Company Profile

Lumigenex (Suzhou) Co., Ltd. established in 2010, is a national high-tech enterprise which integrates the research and development, manufacturing, and sales of in vitro diagnostic (IVD) products based on functionalized nanomaterials. The company has consistently focused on the development, production, sales, and service of quantitative point-of-care testing (POCT) products, providing customers with professional rapid diagnostic solutions and comprehensive intelligent solutions for chronic disease management.

The company operates a 70,000 Sq ft GMP facility with an annual production capacity of 300 million tests, has passed ISO 13485 quality management system certification, and holds manufacturing licenses for Class II medical devices and Class II and III diagnostic reagents. It has obtained 31 domestic medical device product registration certificates, 57 overseas CE certifications, 42 patents, and 3 software copyrights. The company has been recognized with numerous honors, including “National High-Tech Enterprise,” “Jiangsu Provincial POCT Engineering and Technology Center ,” “Jiangsu Province Innovative SME,” “Jiangsu Province Quality Credit Grade A Enterprise,” “Jiangsu Province Science and Technology-Based SME,” “Suzhou Technologically Advanced Service Enterprise,” “Suzhou Gazelle Program Enterprise,” and “Industrial Park Pre-IPO Incubation Enterprise.”

As the Principal organization for a sub-project under the National Health Commission’s “13th Five-Year Plan” Major Infectious Disease Program, the company has established strong cooperative relationships with many renowned domestic and international research institutes, universities, and multinational corporations. It has also undertaken major national projects such as the Ministry of Science and Technology’s Major New Drug Innovation Program, key provincial achievement transformation projects, and international cooperation projects.

The company has an R&D team led by “National Leading Talent” experts and has achieved breakthrough progress in the field of portable quantitative POCT systems. Its Time-Resolved Fluorescence Immunoassay Analyzer (LTRIC-600) was selected as one of 26 innovative medical products from a total of 30,000 products by the Ministry of Science and Technology in 2018. With high sensitivity and accuracy, the product can be used for rapid screening of cardiovascular diseases, women’s health conditions, infection control, oncology, and more.

The Urinary Microalbumin/Creatinine Ratio (ACR) combined test kit adopts nano-enhanced time-resolved fluorescence immunoassay technology, enabling fully quantitative testing of random urine samples with accurate results and convenient operation. This indicator has been listed as a priority standard for early kidney disease screening as well as for the diagnosis and staging of chronic kidney disease. Both ACR and the Gout flaring indicator cancer antigen CA72-4 have been included in the Suzhou Biopharmaceutical and Health Industry Innovative and Premium Product Promotion and Application Catalog.

The company’s independently developed dry chemistry analyzers and supporting POCT reagents can store data and support USB/Bluetooth output, offering easy operation, accurate results, strong scalability, personalized interference capability, and excellent stability. These products can be used for testing lipid panels, creatinine, uric acid, urea, ketone bodies, homocysteine, and more, facilitating timely intervention and management for patients with hyperlipidemia, diabetes, renal impairment and chronic kidney disease, H-type hypertension, stroke, and other high-risk cardiovascular and cerebrovascular diseases.

As a cooperative member enterprise of China Chest Pain Centers, several of the company’s acute myocardial infarction and heart failure instruments and reagent kits for chest pain centers and emergency departments have contributed to the nationwide construction of chest pain centers. As a strategic partner of the Asia-Pacific Hyperuricemia and Gout Alliance, the company’s CA72-4, ACR, and dry chemistry analyzers and reagent kits have supported the standardized development of HGMC sub-centers nationwide.

In line with the development trends of tiered diagnosis and treatment at the primary care level and at-home care, the company actively responds to China’s “Healthy China 2030” national strategy. Focusing on the “four highs and one chronic condition,” it is building an ecosystem for chronic disease monitoring, AI-assisted consultation, and intelligent management, providing products for early screening, early intervention, and subsequent home-based self-monitoring for chronic diseases. These efforts aim to benefit hundreds of millions of patients with chronic diseases and to advance chronic disease management into a new era of integrated digital and intelligent monitoring both inside and outside hospitals.

Mission

To provide total diagnostic solutions for acute or chronic diseases across the lifespan of human beings anywhere anytime.

Vision

To become and be recognized as an indispensable partner in the advancement of human well-being, hygiene and health.