ACCURDX Quietly Rises with China's First Fully Automated Flexible Coagulation Testing Line and Proprietary Reagent Raw Materials

Can Product Distributors Transition into R&D and Manufacturing? ACCURDX Answers with China’s First Fully Automated, Flexible Coagulation Testing Assembly Line Independently Developed: Yes.

In 2002, Wang Xing established Jinan Kangli Trading Company, becoming the distributor for Sysmex Corporation in Shandong Province. Over the next decade, Kangli achieved robust growth, with annual sales reaching RMB 300 million by 2015. Among its product portfolio, coagulation products accounted for the largest share and demonstrated the fastest growth.

Pressing forward, in 2014 he began experimenting with the R&D of antibody raw materials. “When the test results from reagents produced using our self-developed antibody raw materials showed good concordance with those from original imported reagents, the path toward transforming into coagulation product R&D and manufacturing became increasingly clear.” In 2017, Shandong Aikeda Biotechnology Co., Ltd. (ACCURDX, hereinafter referred to as “Aikeda”) was established in Jinan. The company integrates the R&D, production, sales, and technical services of antibody raw materials, diagnostic reagents, diagnostic instruments, and fully automated coagulation assembly lines.

Over the past six years, ACCURDX has obtained 45 manufacturing licenses, registration certificates for 11 fully automated analyzers, and registration certificates for 35 reagent kits, along with 83 patents including invention patents. Its portfolio covers coagulation testing systems, immunoassay systems, specific protein testing systems, and reproductive health testing systems. Notably, it has developed China’s first fully automated flexible coagulation testing assembly line, the ADX-X1.

From importing products as an agent to independently developing and manufacturing them, ACCURDX has embarked not only on a path of corporate transformation but also on a breakthrough journey of independent innovation, shattering the monopoly of imported products in the high-end medical market.

As the healthcare market and international landscape evolve, the import product distribution industry has entered a critical phase, with significantly increased uncertainties and risks. How to transform has become an urgent issue for many distributors in the sector. “During our more than ten years of distributing and selling imported coagulation products, we have identified numerous issues where imported products are ill-suited for development in the Chinese market. These challenges can only be addressed by domestic coagulation manufacturers and products. However, the path to localization is ‘arduous and long.’ Antibody raw materials, situated at the very top of the entire industrial chain, present the greatest difficulty in achieving domestic production,” said Ma Wenxin, General Manager of Marketing at ACCURDX.

IVD raw materials are located at the upstream end of the entire industry chain. Their quality determines the quality of in vitro diagnostic (IVD) reagents and the accuracy of final diagnostic results, making them one of the core segments of the IVD industry chain. However, domestically produced antibody raw materials lag significantly behind imported products in performance indicators such as quality control, manufacturing processes, and purity. This has led to a long-term reliance on imports for key raw materials by downstream diagnostic reagent manufacturers, with the antibody raw material market being nearly monopolized by foreign companies. On the other hand, due to potential instability in the quality and batch consistency of domestically produced antibody raw materials, along with the need for re-registration, it is difficult for domestic antibodies to break through and gain market traction.

During the process of acting as a product distributor, the “chokehold” issue concerning IVD raw materials became increasingly prominent. In 2014, Wang Xing established a Raw Material R&D Center to develop biological raw materials such as antibodies and antigens. One year later, his team successfully developed in-house FDP/DD/ATⅢ antibody raw materials, which demonstrated favorable performance in kit assays and could provideD-Dimer and FDP Assay Reagents with Wide Dynamic Range, High Sensitivity, Good Specificity, and a Complete Traceability System. With such favorable outcomes, the Jinan Reagent R&D Center and the Jinan Instrument R&D Center were subsequently established, and ACCURDX Biotechnology, aiming for “precision diagnosis,” was founded in Jinan.

Starting from antibody raw materials, the ACCURDX team has gradually expanded its product development scope to cover a full range of offerings, including reagents, instruments, fully automated assembly lines, and software. The projects encompass coagulation testing systems, immunoassay systems, specific protein testing systems, and reproductive health testing systems.

Starting from Jinan, ACCURDX has gradually expanded its R&D centers across China, with the establishment of the Instrument R&D Center in Shanghai, the Automation Equipment R&D Center in Suzhou, the Instrument R&D Center in Changchun, the Reagent R&D Center in Suzhou, and the Global Marketing and Academic Center in Beijing. “We aim to build ACCURDX into a platform characterized by multiculturalism, inclusiveness, and innovation, attracting diverse talents and accelerating the process of import substitution,” said Ma Wenxin.

