Can POCT Be Faster? This Company Aims to Bring Breakthrough Technology to the IVD Industry

In the field of in vitro diagnostics, most clinically used detection methods, such as enzyme-linked immunosorbent assay (ELISA), chemiluminescence, and electrochemiluminescence, have been in existence for decades. In China, overseas giants still dominate the majority of the market share. Domestic manufacturers exhibit a fragmented competitive landscape characterized by small-scale operations, serious product homogenization, and a scarcity of enterprises capable of producing both instruments and reagents. Furthermore, no highly competitive domestic industry leader has yet emerged.

Over the past two years, COVID-19 testing has opened a pathway for IVD companies to make quick profits, significantly boosting market attention. However, the surge in performance driven by COVID-19 testing was not the result of technological innovation. Currently, in terms of throughput, chemiluminescence immunoassay (CLIA) technology dominates the in vitro diagnostics sector, while miniaturization is being advanced by various microfluidic technologies. Chemiluminescence and electrochemiluminescence, which are strongly monopolized by foreign giants, represent the current pinnacle of immunoassay technology. Nevertheless, innovative companies are striving to achieve breakthroughs with next-generation technologies to overcome these barriers and bring new perspectives to the IVD industry.

Recently, VCBeat interviewed the IVD company Weiao Cloud, which is dedicated to the research, development, manufacturing, and sales of biosensors, biochips, and testing instruments centered on its Molecules Movement Control (MMC) particle manipulation technology.Project founder and CTO Liu Xiaozhu shared with us his insights into the in vitro diagnostics sector, as well as the new generation of rapid particle manipulation testing technology invented by him and his team.

COVID-19 was not the first pandemic, nor will it be the last. During this pandemic, people became accustomed to point-of-care testing or on-site sampling. In response to surging demand, many in vitro diagnostics (IVD) companies rapidly integrated resources to establish COVID-19 testing pipelines. However, with continuous price reductions under medical insurance reimbursement and centralized procurement by the National Medical Products Administration driving COVID-19 testing prices to their lower limit, revenue from labor-intensive and policy-driven markets can no longer sustain the growth of many IVD and related enterprises.

Without breakthrough technologies, enterprises will ultimately be confined to seeking survival in the fiercely competitive "red ocean" markets.

In vitro diagnostics is inherently an industry characterized by relatively slow technological advancement. In 1959, Rosalyn Yalow invented radioimmunoassay (RIA). Over the subsequent half-century of continuous development in radioimmunoanalysis, nearly 1,000 RIA test variants were developed, covering a wide range of fields. In China, more than 3,000 medical institutions have employed RIA testing technology; as recently as last year, institutions in Shenzhen were still procuring radioimmunoassay equipment.

In the 1970s, second-generation testing technologies represented by enzyme-linked immunosorbent assay (ELISA) emerged, providing rapid, cost-effective, convenient, and non-radioactive analytical measurements. Although less sensitive than radioimmunoassay (RIA), these methods were rapidly adopted for the clinical detection of various bioactive substances and biomarkers, gradually replacing radioimmunoassay techniques in clinical practice.

In the 1990s, electrochemiluminescence immunoassay (ECLIA) technology emerged with higher technical barriers. The instruments involve technologies such as micro-volume pipetting, non-destructive separation, chemiluminescence, and optical signal detection. To this day, the market remains monopolized by industry giants including Roche, Abbott, Siemens, and Danaher.

Although domestic IVD companies have grown rapidly over the past decade, with certain technologies catching up—particularly in clinical chemistry and enzyme-linked immunosorbent assay (ELISA)—the localization rate for chemiluminescence remains at only 20%. The instruments are predominantly based on closed-system designs, requiring downstream customers to continuously purchase high-cost reagents.

Overall, the Chinese in vitro diagnostics (IVD) sector is characterized by low market concentration. Overseas giants hold a 50% market share, while domestic manufacturers exhibit a fragmented and small-scale competitive landscape with serious product homogenization. Meanwhile, Chinese enterprises capable of producing both instruments and reagents are exceedingly rare.

It was in response to this market landscape that Liu Xiaozhu, founder of Weiao Cloud, decided to return to China to launch her entrepreneurial venture. In 2011, while at the University of Tennessee, she collaborated with Professor Jayne Wu’s team—experts in microfluidics and micro-electromechanical systems (MEMS)—to pioneer the application of particle manipulation technology in infectious disease testing.

According to Liu Xiaozhu, microparticle manipulation, as a novel testing technology platform, can accelerate affinity reactions and, by leveraging direct electrical detection results, is capable of detecting 80% of liquid-phase-based assays currently available on the market.

In 2016, Dr. Liu Xiaozhu returned to China to advance the MicroAoyun project, aiming to commercialize microparticle manipulation technology and contribute to China’s in vitro diagnostics industry. Currently, MicroAoyun is dedicated to the research, development, and manufacturing of biosensors, biochips, and diagnostic instruments centered on microparticle manipulation technology.

Principle of Microparticle Manipulation Technology: By leveraging specific electrode arrangements on biochips to generate microelectrophoresis-like effects, this technology actively controls and accelerates the binding between target analytes and bioprobes, while detecting binding changes through electrical signals.

The General Manager of Meridian, a publicly listed U.S. in vitro diagnostics company, has publicly stated that particle manipulation technology will serve as the cornerstone for a series of user-friendly and rapid diagnostic solutions in the future.

