GeneTruth Biotech: Targeting the 'Golden Niche' of Immunoassay 4.0 with Cutting-Edge Flow Fluorescence Technology

As 2019 drew to a close, it was a year worth celebrating for Zhizhen Biology. In 2019, Zhizhen Biology’s B and C series five-part differential hematology analyzers with combined infection marker testing, as well as the CytoPOC flow cytometer, received regulatory approval for market launch and sales. Additionally, Dr. Xu Bing joined Zhizhen Biology as Chief Technology Officer (CTO) in the same year.

According to Ma Yongbo, founder of Zhizhen Biotech, Dr. Xu Bing’s joining has infused Zhizhen Biotech with stronger R&D capabilities against the backdrop of a scarcity of top-tier immunodiagnostic R&D talent in China.

Previously, Xu Bing worked at Beijing Mindray Medical Electronics Research Institute Co., Ltd. and Kemeng Diagnostics, among other companies. He led the successful development of a comprehensive solution for the world’s most advanced hematology analysis systems, which represents a truly high-end product within China’s in vitro diagnostic (IVD) industry. This achievement enabled Mindray Medical to transition from low-end hematology analyzers to the high-end segment and expand into international markets.

As one of the few in vitro diagnostic (IVD) companies in China to have deployed flow fluorescence technology, Zhizhen Biology secured investment from Honghui Capital and Mifang Capital in its first round of financing. Looking ahead, Zhizhen Biology is poised to achieve full in-house production of multicolor fluorescently encoded magnetic beads and to develop a broader range of hematology analyzers, flow cytometers, flow fluorescence products, and associated reagents.

Amid a Landscape Where Flow Cytometry Fluorescence Technology Is Dominated by Foreign Companies, How Can Zhizhen Biotech Break Through? VCBeat (WeChat ID: vcbeat) Interviewed Ma Yongbo, Founder of Zhizhen Biotech.

Before founding Zhizhen Biology, Ma Yongbo held positions at Mindray, CapitalBio Technology, and other leading in vitro diagnostics (IVD) companies, where he was responsible for the R&D of various products, including biochemical analyzers, hematology analyzers, and flow cytometry systems. As a veteran in the IVD industry, he is highly optimistic about the prospects of flow fluorescence technology.

First, it is due to the technological superiority of flow fluorescence.

Looking back at the development history of clinical laboratories in China, testing capabilities were very limited in the early years after the founding of the People's Republic, with manual colorimetric analysis being the predominant method. Subsequently, enzymatic methods replaced traditional chemical techniques across a broad range of applications. Solid-phase enzyme immunoassay (ELISA), offering advantages such as the absence of radioactive contamination, brought the era of radioimmunoassay (RIA) to an end. Furthermore, chemiluminescent immunoassay has elevated assay sensitivity and precision to new heights.

It can be said that the evolution of immunoassay methodologies has progressed from enzyme-linked immunosorbent assay (ELISA) to plate-based chemiluminescence, then to tube-based chemiluminescent magnetic beads, and finally to electrochemiluminescence. Flow fluorescence technology represents a further upgrade in immunoassay techniques.

Flow cytometry-based fluorescence assay integrates multiple technologies, including fluorescently encoded microspheres (liquid suspension arrays, liquid-phase chips), laser analysis, flow fluidics systems, and high-speed data processing, featuring high throughput, high sensitivity, and parallel detection capabilities.

In the context of immunoassays, chemiluminescence can detect only one analyte at a time, whereas flow fluorescence technology can theoretically detect more than 500 analytes simultaneously. Multiplex testing aligns with the development trends of in vitro diagnostics (IVD) in China; it reduces patient waiting times and laboratory staff workload during multi-analyte testing, while also decreasing the consumption of reagents and serum, thereby lowering testing costs.

“Flow fluorescence multiplex testing, as a methodological upgrade to chemiluminescence, is the most universally applicable platform for multi-analyte simultaneous detection in immunoassay scenarios,” said Ma Yongbo.

In the field of chemiluminescence, domestic companies have clustered their investments, emerging in large numbers. However, few have truly reaped the benefits. In contrast, flow fluorescence technology presents a very high barrier to entry. Complete product solutions, including liquid chip technology, are mastered by only a handful of international companies, such as BD and Luminex. Currently, TransMedi, a representative Chinese company in flow fluorescence, has developed flow fluorescence products for clinical laboratories and health check-up scenarios through collaboration with Luminex.