Currently, ACCURDX is the domestic manufacturer with the largest number of registered coagulation reagent items. It not only provides all seven routine coagulation reagents but also offers special coagulation tests such as anti-Xa and lupus anticoagulant, achieving a correlation of over 95% with comparable international products. Furthermore, numerous other coagulation test items are under development, including activated Factor II inhibitors, direct oral anticoagulant (DOAC) drug concentrations, Protein C/Protein S, von Willebrand factor, thrombin-antithrombin complexes, plasmin-α2-antiplasmin complexes, thrombomodulin, tissue-type plasminogen activator-inhibitor complexes, anticardiolipin antibodies, and anti-β2 glycoprotein I antibodies. These are expected to be registered and launched on the market within two years.

A Look at ACCURDX: In just six years since its establishment, it has emerged as a dark horse in the IVD coagulation sector with unstoppable momentum. This success is attributed to the “hardcore” team behind ACCURDX, which possesses capabilities akin to a “dimensional strike.”

ACCURDX’s core team comprises multidisciplinary professionals with extensive R&D and management experience in multinational corporations or leading IVD companies. This includes founder Wang Xing, who has over 30 years of experience in the IVD industry and has long been at the forefront of the IVD market, as well as Marketing General Manager Ma Wenxin, who brings 30 years of experience spanning prestigious institutions and companies such as Peking Union Medical College Hospital, Sysmex, bioMérieux (France), Thermo Fisher Scientific, and Werfen.“We can proudly state that our R&D team is fully capable of developing the best coagulation products for both the domestic and global markets. Our leaders and their teams come from more advanced research fields, so their entry into the coagulation sector represents a ‘higher-dimensional strike.’ ACCURDX’s coagulation reagents aim not only to achieve domestic substitution for routine tests but also to develop assays that even foreign manufacturers cannot provide. Furthermore, our instruments are designed to meet the future needs of coagulation laboratories, with products developed based on fully automated coagulation testing lines,” said Ma Wenxin.

Ma Wenxin, with 30 years of experience in the clinical laboratory industry, has witnessed nearly the entire history of the development of coagulation testing in China.

In 1995, Peking Union Medical College Hospital introduced the ACL-3000 Plus fully automated coagulation analyzer, marking the entry of domestic coagulation testing into the era of full automation. In 2000, the Ministry of Health issued Notice No. 412 (2000) on the “Standard Operating Procedures for Bleeding and Clotting Time Tests,” which phased out and standardized manual methods for bleeding and clotting-related test items, thereby triggering explosive growth in coagulation analyzers and reagents. In 2015, with the widespread adoption of the concept of precision medicine, higher demands were placed on the clinical diagnostic role of laboratory testing, leading to a continuous rise in clinical emphasis on coagulation testing and ushering in a second surge of growth in the coagulation sector.

Coagulation testing effectively assists clinicians in analyzing the causes of thrombosis and hemorrhage, facilitating the accurate diagnosis, screening, treatment, and prevention of thrombotic disorders—including cerebrovascular and cardiovascular diseases—as well as bleeding disorders. It is also used for preoperative coagulation screening to identify the underlying causes of bleeding in patients for targeted therapy, particularly enabling coagulation monitoring in critically ill patients.

With the rapid development of China's economy, public awareness of health and healthcare has been continuously increasing. The number of patient visits and diagnostic tests at hospitals of all levels has surged dramatically. This growth has doubled the workload in clinical laboratories, creating an urgent need to improve testing efficiency. On the other hand, constrained by complex laboratory workflows and insufficient staffing, users are turning their attention to more automated equipment. Fully automated assembly lines of various types have become the ultimate solution to address these challenges.

Since 2009, fully automated laboratory automation lines have begun to enter the clinical laboratories of large hospitals in China, with imported brands dominating the market and domestic products holding a negligible share. From the perspectives of product demand, technical specifications, and system stability, domestic startups are unable to undertake such large-scale projects, resulting in only a handful of Chinese enterprises possessing both the determination and capability to develop fully automated laboratory automation systems.

In 2016, Werfen launched its fully automated coagulation testing assembly line, sparking a surge in the adoption of integrated coagulation workflows across the market. This prompted the ACCURDX team to recognize that for domestic coagulation analyzers to break through the dominance of overseas giants, their independent R&D efforts must focus on high-end products, as “future competition in the premium coagulation market will inevitably center on coagulation assembly lines.” To this end, ACCURDX developed two fully automated coagulation assembly lines, ADX-E1 and ADX-X1, based on distinct technological pathways. These solutions were custom-designed to meet the needs of high-end clients, taking into account multiple factors such as processing speed and footprint.

The ADX-E1 Fully Automated Cascading Coagulation Assembly Line is a workflow system designed based on the GW3000 Fully Automated Coagulation Analyzer., consisting of an input/output sample buffering module, a centrifugation module, a track-switching module, a measurement module, a bridge module, a retest buffering module, a control module, and accessories; it enables high-speed testing, intelligent sample allocation, and sealed puncture sampling.

