What Wondfo does

Wondfo Biotech Co., Ltd. (Shenzhen Stock Exchange: 300482.SZ) is a China-based, publicly listed in-vitro diagnostics (IVD) company founded in 1992 and headquartered in Guangzhou Science City, operating across nine integrated technology platforms — colloidal gold, immunofluorescence (Finecare), chemiluminescence (ACCRE/SmarLumi), coagulation, blood gas, molecular diagnostics (U-CardDx 200), pathology (PA-3600 IHC), HPLC hemoglobin, and electrochemistry. Its portfolio spans rapid point-of-care testing (POCT) instruments and reagents for infectious disease (HIV, malaria, dengue, COVID-19, Mpox), chronic disease management (cardiac markers, HbA1c, coagulation), oncology and pathology, drug-of-abuse testing, and consumer diagnostics, with first-in-class products including the world's first optical coagulation analyzer testing PT/APTT/TT/FIB/ACT simultaneously and a 15-minute molecular POCT workflow.

The company monetizes primarily through sale of analyzers and recurring reagent consumables across an installed base of professional healthcare customers, supplemented by consumer-grade test kits (WELLlife COVID-19/Flu, SAFElife Fentanyl) via U.S. e-commerce and pharmacy channels, and by global public-health procurement of WHO-prequalified HIV and malaria products. Go-to-market combines 20+ wholly-owned subsidiaries (recent additions: Russia April 2025, Philippines April 2025, Malaysia July 2025), a distributor network spanning 150+ countries, and localized manufacturing partnerships in Uganda and Nigeria. R&D intensity is high at RMB 438 million in 2024 (14.3% of revenue), and the company maintains regulatory moats including WHO prequalification, IVDR CE certification, FDA 510(k)/EUA approvals, IFCC membership, and 12 items on the JCTLM Reference Measurement Services list.

FY2024 revenue was RMB 3.065 billion (~USD 420 million, +10.85% YoY) with net profit of RMB 562 million; FY2025 revenue fell to RMB 2.087 billion (~USD 287 million) with a net loss of RMB 63 million, reflecting industry-wide IVD demand normalization. Leadership includes Founder Wenmei Li and Chairwoman Jihua Wang, with President Zhongxiong Peng, VP/Head of International Sales & Marketing Mark Xu, and General Manager of Wondfo Health Yunping Peng. The balance sheet remains conservative, with RMB 1.971 billion in cash and trading financial assets and an ~17% asset-liability ratio as of Q1 2026.

Name

Wondfo

Legal name

WONDFO BIOTECH CO., LTD.

Website

https://en.wondfo.com

Company type

Public

Founded year

1992

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Wondfo is a publicly listed Chinese IVD company operating 9 POCT technology platforms — colloidal gold, immunofluorescence, chemiluminescence, coagulation, blood gas, molecular, pathology, HPLC, and electrochemistry — serving hospitals, public-health programs, and consumers in 150+ countries.

Ownership category

akta.pro rank

Headquarters

HQ city

Guangzhou Shi

HQ country

China

HQ region

Asia

Offices7 records

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. POCT Instruments and Reagents: Wondfo generates revenue primarily from selling rapid diagnostic devices (analyzers) and associated reagent kits across its 9 technology platforms. The company derives recurring revenue from reagent consumption across installed instrument bases. Key product categories include immunofluorescence analyzers (Finecare series), chemiluminescence analyzers (ACCRE, SmarLumi), blood gas analyzers, coagulation analyzers, molecular diagnostic systems, and pathology staining systems.
2. Consumer/Direct-to-Consumer Diagnostics: Revenue from consumer-grade diagnostic products sold via e-commerce and pharmacy channels, including the FDA-approved WELLlife™ COVID-19/Flu A&B Home Test and SAFElife™ Fentanyl Urine Test in the U.S. market.
3. Public Health and Government Procurement: Revenue from inclusion of colloidal gold public health products in national procurement guidelines, and WHO prequalified products (HIV, Malaria) procured by global health organizations.
4. Local Manufacturing and Technology Transfer: Revenue from localized production partnerships including plants in Uganda (Microhaem Scientifics), Nigeria (PVAC agreement), and other developing countries, where Wondfo provides technical assistance and manufacturing know-how for local production of diagnostic reagents.

