by the laboratory, lacking indoor quality control, inter-room comparison and industry supervision; some projects did not perform capability verification at all. Other laboratories do not participate in quality control projects. This situation directly affects the reliability and credibility of the results of molecular testing projects, and is one of the reasons why molecular testing reports are not clinically important. At present, although the Health and Family Planning Commission has also carried out some quality control of sequencing project testing, the participating units are all voluntarily conscious, and there is no rectification and corrective measures for the units that do not participate or the units that participate but are not qualified.

It is recommended to establish a national unified molecular diagnostic quality control system based on the current actual situation, formulate detailed quality control standards and continuous improvement measures for molecular testing projects, and develop in vitro diagnostic devices (IVD) and LTDs that have been approved by the administrative department. The two lines of supervision are organized and implemented by the health administrative department, the quality control center and the regional inspection center. Considering the special nature of the rapid development of molecular testing projects, it is necessary to update and timely update the standard substance preparation, capability verification and quality control evaluation of molecular testing projects to avoid long-term supervision gaps.

Fourth, the LDT project is underdeveloped

Limited by China's existing inspection project registration and approval system and fee management system, the LDT developed by clinical medical laboratory is far from the developed countries in terms of quantity and type, and cannot meet the individualized growth of clinical diagnosis and treatment. Accurate demand. It is recommended that pilot units be used in combination with appropriate quality control.

On the one hand, the national clinical key inspection specialist construction unit, the inspection department of the top three hospitals approved by ISO 15189 or CAP will be partially released, and the medical inspection department of large-scale hospitals will gradually liberalize and even encourage the appropriate development of LDT projects.

On the other hand, the implementation of appropriate quality supervision, the so-called appropriate is to fully consider the current reality of domestic LDT development, if the "sprout" state of the LDT reference to the United States trial too strict, excessive supervision, may greatly hinder medical testing The application and development of new methods and technologies in the laboratory. On the basis of summarizing the experience of the LDT pilot units in a timely manner, we can create conditions for the scientific and rational use of LDT in a larger scope. Scientific and rational supervision in the development of innovation should become a new idea and new model of LDT regulation in China.

5. The charging standards and medical insurance policies lag behind

The National Health and Family Planning Commission has issued the Catalogue of Clinical Laboratory Projects for Medical Institutions (2013 Edition) and the Nonprofit Medical Services Project (2013 Edition), which contain relatively complete molecular diagnostic charges, and the provinces have also promulgated or are Intensified development and promulgation of their own charging standards, but the development of project charging standards is lagging behind the development of molecular diagnostic technology. Many projects, such as the relatively rapid development of second-generation sequencing projects, also need to borrow from a generation of sequencing projects, even for a generation of sequencing projects. The regulations are not reasonable, they are more general, and it is not convenient for clinical implementation. For example, in Shanghai, only one generation of sequencing dideoxy chain end-sequencing sequencing method 600 yuan/sequencing reaction was clarified, and there is no clear specific description for other types of sequencing technology charging regulations. Secondly, even if there are clear and clear charging standards, the medical insurance department has not yet responded, which leads to the restriction of testing costs, and also affects and limits the healthy development of current molecular diagnostic applications.

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