What SpaceGen does

SpaceGen (Xiamen Spacegen Co., Ltd. / 厦门飞朔生物技术有限公司), founded in 2015 and headquartered in Xiamen, China, is a privately held molecular diagnostics company focused on individualized precision testing for solid tumors. The company's stack rests on four core technology platforms: next-generation sequencing (NGS), digital PCR (ddPCR), fluorescence quantitative PCR (PAP-ARMS®), and nucleic acid mass spectrometry (via the Agena MassARRAY system). Proprietary wet-lab methods include RingCap® (a multiplex PCR-based targeted sequencing library prep) and PAP-ARMS® (a high-specificity mutation detection PCR chemistry). SpaceGen has commercialized more than 60 IVD reagent kits spanning companion diagnostics (EGFR, KRAS, BRAF, HER2, ALK, ROS1), tumor multi-gene panels (13-gene and ~1,200-gene panoramas), endometrial cancer molecular subtyping, BRCA1/2 and HRD panels, hematological and rare-cancer assays, and methylation / fusion detection kits (NTRK, RET, MGMT, PAX1). The portfolio carries three NMPA Class III registrations, ten Class I filings, and 25 CE-IVD certifications, with a US patent (US 12,553,152 B2) granted for endometrial-cancer NGS library construction.

Name

SpaceGen

Legal name

Xiamen Spacegen Co., Ltd.

Website

https://ispacegen.com

Company type

Private

Founded year

2015

Headcount range

11–50 employees

Short description

SpaceGen is a China-based molecular diagnostics company that develops IVD kits and clinical testing services for precision tumor diagnosis across NGS, digital PCR, fluorescence PCR, and mass spectrometry platforms, serving 5,000+ medical institutions domestically and 100+ institutions across 30+ countries.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Molecular Biology & Genomics Instruments (PCR/qPCR, Sequencing, Microarrays) (HLAGAIAF), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Proteomics & Biomarker Analytical Testing (HLAGADAG)

Keywords

• Molecular diagnostic products
• Tumor genetic testing
• In vitro diagnostics
• Precision oncology diagnostics
• Clinical genetic testing

Headquarters

HQ city

Xiamen

HQ country

China

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations, Infrastructure

Revenue model

1. IVD Diagnostic Reagent Sales: SpaceGen develops and manufactures over 60 IVD diagnostic reagent products, including next-generation sequencing kits, real-time PCR kits, digital PCR kits, and nucleic acid mass spectrometry kits. These products are sold to hospitals, medical institutions, and laboratories domestically and internationally. 3 products hold NMPA Class III medical device registration certificates, 10 products have Class I medical device filings, and 25 products have CE-IVD certification.
2. Clinical Laboratory Testing Services: SpaceGen operates two CLIA-certified clinical laboratories (Xiamen SpaceGen MedLab Co., Ltd. and Suzhou SpaceSeq MedLab Co., Ltd.) providing genetic testing services to hospitals, physicians, and patients. Services cover tumor gene detection, molecular residual disease (MRD) monitoring, and other molecular diagnostic tests.
3. Equipment and Instruments Sales: Sale of laboratory equipment and instruments alongside diagnostic reagent kits to support molecular diagnostic testing workflows in clinical settings.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

SpaceGen develops, manufactures, and commercializes in vitro diagnostic (IVD) reagent kits for tumor molecular diagnostics and operates clinical testing laboratories providing genetic testing services. Its portfolio covers companion diagnostics (EGFR, KRAS, BRCA, BRAF, ALK, ROS1, NTRK, RET, ESR1, PIK3CA, AKT1, PTEN), MRD monitoring, molecular subtyping (e.g., endometrial ProMisE), and methylation-based screening, built on four core technology platforms: NGS, digital PCR, fluorescence quantitative PCR (PAP-ARMS), and nucleic acid mass spectrometry. Products are sold to hospitals, medical institutions, and overseas distributors, with clinical testing performed at its CAP-accredited MedLab subsidiaries.

