Zhejiang University to Transfer Two IVD Patents for RMB 300,000: Enabling Rapid Immunoassay and Closed-System Nucleic Acid Analysis

How can immune diagnostics be made faster and more convenient? How can nucleic acid analysis be made faster, more accurate, and free from the risk of cross-infection? Two patents recently proposed for transfer by Zhejiang University provide the answers.

On September 10, Zhejiang University issued a public notice announcing the transfer of two technologies: “An Automated Device for Heterogeneous Immunoassay-Based Rapid Analysis and Its Method of Use” and “A Kit, Device, and Analytical Method for Nucleic Acid Analysis Under Fully Closed Conditions,” at a transfer price of RMB 300,000.

Both proposed patents for transfer were developed under the leadership of Professor Fang Qun and Professor Pan Jianzhang. The two professors have made significant contributions to the fields of immunodiagnostics and nucleic acid analysis. Professor Fang Qun is a recipient of the National Science Fund for Distinguished Young Scholars and serves as the Director of the Institute of Microanalytical Systems in the Department of Chemistry at Zhejiang University. He has been engaged in research on microfluidic chip analysis since 1998, holding 29 granted patents and publishing more than 130 academic papers in the field of microfluidic analysis.

Professor Pan Jianzhang is an Associate Researcher in the Department of Chemistry at Zhejiang University and Deputy Director of the Institute of Molecular Intelligent Manufacturing. He has long been dedicated to the miniaturization, automation, and intelligent development of microfluidic analytical instruments. He holds nine authorized national invention patents and has customized various microfluidic instruments for numerous research institutions, including Tsinghua University, Beijing Institute of Technology, and the Institute of Microbiology of the Chinese Academy of Sciences.

The two patent achievements that Zhejiang University proposes to transfer focus on the IVD sector’s largest market segment and its highest-growth-potential segment, namely immunoassay diagnostics and molecular diagnostics.

Among these, “An Automated Device for Heterogeneous Immunoassay-Based Rapid Analysis and Its Method of Use” aims to address the challenges of rapid detection in sudden-onset diseases and acute infectious diseases, with the goal of establishing a simple, rapid, and accurately quantifiable portable immunoassay system and method to enable on-site, rapid, and accurate quantitative immunoanalysis.

Immunodiagnostics is currently the largest sub-segment within the in vitro diagnostics (IVD) field. According to iResearch, the global IVD market size had reached $97 billion by the report’s publication date. Despite a certain degree of contraction in the IVD market in 2023 due to special circumstances, it is still expected to surpass the $100 billion mark by 2025.

Among these, immunodiagnostics—applicable to infectious diseases, endocrinology, and tumor detection—currently holds the largest share of the IVD market at 45.5%. Furthermore, POCT has demonstrated relatively rapid growth, reaching a market size of nearly USD 1 million in 2022, with its market share increasing from 29% in 2017 to 37.8%.

Zhejiang University’s patent, “An Automated Device for Heterogeneous Immune Rapid Analysis and Its Method of Use,” is a patented achievement applied to the POCT sector of immunodiagnostics.

Specifically, according to the patent specification, in the immune diagnostic POCT market, although heterogeneous immunoassay techniques such as enzyme-linked immunosorbent assay (ELISA) and fluorescence immunoassay have become the primary technologies for quantitative immune analysis in clinical and laboratory medicine due to significant improvements in specificity and sensitivity, they still face challenges such as long turnaround times and cumbersome procedures. Consequently, they are unable to meet the testing demands for many sudden-onset diseases, such as acute myocardial infarction, and acute infectious diseases.

Immunochromatographic strips are limited in applications requiring precise quantification because they can only provide qualitative or semi-quantitative results. As for microfluidic technology, although it has achieved automation of the entire heterogeneous immunoassay process and effectively addressed the issue of prolonged incubation times, significant challenges remain in chip fabrication, process control, and on-site sample introduction. Therefore, the instruction manual explicitly states that “it is still far from practical application.”

In this context, the invention employs a capillary system and programmable liquid driving technology to provide a rapid automated device for heterogeneous immunoassays. The device consists of a capillary tube, a reagent tube, and a programmable micropump, which are connected in sequence to form a fluidic channel.

Among these, the capillaries are made of transparent materials such as quartz, glass, or polystyrene to facilitate direct in situ optical detection after the reaction is complete. Furthermore, the capillaries have a small inner diameter, ranging from only 10 to 5,000 micrometers, which increases the specific surface area of the channels, thereby enhancing reaction efficiency and shortening the incubation time for immune reactions.

Furthermore, the operation of this device is divided into two phases: preparation and analysis implementation. The complex multi-reagent wash solution dispensing steps from the original analytical process are advanced to the preparation phase and stored in reagent tubes using pre-encapsulated liquid segment technology. This significantly simplifies operations during the analysis implementation phase and reduces on-site analysis time.

Moreover, this patent achieves full automation of liquid handling throughout the multi-step heterogeneous immunoassay process. Compared with conventional heterogeneous immunoassays, it offers significant improvements in both turnaround time and operational convenience.

Another patent outcome that Zhejiang University intends to transfer this time targets the efficiency and cost issues in the molecular diagnostics sector.

Molecular diagnostics is one of the most promising segments within the in vitro diagnostics (IVD) market. According to iResearch, the global molecular diagnostics market size has grown from USD 10.2 billion in 2018 to USD 18.4 billion in 2022. With the increasing adoption of molecular diagnostic technologies in areas such as infectious diseases, cancer, and genetic disorders, along with the development of third-generation digital PCR, the market is expected to maintain a high growth rate, reaching USD 37.5 billion by 2026.

