In recent years, the concept of precision medicine has been favored by capital in the medical field, and more and more capital and enterprises have entered the field for development. At the market level, the scale of the entire precision medical market is expanding at an ever-increasing rate. At the technical and academic level, precision medicine is also on the road from individual hotspot detection of single genes to multi-gene, whole-genome-wide platforms.
According to the "2018-2023 Global Precision Medical Market Outlook Survey and Investment Opportunity Research Report" published by the China Business Research Institute, from 2016 to 2020, the global precision medical market will grow at a rate of 15% per year, and is expected to be 2020. The global precision medical market will break through 100 billion, reaching $105 billion.
In March 2016, Precision Medicine first entered the CPPCC proposal, and Yang Jinsheng, a member of the National Committee of the Chinese People's Political Consultative Conference, recommended precise prevention and treatment of cancer. According to the "2017-2021 China Genetic Testing Industry Investment Analysis and Prospect Forecast Report", in China, genetic testing is developing rapidly with the advancement of technical means. In 2017, it was also praised by many experts and scholars in the medical field. For the year of China's precision medical care, CFDA's approval rate for new drugs and devices is gradually increasing. However, from the current development status of domestic companies, although the number of mainstream listed companies using high-tech NGS detection technology is only Huada, Berry and Kang, the number is very small, but in the field of precision medical treatment of cancer, there is no The scale and mainstream influence of any domestic enterprise.
At the same time, the two genetic testing and analysis platforms approved by the FDA at the end of 2017 have had a huge impact on the entire precision medical treatment. On November 15, 2017, the US FDA officially approved MSK-IMPACT, a cancer genetic detection and analysis platform commemorating the Skelon Lynn Cancer Research Center (MSK), for 468 genetic tests for cancer patients, which is a more comprehensive cancer sequencing. The platform can identify a greater number of genetic mutations (biomarkers) in a variety of cancers.
Two weeks later, on November 30, the FDA and the Centers for Medicare and Medicaid Services (CMS) approved Foundation Medicine's product, FoundationOne CDx (F1CDx), for the clinical diagnosis of pan-cancerous cancer, including 315 genetic variants. Detection, this is the first breakthrough NGS-based in vitro companion diagnostic product.
The above two approvals are the first time that the FDA does not target a specific site of a specific gene, but is based on the entire panel of hundreds of cancer genetic tests and the corresponding technology platform for approval. It is an important leap in the development of precision medicine.
In this regard, Yiou Health interviewed Dr. Wang Kai, the founder of Zhizhi Medical Technology . As early as 2001, Dr. Wang Kai started a generation of sequencing work at Huada Gene, and then went abroad to study. After leaving Harvard University in 2011, he participated in cancer. The founding of Foundation Medicine, the leading company in the sequencing industry. During the five-year period of his work, he participated in the launch of all clinical products, process validation, personnel training, and clinical annotations. He began to participate in the FDA communication process, experimentation, and verification in the accompanying diagnostic department, and helped the F1CDx to be approved. jobs. Regarding the two FDA approval actions, Dr. Wang Kai also shared his views with Yiou Health.
The development trend of precision medicine - from single gene to multi-gene detection
"This FDA approval for the entire precision medical industry has finally broken through the detection of multiple gene platforms by traditionally detecting individual sites of individual genes."
Specifically, MSK-IMPACT is an NGS panel-based hybrid capture technology that rapidly detects all protein-coding mutations, copy number variations, partial promoter mutations, and structural rearrangements on 468 unique genes associated with cancer. As is routinely tested, MSK-IMPACT is suitable for any tumor type.
It is understood that researchers have used MSK-IMPACT to sequence more than 20,000 MSH patients with solid tumors. The key research idea is to use normal tissues to match tumor tissues to compile somatic mutation catalogues of various tumors. So a database is generated. This database contains DNA sequences, related pathology and clinical annotation data for cancerous and normal tissues of patients with advanced cancer. The database is important for identifying new biomarkers and predicting subsequent treatment responses.
At the same time, F1CDx is approved by the FDA for clinical concomitant diagnosis of five solid tumors, covering various variants of 324 cancer genes, and simultaneously detecting two important indicators of immunotherapy for MSI and TMB. With an overall accuracy of 94.6%, F1CDx has a truly revolutionary milestone in the field of in vitro diagnostics for any solid tumor.
Dr. Wang Kai told Yiou Health, although from the time point of view, the approval for MSK is more advanced, but in terms of actual clinical significance, the latter is actually more clinical and commercial value. Dr. Wang Kai said that the clinical evidence for MSK is not much in the process of approval, and F1CDx is approved as a clinical companion diagnostic method under more stringent conditions and based on clinical data of a certain scale. In the application of drugs, clinical guidance, commercial insurance, etc., the depth of commercialization is even better. This is the victory and reward of the cooperation between many colleagues of Foundation Medicine and the FDA. It is also a great win-win situation for the whole industry.
It is easy to find definitions for companion diagnostics on the Internet, mainly to provide information on the treatment response of patients for specific treatments, often through a “one-on-one†model to help doctors diagnose any solid tumor patient, this time. The approved F1CDx is beyond the "one-to-one" mode.
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