List of Diagnostics Companies in China - 30

Amoy Diagnostics (AmoyDx) is a visionary diagnostic company dedicated to transforming the landscape of cancer care. 'Breaking Barriers to Precision Oncology' reflects our commitment to revolutionizing cancer diagnosis and treatment. We are driven by four fundamental values: Innovation in Care, Accessibility and Equity, Collaboration and Partnership, and Integrity and Trust. These values guide our pursuit of developing groundbreaking diagnostic tools and fostering a more equitable, collaborative, and trustworthy approach to oncology. Join us as we pave the way to a future where precision cancer care is a reality for every patient, everywhere.

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly infectious diseases and cancers (including orphan oncology indications). The company is also pursuing therapeutic and diagnostic projects in neurology, gastroenterology, metabolic disorders, women's health and other disease areas. The company also has a non-therapeutics division focused on the development of surgical robotics and medical devices.

China National Pharmaceutical Group Corporation, SINOPHARM, is the largest pharmaceutical and healthcare group under State-Owned Assets Supervision and Administration Commission of the State Council (SASAC) in China, with core business of pharmaceutical distribution, scientific research and manufacture of medical and biotech products. The group has 16 wholly-owned subsidiaries and holding companies, one H-share listed company, Sinopharm Group Co., Ltd., and four A-share listed companies, China National Medicines Co., Ltd. (CNCM), Beijing Tiantan Biological Products Co., Ltd. (TiantanBio), Shyndec Pharmaceutical Co., Ltd. (Shyndec) and Shenzhen Accord Pharmaceutical Co., Ltd. (Accord). In 2009, the group's revenue had reached 65 billion Yuan. Among the 129 central enterprises, SINOPHARM is ranked 50th and 38th in terms of revenue and total profit respectively. In 2010, SINOPHARM's revenue is estimated to be 80 billion Yuan. SINOPHARM is the president unit of CPIA, CNNDA, CAPC, Sino-PhRDA, CAMDI, CATCM and CPCS etc., and also the sponsor and supporter of many important exhibitions including PHARMCHINA.

Kewei's products include the diagnostic kits of hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B 'e' antigen, hepatitis B 'e' antibody and hepatitis B core antibody, hepatitis a virus IgM diagnostic kits, hepatitis E virus IgM diagnostic kits, RPR diagnostic kits, HBV test cassettes, HIV Ag/Ab diagnostic kits, etc.

Berry Oncology, founded in 2017 as a member company of Berry Genomics, focuses on genomic testing of cancers.

BioTeke Corporation is a provider of molecular diagnostics instrument & related reagents. built at 2005, headquarter locates in Beijing, and factory in Wuxi city. We offer kinds of lab instruments as: Automated nucleic acid extraction system; UV-Vis spectrophotometer; 96 Gradient PCR; Centrifuge; Tip Rack Refill system; Automated liquid handling system; Gel imaging system And we also provide more than 100 kinds of DNA/RNA/Protein extraction reagents. Bioteke holds the philosophy to offer quick molecular diagnostic products with low price,high quality and superior services to the world.

Bivision is a China-based biopharmaceutical company that develops visually targeted radionuclide therapies for the treatment of cancer across the globe.

About Burning Rock Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of： 1) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 273,000 tissue and liquid-based tests completed cumulatively. 2) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage. In July 2018, Burning Rock received the first approval for a tumor NGS kit by the National Medical Products Administration (NMPA), which is a significant milestone in the field of in vitro diagnosis in China. Burning Rock’s laboratory has obtained the technical certification of “High-throughput sequencing laboratory” issued by Guangdong Center for Clinical Laboratory, and the CLIA and CAP laboratory quality system certification. The company continues to be committed to the development of innovative and reliable NGS testing products and promoting the development of precision medicine in oncology. 燃石医学（纳斯达克代码：BNR）成立于2014年，公司使命为“用科学守护生命之光”，专注于为肿瘤精准医疗提供具有临床价值的二代基因测序（NGS）。公司业务及研发方向主要覆盖： 1）基于NGS的肿瘤患病人群检测，累计检测样本超过27万例，在中国拥有领先的市场份额； 2）基于NGS的癌症早检，目前已经进入临床验证阶段。 燃石医学于2018年7月获国家药品监督管理局（NMPA）颁发的中国肿瘤NGS检测试剂盒第一证，在体外诊断领域具有里程碑式意义。位于中国广州的实验室通过广东省临检中心颁发的“高通量测序实验室”技术审核，获得美国CLIA和CAP实验室质量体系资质认证；位于美国加利福尼亚州的实验室也已获得CLIA和CAP实验室质量体系资质认证。公司将继续致力于开发创新可靠的NGS检测产品，推动肿瘤精准医疗领域的发展。

DIAGENS is a Hangzhou-based biotechnology firm, providing in-vitro diagnostic (IVD) products and other medical equipment.

