Daan gene: CFDA registration certificate of second generation sequencer and noninvasive prenatal testing kit

Source: Bioscience 2014-11-06 on November 5, 2014, the State Food and Drug Administration approved the registration of gene sequencer of Daan gene and medical device of fetal chromosome aneuploidy 21 trisomy, 18 trisomy and 13 trisomy detection kit (semiconductor sequencing method) At present, Huada gene and Daan gene, the only two domestic units that have obtained the national second generation sequencer and non-invasive prenatal kit registration acceptance number, have officially obtained the second generation gene sequencing diagnostic products approved by the State Food and drug administration As early as June 19 this year, the above batch of products of Da'an gene entered the national innovative medical device special approval green channel The approved sequencer and detection kit of Da'an gene this time can carry out non-invasive prenatal testing Through gene sequencing of free gene fragments in maternal peripheral blood plasma, 21 trisomy syndrome and 18 trisomy disease of fetal chromosome aneuploidy were detected- Trisomy and trisomy 13 syndrome were examined and diagnosed It is reported that Da proton, the gene sequencer approved by Da'an gene this time, is a domestic sequencer authorized by life technologies (acquired by Thermo Fisher), and the only one authorized for sale in the domestic market Its technology represents the most advanced level in the world, and its volume is only the size of a printer It is a sequencer specially designed for clinical application Da proton can provide the information of human genome, human exon group or whole transcriptome in a few hours through semiconductor chip, which is faster than other sequencing technologies and can fully meet the requirements of early, fast and low cost of non-invasive prenatal testing Before the screenshot of the notice from the State Food and drug administration, Huada gene's two gene sequencers and detection kits were the first to be approved by the State Food and drug administration So far, the only two domestic units authorized by the second generation sequencing registration have obtained the registration certificate, and the era of China's gene industry has officially kicked off Compared with the background of the two companies, BGI has strong scientific research ability, but lack of clinical experience from the start of scientific research services to clinical services; although Daan gene is the second company to obtain registration certificate, as a state-owned listed company, it has 20 Many years of clinical experience in molecular diagnosis has accumulated a large number of clinical channels and established a perfect service network, which can help hospitals to quickly establish a second-generation sequencing laboratory, so it is difficult to distinguish who can dominate the pattern of China's gene industry at present At the same time, many domestic companies have also joined in the application for registration certificates Some experts have questioned in microblog, can China really develop so many of the world's most advanced gene sequencers? From this point of view, it is an urgent national strategic issue concerning the safety of China's gene data that how to distinguish the false localization between the national regulatory authorities and the examination and approval authorities in the future In any case, as time goes on and the approval of sequencer and clinical pilot units by the state, we can see that the haze brought by the "stop order" for clinical application of gene detection jointly issued by the two ministries in February this year to the domestic gene detection market is gradually disappearing, and the large-scale clinical application of gene detection is coming At present, noninvasive prenatal testing is the most mature field of gene detection application in the domestic market According to statistics, using noninvasive prenatal testing, 100% penetration rate for high-risk pregnant women over 30 years old will bring 7.6 billion yuan of market capacity; 50% penetration rate for all pregnant women will bring 14 billion yuan of market capacity If the cost of sequencing is reduced to the level that everyone wants to know their own genetic information to guide daily health care and clinical medication, the market size will reach more than one trillion yuan, and the diagnostic industry will also change dramatically Daan gene, the main building of Daan gene, is a biomedical high-tech enterprise based on Sun Yat sen University, led by molecular diagnosis technology, integrating the research and development, production, sales of clinical testing reagents and instruments, and clinical testing services of national independent laboratory of chain medicine It was founded in 1988 and August 2004 It was listed for the first time in June and is the leading enterprise of molecular diagnosis in China At present, Daan gene's product line has covered almost all major technical fields including PCR under molecular diagnosis, including sequencing, chip, SNP and fish At the same time, it has extended its tentacles to the fields of Biochemistry and immunity, built the technology and product R & D system of parallel development of nucleic acid diagnosis technology platform, sequencing diagnosis technology platform, immunology diagnosis technology platform, cytology diagnosis technology platform, biochemical diagnosis technology platform and other emerging diagnosis technology platforms, and formed a leading R & D platform in China Chinese President Xi Jinping met with Daan gene led by Daan gene Limited by Share Ltd, which has formed a 32 covering the whole country The powerful marketing service network of provinces, cities and autonomous regions provides high-tech services in the field of products and inspection for thousands of medical institutions, scientific research institutions and government application platforms The company will develop into an integrated upstream and downstream supplier of China's diagnosis industry, and become a first-class and internationally renowned biological high-tech enterprise in the diagnosis industry in China