Kreep Biotech Advances Next-Generation Pathology with Vertically Integrated mIHC Solutions

In recent years, cancer immunotherapy has made significant progress and was ranked first among the “Top 10 Scientific Breakthroughs of 2013” by Science. Among these advances, breakthroughs in immunotherapies targeting the PD-1/PD-L1 pathway have been particularly notable, establishing them as a key treatment modality for advanced-stage cancers.

However, in actual clinical practice, the response rate to immunotherapy is only 20%–30%, with the majority of patients being insensitive to such treatment. Therefore, identifying patient populations most likely to benefit from immunotherapy and optimizing immunotherapeutic strategies for these specific groups have become focal points of current research. Consequently, the emphasis in diagnostic pathology has shifted from targeted therapy to the study of the tumor immune microenvironment.

Currently, most analytical methods employed in tumor microenvironment research are confined to single immunohistochemistry assays, which cannot simultaneously identify multiple biomarkers. This limitation makes it particularly challenging to accurately analyze the heterogeneity and evolutionary patterns of tumor cells and stroma, resulting in a lack of diagnostic solutions for the tumor microenvironment that directly impacts therapeutic efficacy.

As proteomics and multiplexed protein in situ labeling assays are translated into clinical applications,Multiplex Fluorescent Immunohistochemistry（mIHC）Next-generation pathology (NGP) technologies, represented by advanced technical platforms, enable the simultaneous detection of multiple target biomarkers. By analyzing biomarker combinations and their spatial relationships, these technologies facilitate a more accurate, comprehensive, and efficient assessment of the tumor immune microenvironment., providing a reliable basis for the diagnosis and immunotherapy of tumors.

In the industry, next-generation pathology is also referred to as the next growth window for pathology departments following NGS. Given that next-generation pathology is still in its early stages of development, industry understanding of its technologies and industrial landscape remains limited. This article provides a detailed analysis of the ecosystem across the next-generation pathology value chain, aiming to offer reference insights for the industry.

Pathological diagnosis plays a crucial role in precision medicine. In response to increasingly refined clinical diagnostic demands, pathological examination provides critical information for clinical decision-making regarding surgery, follow-up care, medication, and chemotherapy. However, due to cumbersome workflows, low levels of automation, and a shortage of pathologists, the development of pathology in China has long remained at a relatively low level.

With the continuous advancement of precision medicine and the steady improvement in living standards, public demand for pathological diagnosis in various types of disease screening has been rising year by year, leading to a pronounced imbalance between the supply and demand for pathological diagnostic services.

In this context, multiplex fluorescence immunohistochemistry（mIHC）Technology-Centric Next-Generation Pathology Is Gradually Gaining Attention.

mIHCis a technique used for the simultaneous detection of multiple markers, with its significant advantage being thatFirst, it enables the simultaneous assessment of multiple biomarkers: mIHC can detect multiple biomarkers on the same tissue section, providing more comprehensive information. Second, it offers high sensitivity and specificity; fluorescent signals can be detected at low concentrations with low background noise, ensuring high sensitivity and specificity. Third, it facilitates spatial analysis: mIHC provides information on the spatial distribution of different markers within cells and tissues, aiding in the understanding of cell subset interactions and tissue architecture. Fourth, it allows for quantitative analysis: digital image analysis enables quantification of mIHC results, yielding more accurate and objective data. Finally, it supports multiplex imaging: mIHC utilizes multiple fluorescence channels to simultaneously detect multiple markers, thereby delivering richer information.

Based on the aforementioned advantages,mIHC has broad application potential in clinical settings, including diagnosis, prognostic assessment, and treatment guidance., including prediction of tumor immunotherapy, identification of tumor subtypes, clinical trials and companion diagnostic testing, disease diagnosis and classification, drug development and drug target identification, etc.

With the increasing automation and digitalization of pathology, mIHC will also provide pathologists with valuable and versatile research tools. Advancing the development and widespread adoption of next-generation pathological technologies can not only effectively improve the efficiency and accuracy of pathological diagnosis, save diagnostic time and operational costs, and empower the development of pathology departments, but also enable pathological diagnosis to transcend geographical limitations, thereby addressing the core challenge of the shortage of pathologists.

Currently, next-generation pathology technologies, represented by multiplex fluorescent immunohistochemistry, have made significant progress, with increasing maturity in both instrument stability and reagent accessibility. Domestic companies have already introduced multiplex fluorescent immunohistochemistry technology to provide research services and pharmaceutical company services to downstream players in the industry chain.

However, it is undeniable that the industrialization of next-generation pathology remains in its early stages. It still faces challenges such as limited clinical awareness, an immature industry chain, and a lack of integration between upstream and downstream sectors, which hinder the widespread application of the technology and the mature development of the industry.

The core of current competition lies in how to integrate key links across the upstream and downstream industrial chains on the basis of building technological barriers for next-generation pathology core technologies., thereby promoting the widespread application and industrialization of these technologies. This is also a critical question that all stakeholders in the next-generation pathology industry must urgently address.

With the continuous development of the next-generation pathology industry,Leveraging their respective strengths, NGP enterprises have made it a major development trend to build full-industry-chain service platforms through cross-sector collaborations or by extending their in-house capabilities.

