Overseas gene sequencing is hailed as the best technology for assessing currently known genetic diseases, and will also be an important development direction of global in vitro diagnostic technology. The technology only needs to collect a few milliliters of blood or saliva from the tester to predict the risk of cancer, leukemia and other diseases.
Gene sequencing becomes a new favorite
“In the past 30 years, the JPMorgan's medical industry summit has always been an absolute protagonist in traditional medicine companies. Biotechnology companies are only looking to see what can help.†According to the Orient Securities Research Report, January 16, 2014 This meeting of the day seems a little different. Investment bigwigs have turned to companies related to next-generation gene sequencing (NGS) technologies such as data analysis and digital medical.
The first beneficiaries of NGS are drug companies, especially drug companies for cancer drugs. In the past, lesions were used to define cancers, such as lung cancer, breast cancer, and prostate cancer. Nowadays, more and more studies have shown that the genetic path and mutations that cause lesions should be used. The lesioned body parts are only “byproductsâ€. Many first-line treatments are not only ineffective, but can even cause side effects. With the development of NGS, the efficiency of R&D projects for pharmaceutical companies will greatly increase in the future, and patients will also pay less for drugs.
In the United States, in 2000, Craig Venter, who was also selected as a ancestor of the time magazine and at the same time as the representative of the Human Genome Project, was re-launched in March 2014 to establish Human Trendev Inc., raising $70 million in the first round. Investors included the world's largest gene. Test equipment provider Illumina. "With Illumina's most advanced technology, our goal is to become the world's largest human gene sequencing center." Illumina needs a lot of research to promote the market demand for genetic testing.
As Illumina, NGS representative, lowers the price threshold for testing, the market for gene sequencing will increase significantly.
Currently in the bud
The development of the gene sequencing industry in China is still in its infancy. The National Health and Family Planning Commission halted gene sequencing trials in February and quietly released it in March.
On March 13, the Jiangxi Provincial Health Planning Commission issued a “Circular on Launching the Application of High-throughput Genetic Testing Technology for Clinical Application of Pilot Unitsâ€. The notice shows that the National Health and Planning Commission sent a notice to the provincial health and planning committees to issue this notice.
The notice categorized some items of the pilot units, clarified the requirements for applying for pilot units for clinical applications, and required medical institutions other than the medical laboratory to apply for prenatal screening, prenatal diagnosis and preimplantation embryos. For genetic diagnosis projects, they must have corresponding technical qualifications and comply with relevant regulations.
This is a follow-up letter issued by the National Health and Family Planning Commission after the two ministries jointly called for gene sequencing of unlicensed clinical applications in February to announce the pilot application of clinical sequencing of gene sequencing. On February 9 this year, the State Food and Drug Administration (CFDA) and the Health and Family Planning Commission jointly issued a notice requesting that gene sequencing products be subject to the approval of the food and drug regulatory authorities, and that applications for technology access should be approved by the health and family planning administrative department.
This time it is allowed to carry out the application of high-throughput gene sequencing clinical application pilot units, indicating that the national level still supports the promotion of gene sequencing technology, but only to have the appropriate qualifications.
In fact, the sensitive A-share company is already gearing up. In October 2013, Zixin Pharmaceutical announced that it would collaborate with the Beijing Institute of Genomics, Chinese Academy of Sciences to develop a gene sequencing instrument project. The specific implementation unit will be the subsidiary Zhongke Zixin. In addition to Zixin Pharmaceutical, there are also Daan Genes, Kehua Biologicals and others involved in this field.
With the release of the genetic monitoring application by the Health and Family Planning Commission, the above-mentioned enterprises “relievedâ€. However, because the pilot clinical report required that "high-throughput gene sequencing technology has been developed," and it did not accept medical institutions newly reporting business, it showed that the Health and Family Planning Commission was still very cautious about this.
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