Company Profile

About SpaceGen

Serve public health and benefit mankind

SpaceGen

Xiamen SpaceGen Co., Ltd., integrating R&D, production, sales and advisory services, is dedicated to providing the most innovative products and services for cancer, genetic diseases and other personalized precision medical testing.We provide the products with total solution for early screening, disease diagnosis, personalized drug selection and efficacy monitoring of treatment.

The company has a strong scientific research and technical team, equipped with high-throughput sequencing platform, digital PCR platform, fluorescence quantitative PCR platform, nucleic acid mass spectrometry platform, etc., and based on this independent research and development of more than 60 kinds of products, applied for 41 domestic patents, 3 international PCT patents,1 United States Patent, 12 invention patents, 3 utility model patents and 24 soft works have been authorized.

SpaceGen has received TUV ISO 13485 certification for medical device quality management and CAP(College of American Pathologists) certificate of accreditation. 25 products have been achieved CE certification including Human Oncology Multi-Gene Mutations Detection Kit, Human BRCA1/2 Gene MutationsDetection Kit, Human EGFR Gene Mutations DetectionKit, Human K-ras Gene Mutations Detection Kit,Human B-raf Gene Mutation Detection Kit,Human Pharmacogenomics SNP Detection Kit, Human MGMT Gene Methylation Detection Kit,Breast-Ovarian Cancer Combined Gene Detection Kit and Human EGFR Gene T790M Mutation Detection Kit,etc. CE certifications for  more products are been applied now.

SpaceGen adheres to the business philosophy of ”Quality first, credibility focused, management oriented, service centered”, and abides by the corporate culture of "giving each patient accurate diagnosis and effective treatment!".Spacegen commits to becoming a pioneer enterprise in personalized precision medical industry and strives for the cause of human health by providing the majority of medical workers and patients with professional, high-quality precision medical solutions.


100000+

Provide valuable accurate tumor diagnosis services for more than 100,000 tumor patients

5000+

More than 5000 medical institutions, scientific research institutes and enterprises use SpaceGen's overall gene sequencing solution

100+

Serving more than 100 overseas medical institutions

History
2026
2025
2024
2023
2022
2021
2020
2019
2018
2017
2016
2015

January

Granted a U.S. invention patent——“Library construction method for detecting endometrial cancer-related gene mutations based on high-throughput sequencing”(Patent No. : US 12,553,152 B2)

December

Signed a strategic cooperation agreement with Autobio Biological to establish a comprehensive cooperation framework

October

The industry standard "Gene mutation in tumor tissue detection kit(high-throughput sequeneing)", which was drafted with our participation, has officially been implemented

March

The quality system has obtained the internationally authoritative certification from CAP in the United States

March

The quality system of SpaceGen Medical Laboratory obtained the internationally authoritative certification from CAP in the United States

April

The wholly-owned subsidiary, Suzhou SpaceSeq MedLab Co., Ltd.,a third-party medical laboratory, was established and obtained a medical institution practice license

February

9 products obtained the EU CE-IVD certification

March

"Human K-ras Gene Mutation Detection Kit (Multiplex Fluorescence PCR)" was approved for marketing by the National Medical Products Administration

January

Completed another financing of nearly 100 million yuan

November

Establishment of Suzhou SpaceSeq MedLab

June

Signed a strategic cooperation agreement with Guangzhou Wondfo Katis Biotechnology Co., Ltd

February

the "Oncology Multi-Gene Mutations Detection Kit " obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA)

February

Completed Series B financing of nearly 100 million yuan

December

Reached a strategic cooperation with Cygnus Biosciences (Beijing) Co., Ltd. and completed a C-round financing of hundreds of millions of yuan

June

the "Human EGFR Gene Mutation Detection Kit (Multiplex Fluorescence PCR Method)" obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA)

April

Signed strategic cooperation agreements with Agena Bioscience ("Agena") from the United States and Guangzhou Darui Biotechnology Co., Ltd

July

6 products obtained CE-IVD certification

February

The invention patent for RingCap®, a proprietary link amplification technology, was authorized by the China National Intellectual Property Administration

