918博天堂

Following the "Human Genome Project", in January 2015, US President Barack Obama announced the US "Precision Medicine Program", which is based on the accurate collection of individualized big data information and analysis, the establishment of individualized data and specific disease types and The relationship between the state of progress, so as to accurately find the cause and implement targeted personalized treatment, in order to achieve the best therapeutic effect. At the International Symposium on "Development and Quality Control of Proteins and Peptide Drugs and Diagnostic Reagents" held on June 1st to 3rd, experts from the National Institute of Standards and Technology (NIST) attracted reports on precision medicine. A lot of listeners.

    Accurate medical planning is an important measure to significantly improve the effectiveness and level of national health care. The concept of precision medicine originated from the "precision weapon", and its core is "precision." Dr. John Schiller of the NIST Biochemistry Analytical Science Working Group told reporters that the implementation of precision medicine relies on accurate measurements, and that the premise is that there are accurate "rules" or "weights". The measurement provides various measurement and accuracy measurement standards for various types of measurements as “ruler” and “weight” to ensure accurate and effective measurement results. According to statistics, 80% of doctor's diagnosis results from clinical test results, if the cholesterol detection deviation is reduced by 3%, the clinical diagnosis false negative rate will be reduced by 9%-20%; if the tumor marker detection deviation is reduced by 10%, false negative The rate will be reduced by 10%-50%, so the accuracy of the test results will be improved by the use of measurement standards, which will greatly improve the reliability of the diagnosis. It can be said that measurement is the key to achieving precision medicine.

    Dr. John Schell, an example of accurate analysis of individualized data such as genomes and proteomics, told reporters: “NIST has supported research on the requirements of these omics measurement standards as a priority area for priority development, which has been in existence for 10 years. Continue to support during the time, from research projects, research funding, researchers and research equipment, etc., and continue to increase investment. In the next five years, it is still necessary to strengthen research on measurement science and standards, and promote the concept of precision medicine. To increase confidence in medical decision-making."

    It is understood that from 2009, the US NIST only invested 5 million US dollars in research on proteomics and genome measurement standards. At present, a number of high-accuracy measurement methods such as organic biochemistry and biological macromolecules have been established; research on in vitro diagnostic measurement standards has been carried out, and a series of in vitro diagnostic reference materials such as cardiac troponin I have been developed to ensure the accuracy and reliability of clinical test results. The developed reference material provides traceability technical services for the production of diagnostic kits for US companies, ensuring a US share of approximately 4.2 billion euros in the EU euro market.

    In recent years, Dr. John Sil is mainly engaged in the research of therapeutic monoclonal antibody drug characterization methods and standard substance development projects. He told reporters that the therapeutic monoclonal antibody project is a key work initiated by NIST in recent years. Therapeutic monoclonal antibodies are mainly used in the treatment of cancer, autoimmune and inflammatory diseases, and organ transplantation resistance. Because therapeutic monoclonal antibodies have target specificity, they have broad applications in individualized symptomatic treatment. prospect.

    “NIST has developed a detailed research plan for the development of therapeutic monoclonal antibody drugs. The plan is divided into three steps. First, research on monoclonal antibody characterization technology, development of new characterization techniques, and comprehensive characterization of antibodies using as many methods as possible. Various properties; then develop monoclonal antibody reference materials to form a reference database; finally try to promote and apply in biopharmaceutical enterprises. After the above steps, the results of therapeutic monoclonal antibody drug characterization are more accurate and reliable, which can significantly shorten the development of new drugs. The cycle can reduce the cost of new drug development and drive the improvement of the quality of biomedical products, which will help to enhance the competitiveness of the entire bio-industry.” Dr. John Siler proudly said: “NIST has developed RM 8671 therapeutic Monoclonal antibody reference materials can be used for the development of characterization methods and quality control of related products."

    In recent years, the China Institute of Metrology has also actively carried out research on measurement standards for precision medicine and is actively engaged in international cooperation. In 2015, the institute signed a “Cooperation Agreement on Standards for Greenhouse Gas Measurement and Precision Medicine” with NIST, and was also included in the list of President Xi Jinping’s visit to the United States. This is one of the contents of the strategic cooperation framework agreement between the Chinese and US governments.

    According to Li Hongmei, the director of the Institute of Chemometrics and Analytical Science of the China Institute of Metrology, the cooperation between China and the United States will complement each other, share technology and data, verify mutual international equivalence, and form a group of internationally recognized and comprehensive support. The mutual recognition ability of measurement standards in the field of precision medicine achieves the goal of mutual benefit. At the same time, it will break through a number of high-accuracy macromolecular characterization techniques, establish a number of internationally recognized reference methods and standard databases, and develop a number of internationally advanced in vitro diagnostic and biomedical reference materials to enhance product quality and efficiency. The equality and mutual recognition of biomedical products between the two countries will reduce trade technical barriers and enhance the international competitiveness of the industry. In addition, it will also cultivate a high-quality precision medical measurement standard talent team and an international advanced level measurement technology system, and build a technology platform for production, learning, research and use. It can not only provide internationally recognized measurement technology and measurement “ruler” for China's precision medical bio-industry, but also reduce re-testing and mis-testing, avoid resource waste and medical burden, and protect public health.  (Source: China Metrology Network)