Product overview

SpaceGen offers a comprehensive portfolio of over 60 R&D products and testing services organized around four core technology platforms: Next-Generation Sequencing (NGS), Digital PCR (ddPCR), Fluorescence Quantitative PCR (PAP-ARMS), and Nucleic Acid Mass Spectrometry. The product portfolio spans IVD kits (with 3 NMPA Class III registrations, 10 Class I filings, and 25 CE-IVD certifications) and clinical testing services through two CAP-accredited MedLab subsidiaries (Xiamen SpaceGen MedLab and Suzhou SpaceSeq MedLab). Key product lines include: (1) NGS-based panels — the flagship 6-gene (EGFR/KRAS/BRAF/HER2/ALK/ROS1) semiconductor sequencing kit (RingCap), 13-gene tumor panel, Endometrial Cancer Molecular Subtyping kit, BRCA1/2 panel, HRD Panel Set, and Tumor Panoramic Gene Panel (~1200 genes); (2) PAP-ARMS fluorescence PCR kits — EGFR (29 mutations), KRAS (7 mutations), BRAF, RET fusion, NTRK fusion (32 variants), PAX1 methylation, and MGMT methylation kits; (3) Breast Cancer ESR1 mutation kit (blood-based, 11 mutations); (4) MRD/ctHPV detection services for solid tumors including cervical cancer ctHPV monitoring. The company also provides GMP manufacturing (3500m²) and R&D/quality control laboratories (2000m²).

Differentiator

Problem solved

Functional benefit

Products and services

• Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing, RingCap) IVD kit for NSCLC companion diagnostics — simultaneous detection of 6 clinically actionable driver gene mutations (EGFR, KRAS, BRAF, HER2, ALK, ROS1) using semiconductor sequencing with proprietary RingCap chemistry. NMPA Class III registered for clinical use in Chinese hospitals.
• Human Tumor 13 Gene Mutation Detection Kit (NGS)

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature3 records

Partnerships

Seven partnerships are on record, tiered major and minor.

• Zhengzhou Antu Bioengineering Co., Ltd. (郑州安图生物工程股份有限公司)majorChannel Partner/ Reseller/ Distributor · 1 December 2024SpaceGen entered into a strategic cooperation agreement with Antu Bioengineering to build a comprehensive collaboration framework. Antu Bioengineering serves as the primary channel distributor for SpaceGen's sequencing products in China. In March 2026, SpaceGen and Antu Bioengineering jointly hosted a 'Sequencing Products Channel Exchange Conference' in Xiamen with over 100 channel partners from across China. Antu's Sikun gene sequencer series products use 'reversible terminator sequencing' technology and are compatible with SpaceGen's reagents.
• Chinese Academy of Sciences University of Science and Technology - First Affiliated Hospital (中国科学技术大学附属第一医院/安徽省立医院) - Prof. Zhou Ying TeammajorStrategic or Co-development Partner · 1 January 2024SpaceGen collaborated with Prof. Zhou Ying's team at the First Affiliated Hospital of USTC on a prospective study (NCT06456112) using ddPCR and NGS to detect circulating tumor HPV DNA (ctHPV) in cervical cancer for MRD monitoring. Results were presented at ASCO 2026. Funded by Anhui Provincial Education Department (2024AH040260).
• Agena Bioscience (美国Agena Bioscience)majorTechnology or IntegrationSpaceGen established a strategic cooperation with Agena Bioscience for nucleic acid mass spectrometry technology. SpaceGen has developed multiple products based on Agena's MassARRAY system, including UGT1A1 gene polymorphism detection and mucormycosis detection kits.
• Guangzhou Darrich Biotech Co., Ltd. (广州市达瑞生物技术股份有限公司)majorStrategic or Co-development PartnerSpaceGen signed a strategic cooperation agreement with Darrich Biotech for technology and product collaboration in the molecular diagnostics field. Darrich Biotech also made a Pre-A strategic investment in SpaceGen.
• Saisen Biotechnology (Beijing) Co., Ltd. (赛纳生物科技(北京)有限公司)majorTechnology or IntegrationSpaceGen entered into a strategic cooperation with Saisen Biotechnology and completed a C-round financing of over 100 million RMB. Saisen is a domestic NGS sequencing platform provider, and SpaceGen's products are compatible with the Sikun gene sequencer platform.
• Guangzhou Wankadi Molecular Diagnostics Co., Ltd. (广州万孚卡蒂斯生物技术有限公司)minorStrategic or Co-development PartnerSpaceGen signed a strategic cooperation agreement with Wankadi Molecular Diagnostics for collaborative development and market expansion in the molecular diagnostics sector.
• TUV SÜD (南德TUV)minorOthersTUV SÜD certified SpaceGen's quality management system to ISO 13485 standard for medical devices.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Emerging players