March

Won the title of "Double Hundred Plan" Leading Entrepreneurial Talent Settled Enterprise in Xiamen

March

Obtain CE-IVD certification for 5 products in the European Union

July

Obtained national and municipal high-tech enterprise certificates

August

Passed the German TUV ISO13485 medical device quality management system certification

August

Obtained nearly 40 million yuan in financing co-participated by Jingxu Venture Capital, Jingyuan Lanhai, and Dongfang Yirui

September

The core product obtained special approval from the National Medical Device Innovation Fund

February

Angel round - Qiao Jing Capital invested tens of millions

June

Pre-A: Completed a tens of millions strategic investment with Darui Biotech

June

The self-developed library kit for gene sequencing passed the certification of the Food and Drug Administration and obtained a Class I medical device registration certificate

June

Company establishment

Honors

Certification

Qualifications

External quality assessment (EQA)

CAP Accreditation Certificate (Xiamen SpaceGen MedLab)

CAP Accreditation Certificate (Xiamen SpaceGen MedLab)

CAP Accreditation Certificate (Suzhou SpaceSeq MedLab)

CAP Accreditation Certificate (Suzhou SpaceSeq MedLab)

TUV ISO 13485 Accreditation Certificate

TUV ISO 13485 Accreditation Certificate

United States Patenta—Endometrial Cancer

United States Patenta—Endometrial Cancer

PCT International Patent—RingCap

PCT International Patent—RingCap

CE Certificate(9 products)

CE Certificate(9 products)

CE Certificate(12 products)

CE Certificate(12 products)

CE Certificate(Monkeypox Virus)

CE Certificate(Monkeypox Virus)

CE Certificate(3 products)

CE Certificate(3 products)

PCR Clinical Gene Amplification Testing Laboratory

PCR Clinical Gene Amplification Testing Laboratory

NGS Clinical Gene Amplification Testing Laboratory

NGS Clinical Gene Amplification Testing Laboratory

National High-tech Enterprise

National High-tech Enterprise

Medical Institution Practice License

Medical Institution Practice License

Medical Device Manufacturing License

Medical Device Manufacturing License

Medical Device Business License

Medical Device Business License

2025 NCCL—Chikungunya virus(CHIKV)

2025 NCCL—Chikungunya virus(CHIKV)

2025 NCCL—COVID-19‌

2025 NCCL—COVID-19‌

2025 NCCL—HPV

2025 NCCL—HPV

2025 NCCL—EGFR

2025 NCCL—EGFR

2025 NCCL—KRAS

2025 NCCL—KRAS

2025 NCCL—BRAF

2025 NCCL—BRAF

2025 NCCL—EML4-ALK

2025 NCCL—EML4-ALK

2025 NCCL—NGS(Solid Tumor)

2025 NCCL—NGS(Solid Tumor)

2025 NCCL—NGS(cfDNA)

2025 NCCL—NGS(cfDNA)

2025 NCCL—A

2025 NCCL—A

2025 NCCL—B

2025 NCCL—B

2025 NCCL—SLCO1B1

2025 NCCL—SLCO1B1

2025 NCCL—MTHFR

2025 NCCL—MTHFR

2025 NCCL—Bioinformatics

2025 NCCL—Bioinformatics

2025 NCCL—Prenatal Screening

2025 NCCL—Prenatal Screening

2025 NCCL—Endocrine

2025 NCCL—Endocrine

2025 CAP—NGSST−A

2025 CAP—NGSST−A

2025 Jiangsu —BRAF

2025 Jiangsu —BRAF

2025 Jiangsu—HPV

2025 Jiangsu—HPV

2025 Jiangsu—KRAS

2025 Jiangsu—KRAS

2025 Jiangsu—EGFR

2025 Jiangsu—EGFR

Sailing with strength towards the world

Our footprints extend to over 30 countries and regions,We have served over 100 overseas medical institutions,From deep cultivation in mature markets to tapping into the potential of emerging regions,Continuously expanding the boundaries of overseas markets,Let the world see China's precise solutions.

Sailing with strength towards the world