However, alongside the market’s rapid growth, challenges such as prolonged turnaround times, high costs, heavy workloads, and false positives caused by cross-contamination in open environments of conventional laboratories have also emerged. Microfluidics is an effective technological approach for achieving full automation of complex nucleic acid analysis workflows and integrating the required components, and companies have already begun to deploy related products.

However, even so, these products still suffer from issues such as complex disposable kit structures, stringent manufacturing requirements, and high costs, making it difficult to promote their widespread adoption in small- and medium-sized medical institutions and primary care facilities.

Zhejiang University’s “Kit, Device, and Analytical Method for Nucleic Acid Analysis Under Fully Closed Conditions” employs flexible material chamber walls to seal nucleic acid extraction probes, reagents, and other components within an independent sealed chamber for nucleic acid amplification analysis. This approach achieves automation of nucleic acid analysis while completely eliminating cross-contamination risks during sample pre-treatment, transfer, and amplification reactions.

Furthermore, the invention pre-measures and loads all reagents required for nucleic acid detection into the respective containers of the kit during the manufacturing stage, sealing them with a film. This significantly simplifies the handling of complex reagents during nucleic acid analysis and reduces the requirements for associated analytical instruments.

Furthermore, the probe of this invention integrates key functional components such as a reagent seal-piercing mechanism and a nucleic acid binding region. Through the coordinated movement of a single probe, it achieves full automation spanning sample-reagent mixing, nucleic acid extraction, purification and washing, to elution and amplification. Consequently, the patented invention features ease of automation and strong versatility.

Moreover, in addition to being amenable to automated design, the device adopts a simplified structural design to reduce production costs, thereby laying a solid foundation for large-scale adoption and widespread application.

When discussing the IVD industry, in addition to its substantial market size and encouraging growth rate, there is one term that cannot be overlooked: domestic substitution.

Amid the ongoing wave of domestic substitution across various specialized sectors in recent years, a number of Chinese companies have delivered particularly standout performances in the IVD market.

Taking biochemical diagnostics as an example, according to the China Business Industry Research Institute, although foreign manufacturers such as Danaher, Roche, and Johnson & Johnson still held approximately 35% of China’s biochemical diagnostics market share in 2019, larger domestic companies like Mindray Medical and Meikang Biochemical also accounted for about one-third of the market. Furthermore, at present, domestic manufacturers hold 70% of the market share for biochemical reagents in China.

Coincidentally, in the sector of large-scale chemiluminescence immunoassay (CLIA) analyzers, domestic manufacturers are also actively promoting equipment installation in hospitals to capture market share. For instance, in 2022, four leading Chinese CLIA companies—Snibe, Autobio, Maccura, and YHLO—each surpassed 1,000 newly installed units. Among them, by the end of 2022, Snibe had become the domestic manufacturer with the highest cumulative number of installed units in China, with the proportion of its high-throughput X8 analyzer rapidly increasing from 30.3% in 2020 to 50.4% in 2022, achieving continuous breakthroughs in installation volume.

Recently, the IVD industry has seen another piece of good news—Mindray Medical achieved RMB 7.66 billion in revenue in the IVD sector in the first half of 2024, representing a year-on-year increase of 28.16%. Among these, chemiluminescence business grew by over 30%, and consumables such as reagents also experienced rapid growth. Some media outlets even stated outright: "If Mindray Medical and Roche Diagnostics maintain their current growth rates, Mindray will surpass Roche Diagnostics in the IVD field by 2028."

From the reasons behind Mindray Medical’s IVD business maintaining rapid growth, we can extract two key terms—volume-based procurement and intelligent automation lines.

This year is a pivotal one for enhancing the quality and expanding the scope of centralized procurement for in vitro diagnostics (IVD). With the support of centralized procurement, high-quality domestic products are seizing market share, thereby accelerating the pace of import substitution. Meanwhile, as profit margins shrink, centralized procurement is also driving domestic enterprises to explore new avenues for profit growth and launch offensive strategies focused on innovative products.

Furthermore, under the influence of centralized procurement, intelligent automation lines have become a critical competitive battleground for in vitro diagnostics (IVD) companies and an essential pathway for the growth of domestic enterprises. This is because it will become increasingly difficult to expand market share by relying solely on standalone instrument installations, while the trend toward hospital laboratory automation lines will become more pronounced. Consequently, a consensus has emerged within the IVD industry: stabilizing market position requires driving reagent sales by increasing the installed base of instruments.

In response, numerous domestic companies have chosen to deploy intelligent automated laboratory assembly lines, gradually diverging into two strategic approaches: in-house development and original equipment manufacturing (OEM). A select few enterprises, including Mindray Medical, Autobio Diagnostics, Maccura Biotechnology, and Fosun Diagnostics, have adopted the in-house development strategy, while the majority of domestic companies have opted for the OEM model to acquire such assembly lines.

Nevertheless, it is worth noting that, based on the current competitive landscape, the domestic laboratory automation line market remains dominated by Roche, Abbott, Beckman Coulter, and Siemens. Although Chinese brands have launched initiatives in intelligent automation lines, exerting a certain impact on the performance of these foreign enterprises, there is still a long way to go before their dominant position can be shaken. This situation applies not only to the automation line market but also to many niche segments within the IVD industry.