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On July 14, the official website of the State Food and Drug Administration released the medical device approval certificate.
The approval of GenoCare 1600 for clinical application is an important milestone in the development of Zhenmin.
Yan Qin, co-founder and CEO of Zhenmin Bio, said:
"The NMPA listing approval for the single-molecule sequencer obtained this time is a strong proof of Zhenmai's single-molecule sequencing technology and product service capabilities, and it once again demonstrates the country and the public's recognition of the important role of gene sequencers in the life and health industry.
The GenoCare 1600 single-molecule gene sequencer uses the single-molecule chip-based surface fluorescence sequencing technology SURFseq, and uses the principle of total internal reflection (TIRF) to identify the fluorescent signal of the base, and realize sequencing-by-synthesis
The approval of GenoCare 1600 means the beginning of the clinical diagnosis era of domestic single-molecule gene sequencing technology
grateful!
Sincere thanks to the clinical trial unit, the Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine, the China Welfare Society International Peace Maternal and Child Health Hospital, the teachers of Nanjing Maternal and Child Health Hospital, and the enrolled patients for their dedication and trust, and thanks to the CRO unit Tongze Hexin (Beijing) Pharmaceuticals Technology Co.
Make life readable and make health plastic! Standing at a new starting point, let us work together to promote the development of gene sequencing technology
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