  Fully Automated Cascade Coagulation Assembly Line ADX-E1

The GW-3000 detection module used in the ADX-E1 is a fully automated coagulation analyzer independently developed by ACCURDX. It employs clotting, chromogenic substrate, and immunoturbidimetric methods to monitor coagulation, anticoagulation, fibrinolysis, and antifibrinolysis functions. With its compact size and high speed, it achieves a D-Dimer testing throughput of up to 150 tests per hour. Its modular design allows for easy upgrade to a fully automated coagulation testing line by adding multiple detection modules as needed.

With the same sample testing capacity, the ADX-E1 has the smallest footprint. Taking the ADX-E1/3 as an example, configured with one sample loading/unloading unit, three GW-3000 detection modules, and one retest buffer module, the ADX-E1 occupies only 4 square meters, making it the most space-saving fully automated coagulation testing laboratory automation line currently available on the market.

 China's First Fully Automated Flexible Coagulation Testing Assembly Line ADX-X1

ADX-X1 is the first flexible automation line in China specifically designed for high-volume coagulation testing for super users.“Flexibility” means that modules can be added or removed from the assembly line according to laboratory sample volume and turnaround time requirements. Samples are transported between modules via a track system. Each testing unit is capable not only of online integrated operation but also of offline independent operation during periods of low sample volume or for nighttime emergency tests. Furthermore, “flexibility” signifies that the ADX-X1 can connect not only with ACCURDX coagulation instruments but also, based on user requirements, be customized to interface with third-party coagulation analyzers, biochemistry analyzers, or chemiluminescence immunoassay analyzers, making it a compatible, open, and highly efficient fully automated coagulation testing assembly line.

In the face of a future competitive landscape characterized by intense rivalry, ACCURDX has focused its sights on the research, development, and manufacturing of specialized coagulation products, proposing a “1+2+N” strategy, namely “One Core, Two Wings, and Multiple Items.” The “One Core” refers to establishing coagulation testing as the core business, positioning ACCURDX as a specialized manufacturer of coagulation products. The “Two Wings” entail building two technological platforms—chemiluminescence and immunoturbidimetry—to develop a wider range of clinically required test items (the “N” items).

Centered on the “One Body, Two Wings, Multiple Items” product strategy, ACCURDX has successfully launched the AC-1000 fully automated chemiluminescence immunoassay analyzer using acridinium ester labeling. Based on this platform, the company has developed cardiovascular and cerebrovascular disease solutions focused on myocardial infarction and heart failure, including the clinically promoted “Three-Marker Chest Pain Panel” and “Four-Marker Chest Pain Panel.” These panels detect cardiac injury markers troponin I (TnI) and troponin T (TnT), the inflammatory marker procalcitonin (PCT), the pulmonary embolism exclusion marker D-dimer, and heart failure markers B-type natriuretic peptide (BNP/N) and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Furthermore, as more novel thrombosis and hemostasis indicators will be tested on the chemiluminescence platform in the future, ACCURDX is currently developing assays for thrombin–antithrombin complex (TAT), plasmin–α2-antiplasmin complex (PIC), thrombomodulin (TM), tissue-type plasminogen activator–inhibitor complex (t-PAIC), anticardiolipin antibodies (aCL), and anti-β2 glycoprotein I antibodies (anti-β2 GP1) on the AC-1000 chemiluminescence platform.

Immunoturbidimetry is one of the most important methodologies in coagulation testing. ACCURDX has not only adopted immunoturbidimetric technology in its fully automated coagulation analyzers but has also developed the CR-2000, a more powerful fully automated specific protein analyzer. This instrument integrates two immunoturbidimetric analysis techniques—nephelometry and turbidimetry—allowing for flexible selection based on the concentration of different analytes, making it highly suitable for the development of new test items. Currently, ACCURDX is developing colorectal cancer screening protocols and urine protein analysis projects based on immunoturbidimetry.

“The integration of fully automated coagulation analyzers, fully automated chemiluminescence detection technology, dual-method immunoturbidimetric assay technology, fully automated laboratory assembly lines, and a comprehensive portfolio of clinical testing items not only foreshadows the future technological trajectory of coagulation testing but also embodies ACCURDX’s core philosophy of prioritizing R&D and technological innovation,” stated Ma Wenxin.

Challenging internationally renowned brands, achieving domestic substitution in the high-end coagulation market, and showcasing the quality of Chinese intelligent manufacturing in the global IVD market—this is ACCURDX’s “dream.” “Although we have only just begun, we have always maintained a long-term vision. Our aspirations are boundless; we aim not only to become a domestic leader but also to expand overseas and enter the international market,” said Ma Wenxin.

This July, ACCURDX will make its debut at the 75th AACC Annual Scientific Meeting & Clinical Lab Expo in California, USA, marking the beginning of its international journey. Let’s stay tuned!