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华大基因(300676.SZ):华大数极的人粪便DNA甲基化检测产品取得医疗器械注册证

Huada Gene (300676.SZ): Huada Digital Human Fecal DNA Methylation Testing Product Obtains Medical Device Registration Certificate

Gelonghui Finance ·  Dec 18, 2023 03:28

Glonghui December 18丨Huada Gene (300676.SZ) announced that the SDC2, ADHFE1, and PPP2R5C gene methylation joint test kit for human SDC2,, and PPP2R5C gene methylation, a wholly-owned subsidiary of the company, recently obtained a medical device registration certificate issued by the State Drug Administration.

The kit products approved this time are used to qualitatively detect the methylation of SDC2, ADHFE1, and PPP2R5C genes in intestinal exfoliated cells in human stool samples in vitro. The kit is based on a fluorescence quantitative PCR testing platform and has the characteristics of excellent detection performance for bowel cancer and advanced adenoma, flexible detection throughput configuration, etc., and can meet the diverse and individualized needs of clinical users.

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