On October 23, Gelunhui announced that the self-developed PGT-A test kit medical instrument registration certificate (registration number: Guoxiezhun 20203400181) successfully obtained the approval for renewal from the National Medical Products Administration in October 2024, extending its registration certificate for five years until February 20, 2030 (renewable).
In February 2020, the company's PGT-A test kit obtained the first domestic Class III medical instrument registration certificate for "innovative medical instruments special approval". Based on Qualcomm's high-throughput sequencing technology, the test kit can accurately detect the DNA of trophectoderm cells in embryos, analyze whether the embryo has chromosomal aneuploidy abnormalities, provide a basis for doctors to determine the suitability of embryos for implantation, and fill the clinical gap in the field of domestic PGT testing kits.
The PGT-A test kit is the first domestically validated PGT testing kit with clinical effectiveness confirmed by more than 0.1 million clinical samples. Since the clinical trial of the PGT-A test kit began, the company has collected clinical data of over 0.1 million embryos in clinical trial institutions. The consistency with the testing results of the PGT-A test kit reached 100%, fully proving its ability to effectively meet current clinical testing needs. The National Medical Products Administration's approval for the renewal of the PGT-A test kit medical instrument registration certificate also indicates that its clinical effectiveness has been recognized by the regulatory authorities.