The upstream segment of the next-generation pathology industry chain primarily comprises supply chain vendors providing pathological diagnostic instruments and equipment, reagent raw materials, and data software. The midstream segment consists of technology-driven innovative enterprises such as Kuoran Biomedical Technology (Shanghai) Co., Ltd., which serve as the backbone of the industry, catering to downstream clients including hospitals and medical institutions at all levels, as well as pharmaceutical companies.Research Institutionsand third-party medical testing laboratories, etc., provide matureIntegrated Solutions for Products and NGP。

As one of the first companies globally to drive the industrialization of NGP technology, Kuoran Biomedical initiated clinical translational research on multiplex fluorescent immunohistochemistry in China in 2019. It pioneered the integration of the upstream, midstream, and downstream segments of the multiplex fluorescent immunohistochemistry industry chain, thereby achieving the industrial deployment of NGP through a comprehensive solution for tumor immune microenvironment detection.

On one hand, by extending upstream along the industrial chain, Kuoran Biomedical is actively promoting the regulatory registration and filing of key raw materials, including instruments, software, and antibody-conjugated fluorescent dyes. This strategy not only reduces the cost of multiplex fluorescence immunohistochemistry technology but also strengthens the company’s technological barriers.

It is reported that Kuoran Biomedical has obtained filing and production licenses for 20 products, including triplex, quadruplex, pentaplex, hexaplex, heptaplex, octaplex, and nonaplex multiplex fluorescent chromogenic kits, as well as other immunohistochemistry antibody kits. The company has also secured filing and production licenses for the Krast fully automated immunohistochemistry stainer. With the KR-HT5 fully automated fluorescence pathology slide scanning system poised for full market launch, Kuoran Biomedical’s next-generation integrated pathology solution has formed a complete closed loop.

In the midstream of the industrial chain, Kuoran Biomedical integrates the Kreep multicolor fluorescent staining kit, Krast automated stainer, KR-HT5 high-throughput fluorescent pathology slide scanner, and KRIAS medical pathology image analysis system to form a comprehensive solution for the holistic analysis of the tumor microenvironment.

In addition, Kuoran Biomedical has joined forces with leading pathology centers and research institutions in China to form an industry alliance, driving the development of standardized technical systems and advancing industrialization.

Targeting the downstream segment of the industrial chain, Kuoran Biotechnology’s comprehensive solution for tumor microenvironment analysis provides research services, clinical diagnostic services, and pharmaceutical industry services to hospital pathology departments, third-party testing laboratories, and pharmaceutical companies.

This integrated solution combines staining, imaging, and analysis, while providing professional data mining and analytical capabilities. By quantitatively assessing cellular phenotypes, quantity, and viability, and by investigating spatial relationships between cells, it offers an efficient tool for research on the tumor immune microenvironment, cancer treatment, and prognostic evaluation, demonstrating significant feasibility and value in clinical applications.

Driven by the development trends in medical informatics, hospital pathology departments urgently need to undergo a digital transformation to convert pathological data into high-quality medical resources and promote medical innovation.

However, the penetration rate of digital pathology infrastructure in China’s medical institutions remains at a low-to-moderate level, with industrial development lagging behind implementation progress. This discrepancy stems from a series of challenges confronting the advancement of digital pathology, including inadequate integration of software and hardware into clinical workflows, high costs associated with establishing digital pathology departments, an unclear revenue model, pathological technologies that still fail to fully meet clinical diagnostic requirements, and a lack of unified industry standards.

From this perspective, Kuoran BiomedicalA Comprehensive Tumor Microenvironment Detection Solution Integrating Instruments, Reagents, Software, and Services, with Multiplex Fluorescence Immunohistochemistry as the Core Technological Barrier, it not only helps departments improve the level of precision diagnosis and treatment of tumors, but also achieves interconnectivity of patient diagnosis and treatment data, ensures system and data compatibility, integration, and patient complete report-assisted diagnostic functions, which is conducive to promoting the overall capability building and transformation of digital pathology departments.

In addition,For hospitals, the integrated solution of instruments and equipment + reagents + software + services creates a complete commercial closed loop for pathological diagnosis.It not only streamlines procurement but also offers superior compatibility and convenience during use, making it a highly cost-effective solution for building digital pathology departments.

Currently, next-generation pathology is at a critical stage of transitioning from research to application. The ultimate goal of Kuoran Biomedical Technology (Shanghai) Co., Ltd. is to accelerate the large-scale clinical adoption of this technology, establishing next-generation pathology as the next growth driver for pathology departments following next-generation sequencing (NGS).

Kuoran Biomedical’s comprehensive solution for tumor microenvironment analysis not only opens up new possibilities for pathological diagnosis but also sets standards and provides a model for the next generation of industrialized pathology.

To accelerate the industrialization and large-scale development of NGP technology,Kuoran Biomedical adopts an open-platform strategy,Open the multiplex fluorescence immunoassay platform to third-party medical testing laboratories, research institutions, pharmaceutical companies, and other partners.Establish an industry collaboration alliance to jointly explore the applications of multiplex fluorescence immunoassay technology in scenarios such as drug efficacy prediction, tumor recurrence risk assessment, and drug development, thereby building a technology-application ecosystem.Establish industry consensus to promote the clinical adoption of multiplex fluorescence immunoassay technology.

The translation of a new testing technology from research and development to clinical application involves the assessment of test performance, clinical validation, establishment of quality standards and processes, and the continuous consensus-building among clinical experts.

Looking toward the future, Kuoran Biomedical will continue to collaborate with various industry stakeholders to jointly promote industry consensus and standardization in next-generation pathology, accelerate the industrial implementation of technologies, drive compliant applications across more disease indications, and sustain product optimization, thereby hastening the advent of the golden age of next-generation pathology.

References:

“White Paper on China’s Smart Pathology Industry: Early Signs of Commercialization, Addressing the Disruption and Establishment of Pathology AI”——VCBeat

"White Paper on the Development of China's Smart Digital Pathology Industry in 2022" ——Shanghai Digital Medicine Innovation Center