Go-to-market motion4 records

Distribution channels6 records

Marketing channels9 records

Core offering

Wondfo develops and manufactures in vitro diagnostic (IVD) devices and reagents organized around nine proprietary technology platforms — Colloidal Gold, Immunofluorescence (Finecare), Chemiluminescence (ACCRE/SmarLumi), Coagulation, Blood Gas, Molecular Diagnostics, Pathology, HPLC Hemoglobin, and Electrochemistry — for point-of-care testing across infectious disease, cardiovascular, diabetes, oncology, fertility, drug-of-abuse, and chronic disease applications. The company also sells FDA-cleared consumer diagnostics (WELLlife COVID-19/Flu Home Test, SAFElife Fentanyl Test) in North America, and partners with global health programs for WHO-prequalified HIV and Malaria tests. Revenue is generated through instrument sales, recurring reagent consumption, government and WHO procurement, technology transfer/licensing for local production, and B2C retail sales.

Product overview

Wondfo Biotech is a leading POCT (Point-of-Care Testing) company specializing in the IVD (In Vitro Diagnostics) industry. Founded in 1992 and headquartered in Guangzhou Science City, the company offers a comprehensive portfolio organized around 9 technology platforms: Colloidal Gold, Immunofluorescence (Finecare), Chemiluminescence (ACCRE/SmarLumi), Coagulation, Blood Gas (BGA-102/Ucare-6000), Molecular Diagnostics (U-CardDx 200, RT-PCR), Pathology (PA-3600 IHC Staining System), HPLC Hemoglobin (Truth-H80E), and Electrochemistry. The product portfolio includes rapid diagnostic devices and reagents spanning cardiovascular diseases, diabetes, renal functions, respiratory issues, fertility, drug abuse, infections, tumors, and more. Key instruments include the SmarLumi FC-2100, Accre series (8/90/120), Finecare FIA platforms (FS-1000/FS-2000), U-CardDx 200 molecular diagnostics, and PA-3600 pathology system. The company provides solutions for clinical diagnostics, public health, chronic disease management, and consumer/home diagnostics, serving over 150 countries and regions worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• Finecare: Immunofluorescence platform for rapid diagnostics including cardiovascular disease, inflammation, kidney injury, and other markers
• SmarLumi
• ACCRE
• Ucare
• WELLlife
• SAFElife
• U-CardDx
• WonNova
• Truth-H80E
• PA-3600

