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At present, the global big health industry is developing vigorously. As a field closely related to life and health, the importance of the precision medicine industry is self-evident. XIAMEN SPACEGEN Co., Ltd. (abbreviated as "SPACEGEN") is a high-tech molecular diagnostic biology enterprise integrating R&D, production, sales and service. The company leads technological innovation guided by clinical needs ,providing high-quality and accessible molecular diagnostic products and services, covering the whole-cycle of cancer management , including early screening, disease diagnosis, individualized medication guidance and continuous curative effect monitoring.
SPACEGEN owns 3,500 square meters of international standard GMP workshop and 2,000 square meters of research and development/quality control laboratory. SPACEGEN has a perfect quality management system, and has passed the TUV ISO 13485 medical device quality management system certification. SPACEGEN has wholly-owned subsidiaries Xiamen SpaceSeq MedLab Co., Ltd. (abbreviated as "Xiamen SpaceSeq") and Suzhou SpaceSeq MedLab Co., Ltd. (abbreviated as "Suzhou SpaceSeq").
Xiamen SpaceSeq and Suzhou SpaceSeq, as a wholly-owned subsidiary of SPACEGEN, are equipped with four core technology platforms including high-throughput sequencing, fluorescent quantitative PCR, digital PCR and nucleic acid mass spectrometry, and have the laboratory qualifications for tumor molecular detection, pathogenic infection detection and drug metabolism detection. The laboratories have passed the NCCL/CAP/EMQN domestic and foreign room quality evaluation with full scores for consecutive years. The operation of the quality management system has obtained the authoritative certification from CAP of the United States, and the test results have global mutual recognition and international credibility.
SPACEGEN has a scientific research and technology team with Ph.D. as the research leader and master as the backbone.SPACEGEN has independently developed more than 50 products. Among them, nearly 30 products, such as EGFR Gene Mutations Detection Kit, Oncology Multi-Gene Mutations Detection Kit, Human Endometrial Cancer Molecular Classification Detection Kit, etc., have obtained EU CE-IVD certification. SPACEGEN has independent patented RingCap® technology, which is a targeted sequencing library preparation technology based on multiplex PCR. The library construction only needs two steps and can be completed in 3.5 hours, breaking the international technology monopoly and realizing import substitution.
SPACEGEN's service network covers the whole world. More than 1,000 medical and health institutions, scientific research institutes and pharmaceutical enterprises have trusted and used the overall gene sequencing solution of SPACEGEN, providing valuable tumor accurate diagnosis service for hundreds of thousands of tumor patients. The team is brave enough to overcome difficulties and make steady progress. SPACEGEN's bio-molecular diagnosis products are exported to more than 30 countries and regions on five continents in the world and have won the recognition from customers all over the world with high-quality products and technical support.
SPACEGEN always takes "Benefiting the Health of the Public" as its own responsibility and "leading international professional molecular diagnosis company" as its goal. Practice the values of "Quality First, Reputation First, Management Oriented, Sincere Service", strive to move forward, repay society with good results and benefit patients. SPACEGEN continuously pushes forward the comprehensive transformation of gene sequencing technology into clinical application, adding bricks and tiles to health care, protecting life and health, and enabling accurate diagnosis and effective treatment of each disease.