BASECARE-B (02170) Receives NMPA Medical Device Registration Certificate for PGT-A Kit

Stock News
03/16

BASECARE-B (02170) announced that its PGT-A kit, the Preimplantation Genetic Testing for Aneuploidy Kit (based on the cPAS sequencing method) developed on a domestic high-throughput gene sequencing platform, successfully obtained a National Class III Medical Device Registration Certificate on March 13, 2026 (Registration Certificate No.: National Instrument Approval 20263400529). This makes it the first PGT-A kit in China based entirely on a domestically developed sequencing platform. The kit is intended for use in IVF patients aged 35 and above, couples with chromosomal abnormalities, individuals with more than three failed embryo transfers or recurrent miscarriages, and families with a history of abnormal births. By analyzing DNA from embryonic cells to detect chromosomal aneuploidies, it assists in clinical implantation decisions, marking a breakthrough in the full-chain localization of "equipment—reagents—analytical software" in China's assisted reproductive genetic testing sector and injecting a strong "Chinese core" into the nation's healthcare industry. The PGT-A kit helps effectively reduce miscarriage risks and the incidence of birth defects by screening embryos for chromosomal aneuploidies, serving as a key support for third-generation IVF technology. The approved kit is the result of years of technical development and has undergone multicenter systematic validation for detection accuracy, platform compatibility, and clinical utility. It addresses the previous gap in the application of fully domestic sequencing platforms in the PGT-A field, offering clinicians a more autonomous and controllable testing option.

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