The first domestic PGT-A kit approved by NMPA, Chinese no need to go abroad to have IVF treatment!
The 10th China Medical Device Summit forum (device China 2020) was held on September 17, 2020. During the conference, Basecare held product launch for PGS (Preimplantation genetic testing for aneuploidy) kit, Xu Wenqing, Secretary of the Party Working Committee of Suzhou Industrial Park Science and Education Innovation Zone, Yin Jianguo, vice president of Suzhou Industrial Park biological industry Development Co., Ltd., and Mao Caiping, director of reproductive medicine center of the First Affiliated Hospital of Suzhou University and other leaders and experts attended the conference.
As a "national innovation" medical device, the launch of PGS kit makes our country out of the dilemma of lack of certified domestic reagents for preimplantation genetic testing for aneuploidy. In 2015, the CFDA Standard Management Centre officially classified PGT as "Class III medical devices" for supervision. The PGT-A kit was granted special approval for innovative medical devices by the CFDA Medical Device Technology Evaluation Centre in May 2016. After more than 4 years of clinical trials, the PGT-A kit independently developed by Basecare won the CFDA approval and became the first PGT-A product in China to have obtained the Class-III Medical Devices Registration certificate (approval number 20203400181). This success marks the beginning of a new era, in which China’s preimplantation genetic testing technology is licensed and under official supervision.
In domestic medical institutions, ordinary people can use domestic made PGS kit for gene detection, infertility patients no need to go overseas to do preimplantation genetic testing for aneuploidy, which will save a lot of money and manpower. In the future, the technology will help 50 million infertile couples in China to receive high quality PGT-A detection services at lower cost.
In an interview with the media, Rui Maoshe, operation director of Basecare told the media that the technology is to take a few cells from the embryo for genome-wide testing at the early stage of embryo development, and select normal embryos for implantation in order to improve the success rate of pregnancy and give birth to a healthy baby. This product is the first clinically registered product to realize complete screening of 23 pairs of chromosomes, and the detection cycle is shortened from 1 week to 1 day. According to clinical statistics, the success rate of clinical pregnancy has been increased from 46% to 72%, and the abortion rate has been reduced from 33% to 6.9%, indicating that the launch of PGS kit will help more infertile patients achieve the wish of having a healthy baby.
According to the research data of Frost Sullivan, China’s market size of the assisted reproduction market is about 100 billion yuan, and the market for PGT-A detection has increased from about 300 million yuan in 2015 to 2.5 billion yuan in 2019, with a compound growth rate of 70.8, and it is expected to reach 25 billion yuan in 2024. The innovative technology of PGT-A provides a new choice for the infertile couples, and brings new hope for couples with genetic diseases.