Eachy Biopharmaceuticals, Ltd is a ISO 13485 qualified company focused on developing and producing in vitro diagnostics for the prognosis of cardiovascular diseases, metabolic syndrome and the diagnosis of inflammatory diseases.AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) - EU CE Mark 32020

Fapon is a global leading life sciences company dedicated to providing integrated solutions and services for diagnostics, biopharma and biotherapy. Integrating a one-stop solution on raw materials, reagents and innovative open instrument platforms, the Company has grown into a leading supplier in in-vitro diagnostics. Fapon boasts advanced innovations in therapeutics technologies and AI algorithm platforms with data insights that contribute to a better and healthier world. Supported by its strong global R&D, manufacturing, sales and service network, Fapon's products have established presence in 68 countries and regions, serving more than 2,500 business partners worldwide.

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Fosun Pharma’s innovative products mainly covered core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease). Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of “Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets.

Genetron Holdings Limited ("Genetron Health" or the "Company") is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive product and service portfolio that cover the full-cycle of cancer care from early screening, to diagnosis and treatment recommendations, to continuous monitoring and continuous care.

3/28/24- the completion of its merger (the “Merger”) with Genetron New Co Limited (“Merger Sub”), pursuant to the previously announced agreement and plan of merger, dated as of October 11, 2023 (the “Merger Agreement”), among the Company, New Genetron Holding Limited (“Parent”) and Merger Sub. As a result of the Merger, the Company has become a wholly owned subsidiary of Parent and will cease to be a publicly traded company. Genetron Holdings Limited (“Genetron Health” or the “Company”) is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive product and service portfolio that cover the full-cycle of cancer care from early screening, to diagnosis and treatment recommendations, to continuous monitoring and continuous care.

Founded in 1992 and listed in 2015, Wondfo is a fast-growing biotechnology company in China. Wondfo mainly focuses on rapid diagnostics in China but is looking for further development in other areas of the healthcare industry. Besides the headquarter in Guangzhou, Wondfo also owns 2 overseas labs, 1 branch in Chicago, and 11 overseas offices. After many years’ efforts in delivering high-quality products and services, Wondfo has won a good reputation around the world. In production, Wondfo strictly complies with national and international regulations and standards. We have got CE certificates, FDA certificates, FSC certificates, ISO 9001:2008, and ISO 13485:2012 quality system certification. Wondfo attaches great importance to research and development and sees innovation as the soul of the enterprise’s development. So far, Wondfo has 530+ highly-qualified researchers and over 30% of the staff have obtained master's and doctorate degrees from prestigious universities worldwide. Wondfo also has built R&D laboratories in Guangzhou and San Diego. With our advanced production lines and highly experienced staff, Wondfo’s daily production capacity of test kits reaches 1.5 million. Wondfo also provides a number of customized services to professional distributors and partnering affiliates. Wondfo provides high-quality products at a very competitive price, together with professional technical support and counseling service. Currently, Wondfo has customers in more than 120 countries and areas. It is our commitment to safeguarding the health and improving lives with better products, services, and solutions. With more than 3000 dedicated employees, we'll continue to innovate and shape the future of POCT and healthcare.

Establish in 2008 in China Hangzhou city, Biotest is mainly engaged in the R&D, production and sales of in vitro diagnostic reagents, divided into 5 catagories: drug abuse testing, infectious desease testing, fertility health, tumor marker testing and cardiology market testing. E-mail: info-B@biotests.com.cn Nous sommes spécialisés dans la R&D, la production et la commercialisation des réactifs de laboratoire, surtout des tests de dépistage rapide depuis 14 ans et nous travaillons avec plus de 500 professionnels dans le domaine médical. Nous attachons une grande impportance à la qualité et la prise en charge du client. Contactez le +86 571 8905 8143 pour plus d'information.