• Diacarta: Diacarta is a precision diagnostics company developing liquid biopsy and molecular diagnostic tests for cancer detection, including qPCR and NGS-based assays. Comparable to SpaceGen's MRD, ctHPV, and mutation detection products, with overlapping technology approaches (ddPCR, NGS) and oncology focus, but with stronger US clinical presence and FDA submissions.
• Caris Life Sciences: Caris Life Sciences is a US-based precision oncology company offering comprehensive molecular profiling (MI Profile), liquid biopsy, and AI-driven analytics. It is comparable to SpaceGen's pan-cancer Tumor Panoramic Gene Panel and HRD Panel in providing comprehensive tumor genomic profiling services, though focused on the US market with different regulatory and reimbursement dynamics.

Direct peers

• Burning Rock Biotech: Burning Rock Biotech is a publicly listed Chinese oncology NGS company providing both central laboratory testing services and IVD reagent kits for cancer companion diagnostics and MRD. It overlaps directly with SpaceGen's tumor precision diagnostics business across multiple cancer types and offers similar evidence-generation at scale through clinical research collaborations.
• Novogene: Novogene is a leading Chinese sequencing services provider offering NGS-based oncology testing, genomic profiling, and bioinformatics services to hospitals and research institutions. It is comparable to SpaceGen's clinical laboratory services business (Xiamen SpaceGen MedLab and Suzhou SpaceSeq MedLab) and overlaps in tumor gene sequencing offerings.
• Amoy Diagnostics: Amoy Diagnostics (AmoyDx) is a Chinese oncology molecular diagnostics company specializing in PCR and NGS companion diagnostic kits for EGFR, KRAS, BRAF, ALK, ROS1 and other biomarkers. It is the closest direct competitor to SpaceGen in the China NSCLC and colorectal cancer CDx market, with comparable NMPA Class III registrations and CE-IVD certifications.
• Genetron Health: Genetron Health is a Chinese precision oncology company providing NGS-based cancer profiling, MRD monitoring, and companion diagnostics via both LDT services and IVD products. It competes directly with SpaceGen in the hospital-channel oncology NGS market in China and serves overlapping customer segments of tertiary hospitals and research institutions.
• Agena Bioscience: Agena Bioscience is the US-based developer of the MassARRAY nucleic acid mass spectrometry platform, which SpaceGen integrates with for products like UGT1A1 polymorphism and mucormycosis detection kits. As a strategic technology partner, Agena is comparable in the nucleic acid mass spectrometry segment and represents both an upstream technology provider and a downstream competitive force in this niche modality.

Broad incumbents

• QIAGEN: QIAGEN is a global molecular diagnostics and sample technologies leader providing PCR, NGS, and sample preparation solutions for oncology and infectious disease. It overlaps with SpaceGen in the broader molecular diagnostics space (sample prep, PCR reagents, NGS panels) but as a global incumbent with broader portfolio and regulatory reach.
• KingMed Diagnostics: KingMed Diagnostics is China's largest independent third-party medical testing laboratory network. Comparable to SpaceGen's MedLab subsidiaries in providing clinical molecular diagnostic testing services, with significantly broader geographic coverage and test menu depth, but a less oncology-focused product strategy.
• BGI Genomics: BGI Genomics is China's largest genomics company with broad operations across reproductive health, oncology, infectious disease, and agricultural genomics. While not exclusively focused on oncology, BGI competes broadly with SpaceGen in molecular diagnostics, sequencing services, and reagent manufacturing, and operates its own sequencing platform (MGISEQ) compatible with some SpaceGen products.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries2 records

Funding overview

Funding rounds2 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SpaceGen