Jiangsu Cancer Hospital Licenses Novel Gastric Cancer Prognostic Technology Based on Intragastric Methylobacterium Biomarker for RMB 1.2 Million
Recently, Jiangsu Cancer Hospital released a public notice on the transformation of scientific and technological achievements, proposing to license its technologies through non-exclusive licensing.A Gastric Microbiota Biomarker Associated with Gastric Cancer PrognosisPatent licensing to industry partners, with licensing fees ofRMB 1.2 million。
The core of the present invention isUtilizing the Abundance Characteristics of Intragastric Methylobacterium, enabling precise prognosis prediction for gastric cancer patients, while providing novel biomarkers and a technical foundation for the screening of gastric cancer therapeutics and the development of prognostic testing products; this belongs to the field of biodetection technologies related to the diagnosis and treatment of gastric cancer.
As a highly prevalent malignant tumor worldwide, gastric cancer is characterized by insidious early symptoms, strong invasiveness, and a high recurrence rate, with a median survival of less than one year for patients in advanced stages.Prognostic AssessmentIt has become a critical component in the clinical diagnosis and treatment of gastric cancer, creating an urgent demand for efficient and precise prognostic testing technologies. However, existing methods for prognostic assessment of gastric cancer primarily focus onPathological Features, Tumor Markers...unfolds, revealing numerous core pain points that severely constrain the accuracy and practicality of clinical prognostic assessment, while also failing to meet the evolving demands of personalized diagnosis and treatment.
Traditional prognostic diagnostic techniques for gastric cancer face a core bottleneck in precision: On one hand, existing pathological assessments, such as tumor staging and degree of differentiation, can only evaluate the disease at the histomorphological level. They fail to reflect the complex changes within the tumor microenvironment, resulting in significant deviations in predicting patient survival and making it difficult to accurately distinguish between high-risk and low-risk prognostic groups. On the other hand, traditional serum tumor markers, such as CEA and CA72-4, suffer from low specificity and insufficient sensitivity. They are easily interfered with by benign gastric conditions like gastritis and gastric ulcers, and exhibit weak correlations with survival duration and recurrence risk in gastric cancer patients. Consequently, they cannot serve as core indicators for prognostic assessment and have limited clinical utility.
From a clinical application perspective, existing prognostic testing technologies for gastric cancer still exhibit significant practical limitations. Some prognostic assessment methods rely on multi-marker combined testing, involving cumbersome and time-consuming procedures that require specialized pathology analysis teams and high-end equipment. Consequently, these methods are difficult to implement in primary healthcare institutions and lack feasibility for widespread clinical adoption. Other techniques, while operationally simple, only allow for qualitative or semi-quantitative analysis, failing to achieve precise stratification of prognostic risk and thus hindering the formulation of individualized follow-up treatment and monitoring plans. Furthermore, current technologies have not addressed the association between intragastric microbiota and gastric cancer prognosis, overlooking the critical roles of microbiota within the tumor microenvironment in tumor progression and immune regulation. This failure to explore prognostic biomarkers from a novel dimension results in a single-dimensional prognostic diagnosis that cannot comprehensively reflect the actual prognosis of patients.
Furthermore, the existing prognostic diagnostic system for gastric cancer lacks unified clinical application standards. Significant variations in assessment methods and determination thresholds across different medical institutions result in poor comparability of prognostic outcomes. Additionally, the high cost of certain detection technologies and low patient acceptance further limit their routine clinical application. These issues collectively contribute to the current predicament in gastric cancer prognostic diagnosis.“Single dimension, poor precision, and insufficient practicality”In this predicament, there is an urgent clinical need for a novel prognostic biomarker with high specificity and sensitivity, along with its accompanying detection technology, to address the pain points across the entire process from biomarker screening to clinical application, thereby achieving precise prognosis assessment and stratified management for gastric cancer patients.
Addressing the industry pain points of single-dimensional prognostic diagnosis, insufficient precision, and limited clinical utility in gastric cancer, the team at Jiangsu Cancer Hospital has developed aMethylobacteriumA gastric cancer prognosis prediction technology based on intragastric microbiota biomarkers. This technology utilizesDiscovery of Novel Microbiome Biomarkers and Cross-Validation via a Multi-Technological PlatformWith a dual-core architecture, it establishes an integrated solution spanning biomarker screening, abundance detection, and prognostic assessment, thereby overcoming the limitations of traditional evaluations that rely solely on pathological staging and serum tumor markers, and providing a new paradigm for precise prognostic evaluation and personalized diagnosis and treatment of gastric cancer.
InBiomarker ScreeningIn this regard, a groundbreaking breakthrough has been achieved in identifying targets for prognostic assessment of gastric cancer. Traditional methods focus on tumor pathological features (such as TNM staging and degree of differentiation) or serum biomarkers (such as CEA and CA72-4), which fail to reflect the dynamic changes in the tumor microenvironment and are susceptible to interference from benign gastric diseases, thus limiting their prognostic discriminative ability.This technology systematically focuses on the intragastric microbiota for the first time. By performing 16S rRNA sequencing analysis on tissue samples from patients with gastric cancer and chronic gastritis, it precisely identifies *Methylobacterium* as a core prognostic biomarker from the differentially enriched microbial communities.The study found that the abundance of *Methylobacterium* was significantly higher in patients with gastric cancer than in those with chronic gastritis. Its high abundance was significantly associated with shorter patient survival and strongly correlated with adverse pathological features, such as lymphovascular tumor emboli. These findings fill a gap in research on the association between gastric microbiota and gastric cancer prognosis, providing novel scientific evidence for prognostic assessment and the development of potential therapeutic targets.