Founded in 2015 with the pursuit for human and global health,Testsealabs Inc.creates innovative tech-nologies for the development of raw materials for diagnostic use.We offer diagnostic total solution such as rapid diaqnostic tests(RDTs),fluorescent immuno-diaqnostic tests, ELISA,molecular diagnostic tests(MDx)and clinical chemistry. We specialize in developing monoclonal antibodies and recombinant antigens in-house at our facility in China.We also have patented technoloqies includingfluorescentimmuno-diagnostics which will be one of the major IVD technologies of the future. Our facility is GMP,ISO9001and ISO13458 certified and we have CE FDA approval. Now we are looking forward to cooperating with more overseas companies for mutual development. Since its establishment,Testsealabs Inc has always insisted on R&D and innovation. At present, it has accumulated 1 software copyright and 50 authorized patents, including 4 invention patents, 46 new patents for use, and several special projects under application. Testsealabs Inc currently has more than 300 employees, an annual output of 300 million people, and a business area of 56,000 square meters. We pursuing the concept of "integrity, quality and responsibility", adhering to the tenet of quality first and serving the society, we constantly strive to develop new high-quality diagnostic raw materials, always adhere to the vision of serving the society and a healthy world, and are committed to promoting high-quality diagnostic products. Accurate diagnosis of all human diseases contributes to the cause of human health. Always find us here for solutions!

Shenzhen Huixin Biomedical Technology Co., Ltd. (hereinafter referred to as Huixin Bio) is a national high-tech enterprise co-founded by well-known scientists and industry experts in the field of exosomes. It is committed to promoting the research and application of exosomes in the field of early diagnosis and treatment of cancer, developing world-leading biomedical technologies, meeting urgent clinical needs, and continuously improving the automation and intelligence of products to overcome key bottleneck technologies in the field of exosome diagnosis and treatment. Huixin Bio was shortlisted for the national industry finals of the China Innovation and Entrepreneurship Competition in 2019, won the third prize of the "Startup Star Competition" in the biopharmaceutical industry, won the small and micro intellectual property advantage enterprise in Longhua District, Shenzhen in 2020, and passed the national high-tech enterprise certification in 2022.

Landwind Medical has been a professional medical equipment manufacturing company since 1994. With over 25 years of experience in the medical industry, today, Landwind has six R&D centers and four production lines around China, besides Shenzhen's headquarters. Also, Landwind has perceptive R&D teams of 300+ professionals with medical practice and product development backgrounds. Landwind Group has four subsidiaries manufacturing different categories of medical products: Landwind Bio: for in-vitro diagnostic equipment and reagent solutions; Joyheal: for hemodialysis solutions; Landsky: is a specialist in ventilator & anesthesia solutions; Landwind Health: for home care/medical solutions. Professionally, Landwind is accumulating, gaining many professional awards and certificates every year, among them the CE, ISO9001, and CMD certificates, besides hundreds of local awards, Medical Device Manufacturing certificates, and patents. Landwind's products and professional staff are always on the front line with medical companies in most medical exhalation and fairs early, aiming to expand its cooperation network and open new markets. Landwind Medical's distributing network exceeds 800 and has more than 120,000 active clients covering more than 150 countries.

Since 2003, Medicalsystem Biotechnology Co., Ltd. was first found in Ningbo, today we become one of the leading integrated systems and healthcare service providers of clinical diagnostics in China.Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit

Nantong Diagnos Biotechnology Co., Ltd. (Diagnos) is a professional POCT(point-of-care testing) manufacturer in China, found in 2006, specialized in researching, developing, manufacturing and distributing advanced medical instruments and in-vitro medical diagnostic products. Diagnos offers quality products in the following specialties: Fertility, Infectious Diseases, Tumor Markers, Cardiac Markers, Substance of Drug Abuse tests and etc.(2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)

Sansure Biotech Inc., now a listed company in China, established in 2008, is an integrated solutions manufacturer and provider with independent innovation of molecular diagnostics and gene technology, has over 10-year experience specialized in diagnostic reagents, nucleic acid diagnostic instruments, complete lab solutions and lab chain services. Sansure solutions for molecular diagnosis are compatible with majority of PCR detection instruments and lab environments based on unique technical platforms “global leading magnetic beads extraction system”, “one of the simplest and fastest one-step DNA/RNA lysis systems”, automated nucleic acid extraction system, POCT devices and real-time PCR instruments. Over 40% of its employees work for R&D and technical service departments, over one hundred of products with global registrations, including infectious diseases, cancer, maternal and child health, blood screening, emerging infectious diseases prevention and control, chronic disease management, etc. "Sansure solutions" have been widely used in nearly 160 countries worldwide, such as France, UK, Germany, Russia, the Philippines, Brazil etc., obtained certificates in over 65 countries, include NMPA China, US FDA EUA，ANVISA, TGA Australia, We are one of the companies with the largest number of overseas certificates. For more information, please contact us at info@sansure.com.cn

Established in 1981, Shanghai Kehua Bio-engineering Co., Ltd (KHB) is one of the largest developers, manufacturers and marketers of in vitro diagnostic products in China. In July 2004, we became the first listed company in Shen Zhen Stock Exchange focused on the IVD business. We offer a broad range of products covering three primary business segments: Diagnostic Reagents, Diagnostic Laboratory Instruments, and Evacuated Receptacles.

