On November 4, 2021, the National Medical Products Administration (NMPA) issued a public announcement approving the innovative product independently developed and manufactured by Beijing Zhongyi Kangwei Medical Device Co., Ltd. (a wholly-owned subsidiary of Jabrehoo), “Preimplantation Chromosomal Aneuploidy Detection Kit (Reversible Terminator Sequencing Method)” registration application, markingChina’s First PGT-A Testing Kit Using Reversible Terminator Sequencing Technology Officially Approved for Market Launch。
▲ Zhongyi Kangwei’s “Preimplantation Chromosomal Aneuploidy Detection Kit (Reversible Terminator Sequencing Method)” Approved for Market Launch (Image source: Official Website of the National Medical Products Administration)[1]）
Product Name: Preimplantation Chromosomal Aneuploidy Detection Kit (Reversible Terminator Sequencing Method)
Manufacturer: Beijing Zhongyi Kangwei Medical Devices Co., Ltd.
Registration Certificate No.: National Medical Device Registration No. 20213400868
This is China’s first preimplantation aneuploidy testing kit based on reversible terminator sequencing.Compared with similar products already approved for marketDifferent Sequencing Principles, embryonic chromosomal aneuploidyDifferent Algorithms。
JabrehooPGT-A Testing Kit Based on High-Throughput Sequencing Platform Using Reversible Terminator Sequencing Method, after a decade of independent research and development innovation, will- Female patients aged 38 years or older undergoing in vitro fertilization (IVF)- Couples in whom one or both partners have chromosomal abnormalities- Patients with more than three failed IVF implantation attempts- Patients with a history of more than three spontaneous abortions- Couples who have previously given birth to a child with chromosomal abnormalitiesProvides preimplantation genetic testing for aneuploidy (PGT-A), which helps patients select healthier embryos for transfer by identifying numerical abnormalities in the 23 pairs of chromosomes.
This kit is an in vitro diagnostic reagent developed based on the new generation of high-throughput sequencing platforms. It can qualitatively detect chromosomal number abnormalities in cells biopsied from blastocyst-stage embryos, and is used for qualitative detection of deoxyribonucleic acid (DNA) in trophectoderm cells of in vitro cultured embryos during the IVF process. By analyzing the DNA of a subset of embryonic cells, it determines whether there are aneuploid numerical abnormalities in the embryo's chromosomes, thereby assisting clinicians in deciding whether to implant the embryo.Preimplantation Genetic Testing for Aneuploidy (PGT-A)，Helps reduce the implantation of embryos with chromosomal abnormalities, thereby minimizing recurrent implantation failure, recurrent miscarriage, and birth defects caused by such implants; improves clinical pregnancy and live birth rates, assisting families in welcoming healthy newborns.。
In August 2016, Jabrehoo’s PGT-A test kit—Preimplantation Genetic Testing for Aneuploidy Kit (Reversible Terminator Sequencing Method)—was among the first to receive the NMPA’s “Special Approval for Innovative Medical Devices,” with acceptance number CQTS1600088. Over a period of five years and two months, through rigorous clinical studies, based on clinical testing data from 4,640 embryos obtained from 1,221 eligible subjects, and with refined and stringent quality control, it ultimately received NMPA approval."PGT-A First Certificate" Based on Reversible Terminator Sequencing”。
Reversible Terminator Sequencing: Delivering Superior Sequencing Accuracy
Reversible Terminator Sequencing, referring to Illumina's sequencing-by-synthesis chemistry, is the most widely used NGS sequencing chemistry worldwide.[2]This methodology detects each base as it is incorporated into the continuously extending DNA strand, enabling parallel sequencing of millions of DNA fragments. By leveraging the natural competitive mechanism among the four labeled nucleotides, incorporation bias is reduced, allowing for more stable sequencing of repetitive and homopolymer regions.[3], providing exceptional accuracy for sequencing assays.
Since 2013, the use of high-throughput sequencing technology for preimplantation genetic testing (PGT) in the field of assisted reproductive health has been increasingly recognized by clinical experts. Due to the fact that PGT involves single-cell samples, the precious nature of these samples, the technical complexity, and the clinical demand for high precision in test results have largely hindered the standardization and normalization of NGS quality systems. In September 2019, the PGT testing program of Jiabao Laboratory, a medical laboratory under Jabrehoo, became the first in the world to pass the comprehensive on-site inspection by reviewers from the College of American Pathologists (CAP) and obtain the official CAP certification. This marks the formal entry of Jiabao Laboratory’s PGT testing program into the ranks of internationally authoritative clinical laboratory standard quality certification systems.
The approval of Jabrehoo’s PGT-A testing kit signifies that Jabrehoo’s PGT-A testing has received dual recognition both domestically and internationally, namelyThe only company in China with PGT-A testing services to have obtained dual certification from the NMPA and CAP, with its testing capabilities having undergone rigorous dual review by relevant domestic and international regulatory frameworks and quality control standards.。
Peking Jabrehoo Med Tech Co., Ltd. stated: We extend our heartfelt gratitude to all clinical trial sites, enrolled patients, and their families for their dedication and trust; to the relevant experts at the National Medical Products Administration for their meticulous guidance on innovative products; to our partner Illumina for their full support and cooperation; and to our CRO partner, Beijing Baoli Yongchang Shengji Pharmaceutical Research Technology Co., Ltd. (Baoli Shengke NewBioray), for their comprehensive assistance throughout the entire process, from innovative application to clinical trials and regulatory submission.
References:
[1] Official Website of the National Medical Products Administration
https://www.nmpa.gov.cn/yaowen/ypjgyw/20211104150850147.html?type=pc&m=
[2] Data calculations on file. Illumina, Inc. 2017.
[3] Bentley DR, Balasubramanian S, Swerdlow HP, et al. Accurate Whole Human Genome Sequencing using Reversible Terminator Chemistry. Nature. 2008;456(7218):53-59.