Second, the market potential of flow cytometry-based fluorescence technology is enormous.

Currently, the immunodiagnostics market is the primary driver of growth in the in vitro diagnostics (IVD) industry and is often referred to as the “golden segment.” Approximately 70% of the immunodiagnostics market has adopted chemiluminescence technology, which is growing at a compound annual growth rate (CAGR) of around 25%. The chemiluminescence market is largely monopolized by foreign companies such as Roche, Abbott, Beckman Coulter, and Siemens, with domestic enterprises holding only about 10% of the market share. This indicates substantial potential for import substitution.

Flow fluorescence technology offers greater technical and cost advantages than chemiluminescence, and is poised to capture a share of the “golden niche” of immunoassay diagnostics.

In addition to its fully automated flow fluorescence platform, Zhizhen Bio has two other major product lines: hematology analyzers and flow cytometers.

Currently, ZhiZhen Bio’s POCT flow cytometer, CytoPOC, has obtained regulatory approval and is commercially available. It can be deployed in county-level hospitals, clinical departments, and the disease control market for applications such as reproductive testing, cytokine detection, and CD4 cell counting.

In China, both the industry and technology for flow fluorescence are still in their early stages, with the primary customers for flow fluorescence products remaining tertiary hospitals and research institutions.

In recent years, with the gradual implementation of the tiered diagnosis and treatment policy, the primary healthcare market has become a rapidly growing segment within the in vitro diagnostics (IVD) industry. In this market, Zhizhen Biology’s B and C series hematology analyzers have achieved rapid market penetration.

Common complete blood count (CBC) analyzers on the market include three-part differential and five-part differential hematology analyzers. Among these, five-part differential hematology analyzers can classify white blood cells into five types—monocytes, lymphocytes, neutrophils, eosinophils, and basophils—based on cellular characteristics such as volume, complexity, and granularity. They also provide alerts for abnormal cells, thereby reflecting the true status of peripheral blood.

In contrast, three-part differential hematology analyzers can only classify white blood cells into three categories based on cell volume and are unable to count all five types of white blood cells.

Currently, three-part differential hematology analyzers have been widely adopted in primary healthcare institutions across China, and upgrading these devices has become a major market trend.

Ma Yongbo stated, “Our hematology analyzers differentiate themselves through the combination of five-part differential counting and ‘X’ infection marker joint testing, offering a significant competitive advantage over standard five-part differential products. Under the policy restricting antibiotic use, joint testing of five-part differential counts with infection markers such as C-reactive protein (CRP) has become the norm. There is an urgent demand for additional joint testing parameters, including serum amyloid A (SAA) and procalcitonin (PCT). It is a major trend for traditional hematology analyzers to be replaced by those capable of joint testing with infection markers. Meanwhile, national policies require primary healthcare institutions to equip themselves with five-part differential hematology analyzers and flow cytometers, driving substantial procurement volumes in the market.”

A decade ago, a large number of in vitro diagnostics (IVD) companies missed the window for chemiluminescence immunoassay (CLIA). By the time they entered the CLIA market after the technology had become widely disseminated, the opportunities had already vanished. As a veteran deeply rooted in the IVD industry for many years, Ma Yongbo understands that true competitiveness lies in the capability to seize opportunities.

“Our team possesses relatively comprehensive technical capabilities, a rarity in China. Meanwhile, our team boasts extensive R&D experience and strong cohesion. ZhiZhen is poised to become the first enterprise in China to achieve breakthroughs in flow fluorescence technology. We aim to accelerate the deployment of this technology in domestic settings, thereby benefiting more patients.”

Currently, Zhizhen Biologics is undergoing a new round of external financing. Based on its optimistic outlook for Zhizhen’s development prospects, the Science and Technology Bureau of Yizhuang Development Zone has also provided Zhizhen with tens of millions of yuan in scientific and technological fund support.

Interested parties, please contact the financing assistant Xiaoyun: DongMai_Investent

Reference Article:

Medical Frontiers: A Novel Flow Cytometry Fluorescence Detection Technology

https://www.cn-healthcare.com/articlewm/20181211/content-1042808.html