What Guangzhou Darui Biotechnology does

Guangzhou Darui Biotechnology Co., Ltd. (广州市达瑞生物技术股份有限公司) is a Chinese in-vitro diagnostic (IVD) company founded in 2003 and headquartered in Guangzhou Science City. It is a subsidiary of DAAN Gene Co., Ltd. of Sun Yat-sen University (Shenzhen Stock Exchange 002030) and is independently listed on the National Equities Exchange and Quotations (NEEQ / New Third Board) under stock code 832705 since July 2015. The company operates eight core diagnostic technology platforms — time-of-flight mass spectrometry (DR MassARRAY), next-generation sequencing (DA8600), time-resolved fluoroimmunoassay (DR6660), chemiluminescence immunoassay (DR-CL2000), tandem mass spectrometry (DR TQ MASS), CD-DST tumor drug sensitivity testing (DR6690), gene chip (Affymetrix GCS 3000Dx v.2), and Sanger sequencing (ABI 3500 DX) — supported by a reagent catalog covering prenatal screening, tumor markers, hormones, infectious disease, and diabetes testing, with 144 registered medical device certificates and 28 national patents.

The company serves domestic hospitals at all administrative levels and professional testing institutions across all 34 provincial-level regions of mainland China through an independent direct sales force and the parent DAAN Gene's distribution system, with additional export activity in the US, Japan, UK, and Switzerland. Revenue is generated through one-time sales of IVD reagents, hardware sales and service for diagnostic instruments, and professional medical testing services including prenatal screening, newborn screening, tumor screening, and infectious disease testing. Key customers are healthcare providers; primary use cases are prenatal and newborn health, oncology diagnostics (tumor screening and personalized medication guidance), and infectious disease testing (including COVID-19 ELISA and colloidal gold kits). Pricing is not publicly disclosed and products are regulated as Class III medical devices.

The company holds ISO 13485:2016, ISO 15189, CAP, and CE certifications, and has received the National Science and Technology Progress Award (Second Prize, 2017) plus multiple Guangdong Province innovation recognitions. It maintains academic research collaborations with Southern Medical University, Sun Yat-sen University, and Fudan University, and technology partnerships with international firms including Agena Bioscience, Thermo Fisher Scientific, Kurabo Industries, Waters, and AB SCIEX. In 2023 it received NMPA approval for the nation's first mass spectrometry-based deafness gene detection kit, and in late 2022 it launched 17 new chemiluminescence immunoassay reagent products, signaling continued platform and menu expansion.

Name

Guangzhou Darui Biotechnology

Legal name

广州市达瑞生物技术股份有限公司

Website

https://daruibiotech.com

Company type

Private

Founded year

2003

Operating status

Operating

Short description

Guangzhou Darui Biotechnology is a Chinese in-vitro diagnostic company operating eight diagnostic technology platforms (mass spectrometry, NGS, chemiluminescence, time-resolved fluorescence) and selling IVD reagents, instruments, and testing services to hospitals and clinical labs across all 34 Chinese provinces, with international exports to the US, Japan, UK, and Switzerland.

Ownership category

akta.pro rank

Product category

In-vitro Diagnostics (IVD)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (62151), Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

Keywords

• In-vitro diagnostics
• Clinical diagnostic reagents
• Molecular diagnostic platforms
• Prenatal genetic screening
• Mass spectrometry diagnostics

Headquarters

HQ city

Guangzhou

HQ country

China

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. In-vitro Diagnostic (IVD) Reagent Sales: Sale of diagnostic reagents for various platforms including time-resolved fluorescence, chemiluminescence, ELISA, and colloidal gold. Products include tumor markers, hormones, infectious disease tests, prenatal screening, and diabetes tests. The company holds 144 registered medical device certificates and CE/CFDA certifications.
2. Medical Instrument Sales and Service: Sale and service of diagnostic instruments including DR MassARRAY, DA8600 sequencer, DR6660 time-resolved analyzer, DR-CL2000 chemiluminescence analyzer, and gene sequencing platforms.
3. Medical Testing Services: 提供医学检测服务，包括产前筛查、新生儿筛查、肿瘤筛查及肿瘤个体化用药指导、传染病检测、激素检测等

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

Guangzhou Darui Biotechnology develops, manufactures, and sells in-vitro diagnostic (IVD) instruments and reagents across eight core technology platforms, including time-of-flight mass spectrometry, next-generation sequencing, chemiluminescence immunoassay, time-resolved fluoroimmunoassay, tandem mass spectrometry, ELISA, immune colloidal gold, and CD-DST tumor drug sensitivity. The company provides diagnostic products for prenatal screening, newborn screening, tumor diagnostics, infectious disease testing (including COVID-19), and hormone testing to hospitals at all administrative levels and professional testing institutions across China, complemented by medical testing services.