Products and services

• Colloidal Gold Platform Equipment-free rapid immunochromatographic diagnostic platform used for infectious disease (HIV, malaria, dengue), fertility, and drug-of-abuse testing in clinical, public health, and consumer settings.
• Immunofluorescence (Finecare) Platform Quantitative fluorescence immunoassay platform with 50+ reagents and seven high-performance analyzers (FS-1000, FS-2000, FS-114, FS-2100) for cardiovascular, inflammation, kidney injury, sex hormone, thyroid, diabetes, and tumor markers at point-of-care.
• Chemiluminescence (ACCRE / SmarLumi) Platform Single-dose chemiluminescence immunoassay platform with maintenance-free operation, carry-over prevention, 600-day MTBF, and nearly 100 testing parameters covering tumor markers, thyroid, cardiac, inflammation, coagulation, and chronic disease markers.
• Coagulation Platform (Optical Blood Coagulation Analyzer) Optical blood coagulation analyzer testing PT, APTT, TT, FIB, and ACT simultaneously — the first of its kind in the world — plus a Thrombosis 4-Item Test (TAT, TM, PIC, t-PAIC) for early thrombosis screening.
• Blood Gas Platform (BGA-102 / Ucare-6000) Blood gas analyzer for emergency, ICU, and laboratory use. BGA-102 delivers results in 30 seconds; Ucare-6000 features an all-in-one reagent pack with automated calibration and IQC for full-panel results in one step.
• U-CardDx 200 Molecular POCT System Microfluidics-based molecular point-of-care solution using magnetic bead nucleic acid extraction and real-time qPCR with lyophilized ready-to-use reagents; delivers a full workflow in 15 minutes with 200 copies/mL sensitivity for infectious disease testing.
• WonNova 1600 Fully Automated Nucleic Acid Extraction and Real-Time PCR System Fully automated nucleic acid extraction and real-time PCR system for molecular diagnostics, targeting centralized laboratory use with NMPA approval.
• PA-3600 IHC Staining System (Pathology Platform) Fully automated immunohistochemistry staining system with patented per-slide temperature control, solid-liquid cover technology, wavelike-mixing technology, RFID chip recognition, and ultra-sensitive HRP enzyme-conjugated 'clover-like' secondary antibodies; supports IHC, ISH, and FISH applications.
• Truth-H80E HPLC Hemoglobin Analyzer HPLC-based analyzer for precise measurement of glycosylated hemoglobin (HbA1c) — the gold standard for diabetes diagnosis — with results in 60–90 seconds and a chromatography column usable up to 2,000 times.
• SmarLumi FC-2100 Chemiluminescence Immunoassay Analyzer Fully-automatic bench-top chemiluminescence immunoassay analyzer with 0.64 sqm footprint, 60 sample positions, 25 reagent positions, 200 tests/hour throughput, and first results in 12 minutes for hospital laboratories.
• Accre 120 Automatic Chemiluminescence Immunoassay Analyzer Bench-top automatic chemiluminescence immunoassay analyzer with single-dose reagent cartridge, maintenance-free design, 600-day MTBF, and compact footprint (570x685x740mm, 100kg) for mid-volume laboratories.
• Accre 90 Automatic Chemiluminescence Immunoassay Analyzer Compact bench-top automatic chemiluminescence immunoassay analyzer with single-dose reagent cartridge, up to 96 tests/hour, and 600-day MTBF (566x524x672mm, 67kg).
• Accre 8 Compact Chemiluminescence Immunoassay Analyzer Compact automatic bench-top CLIA analyzer with single-dose reagent cartridge, up to 36 tests/hour, 12–40 minute TAT, and a footprint 70% smaller than ordinary CLIA analyzers for low-volume point-of-care settings.
• FS-1000 Fluorescence Immunoassay Analyzer Upgraded fluorescence immunoassay analyzer with one-step barcode scanning, whole-blood one-step sample addition, built-in lithium battery with 12-hour standby, and high-sensitivity cardiac troponin I results in 8 minutes.
• FS-2000 Fluorescence Immunoassay Analyzer Multi-channel fluorescence immunoassay analyzer with enhanced specificity, improved stability, and rapid testing mode for urgent diagnostic needs in clinical and emergency settings.
• WELLlife COVID-19/Flu A&B Home Test FDA EUA- and 510(k)-cleared at-home rapid antigen test for COVID-19 and Influenza A&B, sold via e-commerce and pharmacy channels in North America.
• SAFElife Fentanyl Urine Test FDA 510(k)-cleared urine test for fentanyl detection, sold through U.S. e-commerce and pharmacy channels as part of Wondfo's drug-of-abuse consumer diagnostics line.
• Malaria P.f (HRP2/pLDH) Test Colloidal gold immunochromatographic test for qualitative detection of Plasmodium falciparum HRP2 and pLDH antigens in whole blood; WHO-prequalified for global public health procurement.
• One Step HIV Self-Testing Kit WHO-prequalified single-use HIV self-testing kit using finger-stick whole blood with results in 15 minutes, distributed through public health programs and global procurement channels.
• Mpox (Monkeypox) Virus Real-Time PCR Assay and U-Card Dx Mpox Test PCR-based nucleic acid detection assays for Monkeypox virus from skin lesion tissues, throat swabs, whole blood, and serum, supporting outbreak surveillance and clinical diagnosis.
• Dengue Virus Testing Reagents Combined dengue virus antigen and antibody rapid test for quick determination of dengue infection status and disease progression, used in clinical and public health settings in endemic regions.
• Thrombosis 4-Item Test (TAT, TM, PIC, t-PAIC) Early screening panel for thrombosis combining TAT, TM, PIC, and t-PAIC markers, run on the Wondfo coagulation platform for VTE prevention and emergency diagnostics.
• Finecare hs-cTnI (High-Sensitivity Cardiac Troponin I) Test High-sensitivity cardiac troponin I test for Finecare analyzers with detection limit as low as 20 pg/mL and 8-minute results, supporting rapid rule-in/rule-out of myocardial infarction in emergency departments.
• Finecare Vitamin D Test Quantitative Finecare platform-based Vitamin D test for nutritional assessment and primary care support, designed to simplify vitamin D status measurement.

