Since the US Obama proposed the precision medical plan, gene sequencing has entered a period of rapid development. Non-invasive prenatal genetic testing (NIPT) is the first product in China to obtain three types of medical device registration qualifications and to be approved for clinical marketing. The data show that last year China completed the prenatal genetic testing of 1 million pregnant women, and will maintain a compound annual growth rate of 20%-25% in the next 2-3 years, and the market scale will reach 10 billion level in the next five years. Like NIPT, preimplantation genetic diagnosis/screening (PGD/PGS) is also based on high-throughput sequencing technology for chromosome screening and diagnostics. How is the technology currently developing? How is the state regulated? In this regard, Bio-Exploration has released the following report:

Following NIPT, PGS became the next explosion of medical device innovation in the second generation of sequencing

Development of PGD/PGS

Like NIPT, preimplantation genetic diagnosis/screening (PGD/PGS) is also based on high-throughput sequencing technology for chromosome screening and diagnostics. How is the technology currently developing? How is the state regulated? In this regard, this report was released.

With the liberalization of China's comprehensive two-child policy, the number of elderly women has soared, and the rate of infertility has increased year by year. Increasing pregnancy rate and live birth rate has become an urgent problem to be solved. At present, the third generation of IVF represented by PGD/PGS is the key technology to solve these problems. In 2015, a study published in PLoS One conducted a meta-statistical analysis of more than 40 clinical trials that used to perform preimplantation testing through whole-chromosome screening. This statistical analysis involving about 10,000 samples confirmed that PGS detection can significantly improve (average 30%) implantation rate, pregnancy rate and live birth rate compared with the control group without PGS test, while abortion rate And the rate of multiple pregnancies has dropped significantly, up to 80%.

According to the statistical report of Huachuang Medicine, 1-2 cells were taken from the blastomere on the 3rd day of in vitro fertilization, or 3-10 trophoblast cells were taken from the blastocysts on the 5th and 6th day for genetics. Analysis, the cost of a cell test is 2000-3000 yuan, there are 1.3-156 million couples of assisted reproductive surgery each year, assuming that 30% of these couples are willing to do preimplantation genetic diagnosis, then The market size of the sector is about 10 billion yuan.

PGS's national regulatory process

According to the CFDA's "Special Approval Process for Innovative Medical Devices (Trial)", the Innovative Medical Device Review Office will define the category of medical device management when reviewing applications for special approval for innovative medical devices. It is learned from CMDE that China has classified PGS as the third category of medical devices for supervision and management.

The three types of medical devices are the highest-level medical devices, and they are also medical devices that must be strictly controlled. The production needs to be examined and approved by the drug regulatory authority under the State Council, and a product registration certificate is issued. PGS is defined as a third type of medical device product, which means that any PGS product used in hospitals must meet the national three categories of medical device standards, and obtain three types of medical device registration certificate, and the platform for product development must also obtain Three types of medical device registration certificates.

This year, CMDE announced the PGS products that have been specially approved for innovative medical devices, including the kits developed by Suzhou Beacon Medical Devices Co., Ltd. and Hangzhou Berry and Kang Gene Diagnostic Technology Co., Ltd.

The first batch of PGS products that received special approval for innovative medical devices

According to CMDE, on May 13, the country announced the first PGS product to receive special approval for innovative medical devices, namely the pre-implantation chromosome aneuploidy test kit developed by Beacon Medical. The kit is based on the DA8600 platform certified by Daan Gene and is developed using semiconductor sequencing. DA8600 is a widely used sequencing platform in China. It has the advantages of high throughput and fast sequencing speed. It only needs 10 samples to be turned on, which is convenient for medical institutions to carry out screening business. Based on the platform, NIPT developed by Daan Gene was also the first to receive special approval for innovative medical devices, so it has a leading position in the domestic market layout of NIPT and PGS.

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