BASECARE-B (02170): The PGT-A test kit has been issued a medical device registration certificate by the National Medical Products Administration.

BASECARE-B (02170) announced that, based on the domestic high-throughput gene sequencing platform, the PGT-A assay kit for pre-implantation embryo chromosome aneuploidy testing (using probe anchoring polymerase chain reaction sequencing), was successfully approved for national Class III medical device registration on March 13, 2026 (registration number:20263400529). It became the first PGT-A assay kit in the country based on a purely domestic independent platform sequencer. This assay kit is suitable for in vitro fertilization patients aged 35 and above, couples with chromosomal abnormalities, individuals with three or more failed transplants or miscarriages, and families with children with abnormal birth conditions. By analyzing the chromosome aneuploidy in embryo cells, it assists in clinical implantation decision-making, marking a breakthrough in the localization of the complete chain of "equipment - reagents - analysis software" in the field of assisted reproduction genetic testing in our country, injecting strong "Chinese core" into China's health industry. The PGT-A assay kit screens for embryo chromosome aneuploidy, effectively reducing the risk of miscarriage and the incidence of birth defects, serving as a key support for the third generation of IVF technology. The assay kit approved by the company this time has undergone years of technical breakthroughs, completing multi-center systematic validation in terms of detection accuracy, platform adaptability, and clinical utility, filling the application gap of purely domestic independent platform sequencers in the PGT-A field, providing a more autonomous and controllable testing choice for clinical use.