Galaxy Securities lasted more than two months, and carried out an in-depth and comprehensive analysis of the policy environment of the genetic sequencing industry, technology trends and business models and investment logic of the industry giants, and released the development trend and business model of gene sequencing - exploring precision medicine An in-depth research report on (1) of the series report.

　 The government encourages the development of genetic sequencing, and the supporting certification system needs to be established.

â–  Gene sequencing related policies are frequent, clinical products are subject to government pilot and supervision

Policy Dongfeng frequently regulates the gene sequencing industry, and clinical products are regulated by the pilot license of the Health Planning Commission and the Food and Drug Administration. Before 2014, China did not have any policy provisions on gene sequencing products. At the beginning of 2014, after cFDA classified the sequencing products into the third category of medical devices, all the gene sequencing products were quickly stopped. Subsequently, cFDA and the Health Planning Commission gradually standardized the market for genetic testing products, and in June and November of the same year approved the listing of NIPT products of Huada Gene and Daan Gene. And before April 2015, the pilot licenses for genetic disease diagnosis, prenatal screening and diagnosis, preimplantation embryo genetics and tumor diagnosis high-throughput sequencing were successively issued, and then the gene detection of individualized tumors was issued in July 2015. Technical guidelines for technology, drug-metabolizing enzymes, and drug-targeted gene detection mean that precision medicine based on gene sequencing is expected to make substantial progress. Following the cFDA and the Health Planning Commission issued a supportive policy, the National Development and Reform Commission also guided the development of genetic sequencing in China.

Table 10. China's gene sequencing related policies

â–  The supporting supervision and certification system for consumer-grade sequencing products in China needs to be established

Consumer-grade sequencing products are instructed by doctors to design treatment plans rather than clinical applications, so they are not regulated by the Health Planning Commission and the Food and Drug Administration. However, due to the lack of effective supervision, the field is mixed, and the experimental methods, interpretation methods and results are not effectively constrained. It is difficult for consumers to know the accuracy of the test results of different companies and the rationality of prices. China urgently needs to establish a regulatory and certification system for such sequencing products.

The US gene sequencing industry is jointly regulated by the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Federal Trade Commission (FTC). CMS mainly regulates consumer and scientific applications through the Clinical Laboratory Improvement Act Amendment (CLIA), the FDA is responsible for the approval of clinical grade products, and the FTC is responsible for overseeing misleading and misleading product promotions.

Figure 26. US Department of Regulation of the Gene Sequencing Industry

Third-party medical laboratories are an important part of the US healthcare system, and it is reported that nearly half of clinical samples are completed in third-party laboratories each year. At the same time, nearly 80% of laboratories in the United States have passed the CLIA certification, which means that the accuracy, reliability and timeliness of these clinical laboratory test results will be recognized by CLIA, paving the way for more clinical trial projects. It also means that CLIA Labs can quickly develop a Laboratory Developed Test based on the actual needs of the market and provide reliable clinical guidance through clinical application. Since the CLIA certification was implemented in 1992, a total of 232,000 laboratories in the United States have obtained this qualification. Some new and innovative technologies are used to serve the clinic through such laboratories. In China, only a company of WuXi PharmaTech has obtained the US CLIA certification.

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