Product overview

Guangzhou Darui Biotechnology operates as a multi-platform in vitro diagnostic (IVD) company offering a portfolio of diagnostic technology platforms and reagent products. The core product architecture comprises eight technology platforms: (1) DR MassARRAY — a time-of-flight mass spectrometry (TOF MS) platform for nucleic acid detection, (2) DA8600 — a high-throughput next-generation sequencing (NGS) platform, (3) DR6660 — a time-resolved fluorescence immunoassay platform, (4) DR-CL2000 — a fully automated chemiluminescence immunoassay platform, (5) DR TQ MASS — a tandem mass spectrometry platform, (6) DR6690 — a tumor drug sensitivity (CD-DST) platform, (7) Affymetrix GCS 3000Dx v.2 — a gene chip platform, and (8) ABI 3500 DX — a first-generation Sanger sequencing platform. These platforms are supported by an extensive reagent catalog covering prenatal screening, tumor markers, infectious diseases, hormones, genetic testing, and inherited metabolic diseases. The company additionally offers COVID-19 diagnostic products including antibody detection kits (ELISA and colloidal gold formats) and sample collection/preparation reagents. The product portfolio is distributed nationally across 34 provincial-level administrative regions.

Differentiator

Problem solved

Functional benefit

Products and services

• DR MassARRAY Time-of-Flight Mass Spectrometry Detection System (DR MassARRAY飞行时间质谱检测系统) An automated medium-throughput genetic testing system based on US Agena's MassARRAY time-of-flight mass spectrometry technology, developed and manufactured domestically in China. Designed for hospitals and clinical testing centers for nucleic acid detection. The first mass spectrometer in China capable of directly detecting nucleic acids.
• DA8600 High-Throughput Gene Sequencer (DA8600高通量基因测序仪) High-throughput next-generation gene sequencer based on Thermo Fisher's semiconductor sequencing technology, domestically developed and manufactured. Widely applicable in clinical testing centers of medical institutions. Registered with NMPA in 2014.
• DR6660 Time-Resolved Fluorescence Immunoassay Platform (DR6660时间分辨技术平台) Plate-based time-resolved immunofluorescence analysis platform using solid-phase microplate-coated antigens/antibodies with lanthanide rare earth element chelates as labels for qualitative and quantitative analysis. Represents internationally advanced immunoassay technology.
• DR-CL2000 Fully Automated Chemiluminescence Immunoassay Analyzer (DR-CL2000全自动化学发光免疫分析仪) Fully automated chemiluminescence immunoassay analyzer using magnetic beads for purification and separation with acridinium ester as signal label. Detection speed reaches 200 tests per hour. Applied in tumor markers, hormones, infectious disease, prenatal screening, and diabetes testing.
• DR TQ MASS Tandem Mass Spectrometry Platform (DR TQ MASS串联质谱平台) Tandem mass spectrometry platform with leading domestic technical level, focused on precision medicine applications including prenatal/prenatal health screening and tumor detection products.
• DR6690 Tumor Drug Sensitivity Platform (CD-DST) (DR6690肿瘤药敏平台) Tumor drug sensitivity platform using primary tumor cell three-dimensional culture technology to simulate the in vivo tumor cell microenvironment and construct in vitro drug sensitivity testing cell models. Achieves tumor cell extraction and culture success rate of 90% or above.
• Affymetrix GCS 3000Dx v.2 Gene Chip Platform Gene chip platform leveraging Affymetrix GCS 3000Dx v.2 chip system and Agilent SureScan Dx microarray chip scanning system for human whole-genome copy number detection and SNP analysis.
• ABI 3500 DX First-Generation Sanger Sequencing Platform First-generation sequencer using Sanger sequencing (dideoxy chain termination) principle, with capillary electrophoresis for sequence analysis of fluorescence-labeled PCR products.
• SARS-CoV-2 IgG Antibody Detection Kit (ELISA) Qualitative detection of SARS-CoV-2 IgG antibodies in human serum or plasma. 94 tests per 1.5 hours. German registration number DE/CA09/0170/G19/IVD/001.
• SARS-CoV-2 IgM Antibody Detection Kit (ELISA) Qualitative detection of SARS-CoV-2 IgM antibodies in human serum or plasma. 94 tests per 1.5 hours.
• SARS-CoV-2 IgG Antibody Detection Kit (Colloidal Gold) Qualitative detection of SARS-CoV-2 IgG antibodies in human serum, plasma, or whole blood. Results obtained within 20 minutes.
• SARS-CoV-2 IgM Antibody Detection Kit (Colloidal Gold) Qualitative detection of SARS-CoV-2 IgM antibodies in human serum, plasma, or whole blood. Results obtained within 20 minutes.
• First Mass Spectrometry-Based Deafness Gene Detection Reagent Kit (全国首个基于质谱技术的耳聋基因检测试剂盒) China's first mass spectrometry-based deafness gene detection reagent kit. Applied on the DR MassARRAY time-of-flight mass spectrometry platform for clinical deafness gene screening.