Quantifiable outcome

• R&D investment of RMB 438 million (14.3% of revenue) in 2024, launching 82 new products (75 reagents, 7 devices)
• +4 more outcomes

Named customers9 records

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature8 records

Partnerships

14 partnerships are on record, tiered core and minor.

• Shanghai Kinbio Biotech Co., Ltd.coreStrategic or Co-development Partner · 2 July 2025Wondfo and Kinbio signed a strategic cooperation agreement for global localized production of rapid diagnostic reagents. The partnership integrates Wondfo's biotechnology expertise with Kinbio's IVD production line automation capabilities to provide international partners with one-stop production and distribution solutions.
• Vestergaard, Abbott, Siemens Healthineers, ZiplinecoreStrategic or Co-development PartnerWondfo was among the global pharmaceutical and diagnostic companies that signed at least 10 strategic MoUs with the Nigerian government following federal policies introduced in 2023 after multinational pharma exits. These partnerships aim to strengthen Nigeria's pharmaceutical sector and support local manufacturing of diagnostic products.
• MedAccesscoreStrategic or Co-development PartnerMedAccess, a non-profit focused on enhancing medical product accessibility in low and middle-income countries, partnered with Wondfo (along with CHAI) to provide HIV self-testing products for low-income regions in Africa. Discussions are ongoing for malaria product cooperation following WHO PQ certification of Wondfo's malaria test.
• Côte d'Ivoire Ministry of HealthcoreStrategic or Co-development PartnerWondfo hosted the Conference on Evaluation Results of Rapid Diagnostic Tests in Côte d'Ivoire, bringing together laboratory experts and public health professionals from West African countries. Wondfo signed a strategic agreement with Côte d'Ivoire's Ministry of Health for future local technology transfer, cooperating in Industry–Academia–Research–Application to expand access to high-quality diagnostic products across ECOWAS.
• UNECA Healthcare Center and African Union CommissioncoreStrategic or Co-development PartnerDelegations from the United Nations Economic Commission for Africa (UNECA) and African Union Commission visited Wondfo to learn about innovative IVD practices. UNECA Healthcare Center has already introduced Wondfo's quantitative fluorescence system for cardiac marker testing, with the lab now having six installations. Both organizations aim to upgrade healthcare services in African countries using Wondfo's advanced experiences and technologies.
• Universiti Sains Malaysia (USM)minorStrategic or Co-development PartnerWondfo signed an MOU with Universiti Sains Malaysia (USM), a top-tier university ranked in the top 1% globally, to strengthen collaboration in academic exchanges and accelerate the transformation of scientific research achievements. Wondfo and USM will collaborate on clinical research projects, joint product development, and educational innovation. Wondfo had already begun scientific research cooperation with USM in 2022 on POCT applications in critical care.
• Uganda Ministry of Health and Kampala Capital City Authority (KCCA)coreStrategic or Co-development PartnerWondfo launched a pioneering HIV self-testing campaign in partnership with Uganda's Ministry of Health and KCCA, targeting bodaboda riders and market vendors. The campaign distributes user-friendly, single-use test kits providing results in 15 minutes, along with counseling services and educational resources delivered directly to urban communities via audiovisual trucks and on-the-ground teams.
• International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)coreStrategic or Co-development PartnerWondfo became an official member of IFCC in 2024, committed to enhancing communication with international experts and participating in the research and development of international standards to contribute to global laboratory medicine standardization. Wondfo's Reference Systems Department promotes measurement traceability from SI reference laboratories to clinical laboratories.
• University of Technology Malaysia (UTM)minorStrategic or Co-development PartnerUTM conducted a clinical study validating Wondfo's quantitative Fluorescence Detection System for PCT testing in sepsis ICU patients. The study, published in the journal Diagnostics, showed a correlation coefficient of 0.98 between Wondfo's system and the world's leading biochemical immunoassay system, demonstrating robust performance for critically ill sepsis monitoring.
• Clinton Health Access Initiative (CHAI)coreStrategic or Co-development PartnerCHAI partnered with Wondfo and MedAccess in 2022 to provide HIV self-testing products for low-income regions, benefiting a wider population and actively supporting global AIDS prevention efforts across Africa.
• Nigerian Presidential Initiative on Healthcare Value Chain (PVAC)coreStrategic or Co-development PartnerWondfo signed a cooperation agreement with the Nigerian Presidential Initiative on Healthcare Value Chain (PVAC) in August 2024. The Nigerian government provides policy, financial, and infrastructure support to facilitate local production of Wondfo's diagnostic reagents, enhancing Wondfo's supply chain resilience across Africa.
• Microhaem Scientifics (Uganda)coreStrategic or Co-development PartnerWondfo provided full technical assistance for the establishment of the Uganda Diagnostic Reagent Manufacturing Plant, Microhaem Scientifics, inaugurated in November 2023. The plant benefits over 300 million people and serves as a model for Wondfo's localized production strategy in Africa.
• European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)minorStrategic or Co-development PartnerWondfo served as Silver Partner at the EFLM Strategic Conference 2026 in Prague, strengthening engagement with the global laboratory medicine community. Discussions covered testing efficiency, decentralized diagnostics, and emerging clinical applications.
• European, Middle Eastern, and Other International Partners (Molecular Diagnostics)minorStrategic or Co-development PartnerDuring ESCMID 2026, Wondfo entered into strategic cooperation agreements with partners across Europe, the Middle East, and other regions to strengthen its position in the global molecular diagnostics market and support the commercialization of the U-CardDx 200 molecular POCT system.