Shineco, Inc. Changzhou Biowin Pharmaceutical Co., Ltd., a subsidiary of Shineco, is mainly engaged in POCT testing business. According to the different types of diseases...

SmartNuclide Biopharma is a biopharmaceutical company that focuses on discovering and developing innovative biologics used in nuclear medicine, with a world-leading research and development technology platform for domain antibody-radiopharmaceuticals.

Snibe is a leading brand of Chemiluminescence immunoassay solution from Shenzhen, China. Also, Snibe is the first company who received FDA cleared on Chemiluminescence immunoassay product in China. With more than 2600 staffs, Snibe has been focusing on Chemiluminescence immunoassay solution for 29 years. At present, Snibe's products have been widely exported to more than 150 countries with 30000 installations globally. Best Quality, Best Service is our target. Snibe would like to be the pioneer in global diagnosis field.

VivaChek is a leading in-vitro diagnostics company dedicated to enhancing the quality of life by delivering precise and swift disease diagnoses. Our commitment lies in the advancement of healthcare through ongoing research and development in blood glucose monitoring systems, Hemoglobin & Lipid Testing System, FIA Testing System, lateral flow rapid test and Molecular Diagnostics. Our expertise encompasses the development, manufacturing, and distribution of top-tier biosensors and Point-of-Care Testing (POCT) products. Our biosensor offerings span a range of critical parameters, encompassing blood glucose monitoring systems, lactate analyzers, blood ketone meters, and uric acid analyzers. In addition to biosensors, our comprehensive POCT product portfolio includes state-of-the-art PCR, immunoassay, and biochemistry solutions. With a focus on precision, efficiency, and accuracy, our POCT products cater to diverse medical needs, contributing to the rapid and reliable diagnosis of various health conditions.

The company was founded in December 2005, built a variety of plant and GMP workshop, office space, auxiliary housing, with various types of imports and domestic advanced equipment. The company is a professional R&D, production, sales of rapid in vitro diagnostic reagents of the national high-tech enterprises, Zhejiang Province post-doctoral research station and Huzhou City academician expert workstation set up units. At present, the company's products are widely used in Infectious Disease Rapid Test, Drugs of Abuse Test, Pregnancy & Fertility Tumor Marker Cardiac Marker and other fields, with repeatability and specificity, high sensitivity, easy to operate and other technical characteristics. During the outbreak, the company's new coronavirus testing reagents are widely sold to all corners of the globe. It has made outstanding contributions to the fight against the new coronavirus for all mankind. Since its inception, the company to scientific and technological innovation as the driving force for development, committed to the cause of human health, in order to promote high-tech diagnosis and treatment technology, improve the level and quality of human medical services and efforts. At present, the majority of the company's products have been CE certificated. The company now hopes to expand into the European market. Find local partners in Europe. Better service to the European market.

Zhuhai Livzon DiagnosticsInc. (hereinafter referred to as “Livzon Diagnostics”) was established in 1989. It is the first high-tech subsidiary of thelisted company, Livzon Pharmaceutical Group (A-shareand H-share listed company),whospecializing in in-vitro diagnosticsin research, developing, manufacturingand marketing of diagnosis productsand automation equipment.Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)

More than a decade ago, with the goal of Setting New Standards in Price and Performance, SonoScape specialized itself in ultrasound diagnostic systems and transducers. In 2004 SonoScape released the world's first 15 inch LCD portable color Doppler Ultrasound System. Shortly afterwards SonoScape's product received FDA approval and CE certification and started to be serviced all over the world. Motivated by our goal, we have established a global R&D team with research centers in China and abroad to make the innovative medical technologies accessible and affordable. To reach this goal, SonoScape has continuously introduced new medical products and technologies into the market every year. Consequently SonoScape has expanded into the fields of Endoscopy and Minimally Invasive Surgery to continue providing better healthcare solutions to the world for the purpose of meeting the diagnostic needs of our worldwide customer base. With the Value Proposition of "Unlocking Life's Potential",​ SonoScape has developed and manufactured high quality medical equipment which has benefited millions of people. SonoScape products have become indispensable tools for doctors and clinicians world wide when making critical decisions and reducing their workload. Inspired by the medical needs of the world, we shall continue to dedicate ourselves to delivering meaningful and accessible medical solutions to change lives for the better.