“As the name suggests, microparticle manipulation technology controls fine particles within microphysiological systems, such as antigens, antibodies, nucleic acids, bacteria, and even small molecules. While conventional techniques typically rely on thermal diffusion and Brownian motion for reaction processes, microparticle manipulation enables active control over the orientation of particles in solution, thereby significantly enhancing reaction efficiency.”

According to MicroAurora Cloud, this technology enhances the efficiency of immune responses, reducing the total reaction time to 5–60 seconds and lowering the detection limit for antibodies to 10–15 g/mL, while being scalable to thousands of immunoassay items.

Microparticle manipulation technology is closely related to biochips. To generate the pulling force required for controlling microparticles, extremely high electric field strengths are needed, which can be achieved by increasing the voltage or reducing the distance. Only on biochips can electrodes be fabricated at the micron or even sub-micron scale.

“Micro- and nanofabrication technologies in biochips constitute a foundational basis for microparticle manipulation techniques,” said Liu Xiaozhu.

Micro- and nanofabrication technology refers to manufacturing techniques for producing components, assemblies, or systems with feature sizes at the micrometer and nanometer scales. The primary steps include thin-film deposition, mask fabrication, and pattern formation and transfer.

Subsequently, sensing is required to convert physical or chemical information from physiological activities into optical, electrical, or mechanical signals. For instance, to convert into optical signals, methods such as fluorescent labeling and chemiluminescence or electrochemiluminescence can be employed; to convert into electrical signals, techniques like nanopore sequencing can be utilized; and to convert into mechanical signals, changes in microbeam deformation or vibration signals induced by adsorption can be leveraged.

Since Affymetrix produced the world’s first commercialized biochip in 1994, the United States has continued to lead the global industrialization of biochips, holding 40% of global biochip technology patents. Furthermore, the North American market accounts for approximately half of the total global biochip market.

According to GIA data, the U.S. biochip market size was $5.2 billion in 2020, accounting for 40.1% of the global market share. China’s biochip market size was approximately $1.1 billion, representing 8.4% of the global market share. Although there is a significant gap between the two countries, China’s biochip market size is projected to exceed RMB 18 billion by 2025, indicating substantial future market potential.

Liu Xiaozhu is optimistic about the development trend of biochips in China: “Biochips can share production lines with traditional IC chip equipment, although some processes differ. It will certainly take time to explore and refine these techniques. While China may lag somewhat in infrastructure and talent, I believe the catch-up will be rapid, and the gap is gradually narrowing.”

According to Weiao Cloud, the company’s core products currently include micro-particle manipulation chip readers, biochips, and cloud data processing systems. Product forms are tailored to different application scenarios. For instance, palm-sized readers and sensors are suitable for on-site law enforcement operations such as customs drug detection. Meanwhile, microwave oven-sized readers are designed for large-scale sample testing in hospitals or testing institutions.

In the field of biochips for particle manipulation technology, MicroAoyun has developed single-channel, dual-channel, 9-channel, and 96-channel chips for use with its instruments.

In Liu Xiaozhu’s business model roadmap, the initial step targets government entities (to-G), as well as research institutions and universities. Currently, Weiao Cloud is engaged in collaborative development with domestic laboratories. For instance, in partnership with a Chinese anti-narcotics academy, the company has enabled on-site rapid detection of drugs such as fentanyl and synthetic cannabinoids using its Weiao Cloud products. Furthermore, Weiao Cloud has collaborated with a Chinese animal disease control center to implement multi-channel, on-site detection scenarios for zoonotic diseases, including foot-and-mouth disease and brucellosis.

“The technology we developed for government clients can also be applied in business-to-business scenarios. However, our ultimate goal is to enter the consumer market, enabling monitoring of common household diseases and food safety testing, thereby becoming a guardian of family health and safety,” introduced Liu Xiaozhu.

“For consumer-facing scenarios, we aim to prioritize the detection of Gram-negative bacteria. Typhoid fever is caused by Gram-negative bacteria. The testing applications for such bacteria are extensive, allowing us to develop a benchmark product.”

Compared with developed countries, China’s annual per capita expenditure on in vitro diagnostics (IVD) is only $7, approximately one-ninth of that in the United States, one-sixth of that in Japan, and one-quarter of that in Western Europe—indicating significant room for growth. This disparity stems primarily from supply-side factors: China’s IVD industry started later, lags in technology, and falls substantially behind international counterparts in both the variety of analytes and the number of testing methodologies. While the United States and Japan offer more than 5,000 test items, China currently provides only 2,000.

In the POCT segment, developed regions also demonstrate significant advantages. Globally, the United States accounts for 47% of the market size, making it the largest POCT consumption region. The European Union follows as the second-largest, with a 30% share. In developing countries such as India, China, and Brazil, the POCT market base is relatively low but holds substantial potential, serving as the primary driver for the expansion of the global market size.

Currently, China’s POCT products are generally in the growth stage, with rapidly expanding market segments including infectious disease testing and cardiac biomarkers. Internationally, diabetes and cardiac biomarker products have already entered the maturity stage, indicating significant room for future growth of these products in China.

“Myocardial infarction is a major cause of death among diabetic patients. We believe that integrating cardiac biomarker monitoring into diabetes testing devices can provide early warnings, thereby improving patients’ quality of life.” Regarding Weiao Cloud’s goals and mission, Liu Xiaozhu has broader aspirations: “The demand for such health management solutions is substantial. Our ultimate aim is to enhance the quality of life and health status of the Chinese population, and even people worldwide.”