Sequencing of gene-based sequencing

Gene detection technology is a major revolution in the development of life sciences and biotechnology. In order to speed up the popularization of genetic testing technology and promote the industrialization of major innovations, Hunan Province and Guizhou Province have issued policies on supporting the application of gene sequencing technology in recent times.

Guizhou Province: "Supporting Genetic Testing Technology Application Policy Measures (Trial)"

A few days ago, Guizhou Province publicly released support policies for "Supporting Genetic Testing Technology Application and Policy Measures (Trial)". The policy mainly supports the following nine aspects: the establishment of a networked gene sequencing organization system, support for the expansion of business space, exploration of the scope of reimbursement for medical insurance coverage, support for the development and industrialization of gene sequencing technologies, support for the construction of a talent team, increased financing support, and implementation of fiscal and tax support policies Implement government procurement policies and strengthen organizational coordination. This policy proposes to enjoy a full-free policy for genetic screening for birth defects in two separate pregnant mothers.

Perfecting the system of genetic testing fees: All ages are separated and the two-child pregnant women are born with genetic defects.

In order to promote the popularization of gene sequencing, Guizhou’s policy explored a diversified payment mechanism, summarized the experiences of non-invasive prenatal gene detection, neonatal deafness gene testing, and cervical cancer (HPV) screening trials in Xingyi City, southwest Guizhou Province, and explored the establishment of financial subsidies and medical insurance. The genetic testing and payment mechanism jointly undertaken by reimbursement and personal out-of-pocket payment was timely promoted to the entire province. Accelerate the promotion of therapeutic drug gene testing and genetic testing for rare diseases. Two-child mothers with separate older ages have the full-free policy of screening for birth defects such as Down syndrome.

Support the development of business space: Use of genetic testing technology for precision medicine and personalized medicine

The policy proposes to support grassroots medical and health institutions to outsource medical inspection services to qualified genetic testing agencies. Encourage qualified regions to promote genetic screening for inherited diseases such as genetic deafness and Down syndrome in newborns through government procurement; adopt a combination of government procurement and patient self-pay to conduct genetic screening for thalassemia and Prenatal diagnosis, noninvasive DNA testing for elderly mothers, and genetic testing for major diseases such as cancer, cardiovascular and cerebrovascular diseases, and infectious diseases. Based on the establishment of a precision medicine center at the Cancer Hospital of Guizhou Medical University, genetic testing technology is used to develop precise medical treatment and individualized medications to improve treatment effectiveness and safety.

Hunan Province: "Hunan Province Promoting Genetic Testing Technology Application (Trial)"

On August 28, 2015, the People's Government of Hunan Province issued a circular on the “Provision of Policies for the Promotion of the Application of Genetic Testing Technology in Hunan Province (Trial)”. In order to speed up the development and popularization of gene detection technology in Hainan Province, 12 policies were proposed, including To carry out and promote genetic testing of genetic diseases, conducting genetic testing pilots, vigorously promoting personalized medicine, and incorporating part of the cost of genetic testing into medical insurance, etc., in the form of government procurement.

According to this policy, Hunan will select a number of pilot areas to carry out special applications of genetic testing technology, aiming at children with intellectual disabilities who are children with mental retardation or one of the couple, and there is no family planning special family for surviving children. The government special fund and the designated qualified medical institution jointly funded the development of "proband diagnostics" and prenatal diagnostic services free of charge to reduce the birth probability of birth defects.

Gene sequencing into medical insurance, second child eugenics is expected to spread

The correlation between second-child policy and genetic sequencing

In recent days, the news of the full release of the two children broke the pot for a while and went to the headlines of major media. There are also more and more reports on the impact of the second-child policy on gene sequencing. The adjustment of childbirth policy is not only an opportunity but also a challenge for practitioners in the genetic industry, especially those for non-invasive prenatal genetic testing related projects in China.