InCore Testing and ValidationIn this aspect, through multi-dimensional technological synergy, we achieve a triple support of high specificity, high reliability, and mechanistic interpretability.
First, the detection system features high specificity and strong adaptability:Specific primers and probes can be designed, or corresponding antibodies developed, based on the 16S rRNA sequence of *Methylobacterium* to establish a targeted detection system capable of precisely quantifying the relative abundance of *Methylobacterium* in gastric tissues. This abundance metric is significantly correlated with key prognostic parameters, such as overall patient survival and the number of tumor-infiltrating tissue-resident memory (TRM) cells (CD103⁺CD8⁺ T cells). Coupled with optimized reagents for microbial genomic DNA extraction, this approach forms a standardized testing protocol that effectively avoids the interference from benign conditions like gastritis and gastric ulcers, which often affects traditional serum markers.
Second, Multi-Dimensional Experiments Solidify the Scientific Foundation:By integrating 16S rRNA sequencing of clinical samples, multiplex immunofluorescence staining, flow cytometry, and big data analysis from the Asian Cancer Research Group (ACRG) gastric cancer cohort database, we systematically validated the robustness and biological significance of the biomarkers. The results confirmed a significant negative correlation between high abundance of *Methylobacterium* and reduced infiltration of tissue-resident memory T (TRM) cells, suggesting that *Methylobacterium* may influence patient prognosis by modulating the local anti-tumor immune microenvironment, thereby preliminarily revealing a potential microbiota-immunity-prognosis axis.
Third, outstanding prognostic stratification capability:Methylobacterium abundance demonstrates strong discriminative potential in distinguishing populations with different prognostic risks, serving as a quantitative indicator to assist clinical risk stratification (high vs. low) of gastric cancer patients and providing an objective basis for formulating personalized follow-up and intervention strategies.
InClinical Application Adaptabilityaspects, this technology demonstratesSignificant Advantages of Standardization, Multifunctionality, and Translatability. The team has built aNucleic acid sample isolation, high-throughput sequencing (or qPCR), bioinformatics analysis, and result interpretationThis prognostic prediction system, comprising four major modules, features standardized operational procedures and controllable parameters, helping to reduce subjective biases inherent in traditional pathological assessments. This detection platform not only aids in prognostic prediction but also assists in the differential diagnosis of gastric cancer. Furthermore, *Methylobacterium* itself holds potential as a therapeutic target, facilitating the screening of novel immunomodulatory drugs or microbiome-based intervention strategies, thereby achieving “multi-purpose utility from a single biomarker” and enhancing comprehensive clinical value. The employed 16S rRNA sequencing and qPCR technologies are routine methods in current clinical molecular diagnostics; with convenient sample collection and mature testing protocols, they have a solid foundation for widespread adoption in secondary-level and higher medical institutions equipped with the corresponding diagnostic capabilities.
InClinical Value and Industry Developmentaspects,This technology boasts significant advantages and broad prospects.PassMethylobacterium Abundance Detection, enabling precise prognostic stratification of gastric cancer patients, facilitating personalized treatment decisions and dynamic follow-up management, and holding promise for improving clinical outcomes. Meanwhile, based on this biomarker, supporting diagnostic reagents, primer/probe combinations, and standardized kits can be developed, filling the product gap in the field of gastric cancer prognosis detection using intragastric microbiota biomarkers and enriching the portfolio of tumor companion diagnostic products. Its industrial application will also drive in-depth research into frontier areas such as the tumor microenvironment and host-microbiota interactions, demonstrating both significant clinical value and broad potential for industrial translation.
The field of prognostic testing for gastric cancer is undergoing technological upgrades, with microbiota biomarkers emerging as a novel R&D direction following pathological features and serum biomarkers. Research institutions and biotechnology companies both domestically and internationally are strategically positioning themselves around the screening of intragastric microbiota targets, development of detection technologies, and clinical translational applications. Currently, similar studies in the market mainly focus onSingle-bacterial biomarkers, microbial consortium biomarkersTwo major directions have formed a competitive landscape characterized by “research institutions leading in basic research and enterprises driving clinical translation.” There are currently no commercialized diagnostic products targeting Methylobacterium, with the field overall remaining in the stages of technological R&D and clinical validation.
BGILeveraging high-throughput sequencing platforms and multi-omics research capabilities, a comprehensive technical system has been established in the field of cancer prevention and control, covering early screening, auxiliary diagnosis, and prognostic assessment. In the area of tumor microenvironment research, BGI has participated in multiple microbiome-related scientific projects focusing on gastrointestinal tumors, including gastric cancer. By employing 16S rRNA gene sequencing and metagenomic sequencing technologies, these efforts aim to explore the association between microbial community composition in tumor tissues or body fluids and disease progression.
Hebei Medical UniversityThis specialized study addresses the core issue in gastric cancer prognosis, where high rates of recurrence and metastasis in patients with locally advanced gastric cancer (LAGC) lead to suboptimal overall survival. The findings focus on the critical area of early detection of gastric cancer recurrence, targeting the clinical challenge that approximately 50–60% of LAGC patients experience recurrence within two years after initial treatment, by exploring pioneering methods for the early detection of gastric cancer recurrence.