Akman Pathology Launches Open Multiplex Immunofluorescence Platform to Advance Clinical Adoption of Tumor Immune Microenvironment Testing

Recently, Shanghai Akerman Medical Laboratory (hereinafter referred to as “Akerman Pathology”), a domestic third-party medical institution specializing in pathological diagnosis, announced the opening of its multiplex fluorescence immunohistochemistry technology platform. In collaboration with healthcare institutions, research institutes, and other partners, Akerman Pathology aims to jointly explore the application of multiplex fluorescence immunohistochemistry in scenarios such as predicting drug efficacy, assessing tumor prognosis, and facilitating drug development. This initiative seeks to foster industry consensus on the tumor immune microenvironment (TIME) and accelerate its clinical adoption.

It is widely recognized within the industry that, as the next growth point for applied technologies in pathology, new-generation pathological techniques represented by multiplex fluorescent immunohistochemistry can significantly advance the development of tumor pathological diagnosis and effectively aid in clinical treatment decision-making.

It is reported that Akerman Pathology, as an active player in the field of tumor immune microenvironment testing in China, has developed a relatively mature solution for such testing.“Leveraging our extensive expertise in immunofluorescence histochemistry accumulated over many years, we have established a technical team comprising more than ten subspecialty pathology experts, along with integrated hardware and software platforms including multiplex labeling staining, spectral imaging, and AI-based image analysis systems, and have developed multiple standardized operational procedures for diagnostic applications.”“Introduced Dr. Ge Junhui, Founder of Akerman Pathology and Chief Physician.”

In recent years, immunotherapy has emerged as a focal point in precision oncology, gradually evolving into a novel paradigm for cancer treatment alongside surgery, chemotherapy, radiotherapy, and targeted therapy. Among these advancements, tumor immune checkpoint inhibitors (ICIs) represent the most prominent area of interest. To date, eight ICI drugs have been approved for marketing by the National Medical Products Administration (NMPA). It is widely recognized within the industry that immunotherapy, particularly ICI-based regimens, offers significant advantages—including superior efficacy, reduced toxicity and side effects, and broad applicability across various cancer types—positioning it to become a cornerstone of future cancer treatment strategies.

From an immunological perspective, the onset and progression of tumors result from the interaction between the tumor and the patient’s immune system. Therefore, immunotherapy relies heavily on research into the tumor immune microenvironment. “Research on the tumor immune microenvironment has emerged as one of the frontier fields in recent years, with thousands of research findings published annually. The tumor microenvironment (TME) refers to the internal environment in which tumor cells arise and reside, composed of various cell types—including tumor cells and immune cells—as well as biomolecules such as regulatory factors. It is closely associated with tumorigenesis, progression, and metastasis, whereas the tumor immune microenvironment specifically focuses on the interplay between immune cells and factors and tumor cells,” explained Professor Zhang Huizhen, Chief Physician in the Department of Pathology at Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University, in an interview with reporters.

Currently, immune checkpoint inhibitors do not benefit all target patients. In clinical practice, when these agents are used as first-line therapy, companion or complementary diagnostics are required to detect biomarkers for predicting therapeutic efficacy, thereby avoiding ineffective treatment as much as possible. Commonly used diagnostic biomarkers include mismatch repair deficiency (dMMR), PD-L1 protein expression, and tumor mutational burden (TMB). However, these markers have their own limitations. Scholarly studies and statistics indicate that even when these markers are positive, more than half of patients still fail to derive benefit. With the growing demand for precision medicine, there is an urgent clinical need for more effective biomarkers. The tumor immune microenvironment has thus become a prominent focus of research. If advanced technical approaches can be employed to elucidate the composition and dynamic characteristics of the tumor immune microenvironment, it will undoubtedly represent a significant advance in immunotherapy.

Professor Zhang Huizhen believes that,An increasing body of research indicates that elucidating the interplay between tumor cells and immune cells through the lens of the tumor immune microenvironment (TIME) provides a more comprehensive and precise assessment of therapeutic benefits from immune checkpoint inhibitors. Classifying tumors based on their immune microenvironment can better guide clinical immunotherapy and prognostic evaluation. Furthermore, assessment of the tumor immune microenvironment holds promise as a supplement to the TNM staging system for certain cancers.

In fact, there has long been a lack of mature technologies for detecting the tumor immune microenvironment in clinical practice. While conventional techniques such as immunohistochemistry, flow cytometry, and gene expression profiling can evaluate the tumor immune microenvironment to some extent, these methods remain immature and fail to adequately reflect the in situ growth environment of tumors. For instance, they struggle to effectively interpret the in situ status of immune cells within tumor tissues and their spatial relationships with tumor cells. In contrast, multiplex fluorescent immunohistochemistry is widely favored by the industry and is poised to become a cornerstone technology for the detection of the tumor immune microenvironment.

““Multiplex fluorescence immunohistochemistry demonstrates significant advantages in the assessment and analysis of the tumor microenvironment.”Dr. Han Yang, a pathology expert at Akerman and principal investigator of the tumor immune microenvironment platform, stated,Multiplex Fluorescent Immunohistochemistry: An Amplification and Advancement of Traditional ImmunohistochemistryMultiplex fluorescent immunohistochemistry (mIHC) represents an amplification and refinement of traditional immunohistochemistry. Based on the fundamental principle of antigen-antibody binding, it employs tyramide signal amplification (TSA) technology to perform immunofluorescent staining for multiple targets on a single tissue section through iterative staining rounds. This approach enables whole-slide scanning without the need for image stitching. Preliminary validation has demonstrated that the high intensity and stability of fluorescent signals significantly enhance the detection sensitivity for certain markers, facilitating the analysis of low-abundance samples.“By leveraging their expertise in tumor morphology, pathologists can better optimize the application of analytical software. The technical characteristics of multiplex fluorescent immunohistochemistry, combined with the nature of pathological practice, allow for more objective qualitative and quantitative assessment of various cell types. This provides a comprehensive visualization and statistical analysis of the components within the immune microenvironment across different tumor regions, thereby assisting clinicians in precisely identifying patients likely to benefit from immunotherapy, ultimately saving treatment time and costs for patients.”

A 2019 meta-analysis published in JAMA Oncol also partially corroborated the aforementioned assertion. This study compared the performance of various biomarkers in predicting the efficacy of immune checkpoint inhibitors, including PD-L1 expression, tumor mutational burden (TMB), gene expression profiling (GEP), and the tumor immune microenvironment assessed by multiplex immunofluorescence histochemistry. The results indicated that analysis of the tumor immune microenvironment using multiplex immunofluorescence histochemistry as a biomarker had the highest predictive value.

In response to the urgent clinical demand for tumor immune microenvironment detection, Shanghai Akerman Medical Laboratory Co., Ltd. has leveraged its extensive expertise in pathological diagnosis to establish a multiplex fluorescence immunohistochemistry platform, and subsequently developed a comprehensive solution for tumor immune microenvironment analysis using this technology.

“The tumor immune microenvironment is currently a focal point of clinical research and application, while multiplex immunohistochemistry is regarded as the next-generation pathology technology. The integration of these two approaches will undoubtedly bring about a significant leap forward in pathological diagnosis,” stated Dr. Ge Junhui. “Although Shanghai Akerman Medical Laboratory Co., Ltd. has been strategically positioned in this field for many years, broader participation from medical institutions is essential to accelerate the widespread adoption of this technology and ensure that clinical patients benefit from it as soon as possible.”Thus, it was a natural progression for Dr. Ge Junhui to position the multiplex fluorescence immunoassay technology platform as an open platform.