According to the data in the Guangxu Hang Seng research report, the second-child policy will expand the market size of second-generation gene sequencing in the area of ​​prenatal and postnatal care to at least 1.1-1.2 times, which is approximately 3 billion yuan; and non-invasive prenatal testing (NIPT) as the second The most mature field of application of gene sequencing, the second-child policy will or will make its market will expand to about 20 billion yuan; Preimplantation genetic diagnosis (PGD), the third-generation test-tube baby, its market expansion required The three major catalytic factors are the second-generation gene sequencing technology, policy liberalization, and market demand. Therefore, the PGD market is expected to expand to about 10 billion yuan when it meets various conditions.

Non-invasive prenatal testing (NIPT) and second child eugenics

In the new century, China’s population development has undergone major changes. The growth momentum of the total population has been significantly weakened, the working-age population has begun to decline, the ageing degree has continued to deepen, the function of family care and child care has weakened, and the lack of birth has become the mainstream of social fertility concepts. The two-child policy is fully liberalized and eugenics will continue to be the mainstream of social fertility concepts. How to have a eugenics, prenatal testing of pregnant women here plays an important role.

Non-invasive prenatal testing (NIPT) was introduced in the United States and Western Europe at the end of 2011 and was quickly commercialized in the Middle East, South America, South Asia, Southeast Asia, and Africa. Non-invasive prenatal testing has also encountered many difficulties before it officially entered orbit. In February 2014, the National Health and Family Planning Commission urgently called off domestic non-invasive prenatal genetic testing and other projects. However, in December 2014, the National Health and Family Planning Commission carefully relinquished genetic disease diagnosis, prenatal screening and diagnosis, and implantation. The pilot application units of pre-embryology genetic diagnosis and other projects have officially opened the second generation of gene sequencing for medical clinical related projects.

With the deepening of research, the conditions and scope of non-invasive testing are expected to expand and extend to include microdeletions/duplication syndromes and common Mendelian inherited diseases. The commercialization process of detecting chromosome aneuploidies is increasing, and the market scale has steadily increased. Early detection of chromosomes and other hereditary anomalies created conditions for better pregnancy care, and at the same time made it possible to mobilize limited medical resources more reasonably to serve the health management of neonates with genetic abnormalities.

In recent years, with the delay of environmental pollution and the age of childbirth, more and more pregnant women are older. After the second-child policy is released, the number of elderly mothers will increase. Research shows that the risk of chromosomal aneuploidy and other chromosomal diseases is significantly higher in high-risk and older pregnant women. NIPT clinical data showed that the positive rate of three major chromosome aneuploidies was about 1.36% in senior pregnant women, and the positive rate of three major chromosome aneuploidy in high-risk pregnant women was about 0.94%. The emergence of non-invasive prenatal testing has further optimized the prenatal diagnosis of elderly and high-risk mothers.

Gene sequencing into health insurance, eugenics

Non-invasive prenatal testing (NIPT) is the most mature field of application for second-generation gene sequencing. If genetic sequencing is incorporated into the medical insurance system, two-child births will benefit fishers. Now in China, local provinces have introduced policies in succession, and Guizhou has released the full-free policy for the screening of birth defects genes such as two-child pregnant women with Down syndrome. Hunan Province carries out "proband diagnostics" and prenatal diagnostic services for special family planning families free of charge to reduce the birth probability of birth defects.

The Guizhou government specifically pointed out the issue of fees for newborn screening and prenatal testing for the elderly. In order to improve the system of genetic testing fees, the Guizhou Provincial Government explored the establishment of a genetic testing payment mechanism jointly financed by financial subsidies, medical insurance reimbursement, and personal self-paid policies to encourage qualified regions to promote neonatal hereditary deafness and Down's Syndrome by government procurement. Screening genetic screening for genetic diseases and adopting a combination of government procurement and patient self-pay for genetic screening and prenatal diagnosis for thalassemia, non-invasive DNA testing for older women, and cancer, cardiovascular and cerebrovascular diseases and infectious diseases Gene testing for major diseases. This policy is undoubtedly a major positive news for the local second-born child!