Quantifiable outcome

• Tumor cell extraction and culture success rate of 90% or above when tissue samples meet requirements
• +1 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Eight partnerships are on record, tiered important, core and minor.

• Kina Biotech (Shanghai) Co., Ltd. (基纳生物技术（上海）有限公司)importantChannel Partner/ Reseller/ Distributor · 17 January 2019Strategic partner for nucleic acid mass spectrometry platform sales and market development. Kina Biotech provides sales support and service upgrades for the mass spectrometry platform, collaborating on the new mass spectrometry era in clinical diagnostics.
• Daan Gene Co., Ltd. (达安基因股份有限公司)coreStrategic or Co-development PartnerParent company and strategic partner. Daan Gene is a state-owned biotech enterprise listed on Shenzhen Stock Exchange (stock code 002030) with market value over $1.2 billion USD. It has four research institutes and seven holding companies, providing strong backing for Darui's development through technology transfer, sales network leverage, and strategic resources.
• Southern Medical University (南方医科大学)importantStrategic or Co-development PartnerAcademic research collaboration for diagnostic technology development and talent recruitment. Key personnel including Professor Wu Yingsong serve as doctoral supervisors and contribute to R&D projects.
• Sun Yat-sen University (中山大学)importantStrategic or Co-development PartnerCore academic partner providing technology transfer and clinical collaboration. Professor He Yunshao serves as director of Ministry of Health Medical Biological Engineering Technology Research Center.
• Fudan University (复旦大学)minorStrategic or Co-development PartnerAcademic research collaboration partner for tandem mass spectrometry platform development.
• Kurabo Industries Ltd. (日本兴亚)importantStrategic or Co-development PartnerStrategic cooperation established in 2013 to introduce primary tumor cell 3D culture drug sensitivity testing (CD-DST technology) for Chinese clinical applications. Technology transfer and clinical collaboration partnership.
• Thermo Fisher ScientificimportantTechnology or IntegrationTechnology introduction partner for DA8600 high-throughput gene sequencer. Thermo Fisher's semiconductor sequencing technology integrated into domestically developed clinical sequencer.
• Agena BioscienceimportantTechnology or IntegrationTechnology introduction for MassARRAY time-of-flight mass spectrometry platform. US-based technology partner for nucleic acid mass spectrometry systems.

Scale indicators5 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• YHLO Biotech: Shenzhen-based chemiluminescence and clinical immunology IVD company with overlapping reagent menu in tumor markers, hormones and infectious disease — directly competes with Darui's CLIA line.
• BGI Genomics: Shenzhen-listed Chinese genetic sequencing leader, the dominant domestic competitor in NIPT/prenatal screening, newborn genetic screening and clinical NGS — directly overlapping Darui's highest-priority segment.
• Snibe (Shenzhen New Industries Biomedical Engineering): Leading Chinese chemiluminescence immunoassay platform company; directly comparable to Darui's DR-CL2000 chemiluminescence franchise and infectious disease/tumor marker menu.
• Annoroad Gene Tech: Beijing-based genetic sequencing and clinical diagnostics company with prenatal, oncology and NIPT offerings; competes with Darui's NGS and prenatal screening platform across hospital channels.
• KingMed Diagnostics: China's largest third-party medical testing laboratory chain; comparable via the medical-testing-services revenue stream Darui also operates, plus shared end-customers in hospitals.
• Maccura Biotechnology: Sichuan-based IVD reagent and instrument maker across clinical chemistry, immunoassay, hematology and molecular diagnostics; competes in the same hospital procurement channels as Darui.
• Autobio Diagnostics: Major Chinese IVD manufacturer with a multi-platform reagent and instrument portfolio (chemiluminescence, ELISA, microbiology); broader scale but directly comparable product mix to Darui's eight-platform approach.
• Shanghai Kehua Bio-engineering: Long-established domestic IVD manufacturer across clinical chemistry, immunoassay and molecular diagnostics; competes with Darui in conventional IVD reagent distribution to Chinese hospitals.
• Berry Genomics: Beijing-based clinical NIPT and prenatal genetic testing company; competes head-on with Darui in prenatal and reproductive health diagnostics on reagents and sequencing services.

Broad incumbents

• Mindray: Largest Chinese medical device company, with IVD (chemiluminescence, hematology, microbiology) as one of several large segments; broader portfolio but overlaps directly with Darui's instrument+reagent strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

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

M&A

Investments1 record

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

Frequently asked questions about Guangzhou Darui Biotechnology