Scale indicators16 records

Recent moves10 records

Expansion highlights6 records

Broad incumbents

• QuidelOrtho: US-based IVD company with strong rapid diagnostics franchise (Sofia, Triage, QuickVue) plus a broader clinical chemistry and immunoassay business — comparable to Wondfo in rapid infectious disease and cardiac marker POCT.
• Abbott Diagnostics: Global diagnostics leader with the broadest IVD and POCT portfolio (including former Alere assets) spanning immunoassay, molecular, blood gas, and consumer diagnostics — competes head-to-head with Wondfo across most platform categories.
• Hologic: US diagnostics and women's health specialist with molecular diagnostics (Panther), cytology/HPV testing, and rapid antigen tests — comparable to Wondfo in molecular POCT and select women's health/oncology adjacencies.
• Bio-Rad Laboratories: Diversified life science and clinical diagnostics company with quality controls, blood bank reagents, and digital PCR — overlaps with Wondfo's molecular diagnostics and laboratory QC/reference measurement services.
• Siemens Healthineers: Major global diagnostics and imaging incumbent with significant POCT and immunoassay presence (Atellica, epoc) — directly competes with Wondfo in chemiluminescence, blood gas, and immunochemistry hospital segments.
• Roche Diagnostics: World's largest IVD player with extensive central-lab and POCT offerings across immunoassay, clinical chemistry, molecular diagnostics, and coagulation — overlaps with Wondfo's chemiluminescence, coagulation, and molecular diagnostics lines.

Direct peers

• Acon Laboratories: US-headquartered IVD and POCT company with a comparable portfolio of rapid diagnostic tests across infectious disease, fertility, drugs of abuse, and clinical chemistry — overlapping directly with Wondfo's colloidal gold and consumer diagnostic lines.
• Boditech Med: Korean POCT company focused on immunofluorescence and clinical chemistry analyzers with reagent menus spanning cardiovascular, inflammation, infectious disease, and hormones — directly comparable to Wondfo's Finecare platform.
• SD Biosensor: Korean IVD/POCT specialist with strong overlap in immunofluorescence, rapid antigen tests, and infectious disease diagnostics — a close product-line competitor to Wondfo, especially in Africa and Southeast Asia.
• Sinocare Inc. China-based IVD/POCT competitor with leadership in blood glucose monitoring and a growing portfolio in infectious disease and chronic disease diagnostics — overlaps with Wondfo's domestic Chinese POCT positioning and consumer health (Wondfo Health) initiatives.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/wondfobiotech
• YouTubeyoutube.com/channel/UCiJc9BlYVbtsHNoxLkupWYA
• Facebookfacebook.com/WondfoOfficial
• LinkedInlinkedin.com/company/wondfo
• Instagraminstagram.com/wondfo.biotech

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries6 records

Funding overview

Funding rounds

Investors

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 Wondfo