Huazhong University of Science and Technology Union Hospital Licenses Novel Colorectal Cancer Imaging Agent for RMB 20 Million

Recently, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, released a public notice on the transformation of scientific and technological achievements, announcing that the hospital intends to“Intestinal Tumor Markers Based on Laser Confocal Endoscopy, and Their Preparation Methods, Usage Methods, and Applications”Patented technology was successfully transferred to industry partners through negotiated pricing, with a transfer amount reaching20 million yuan. The inventor of this patented technology is from the Department of Gastroenterology, Peking Union Medical College HospitalProfessor Lin RongThe team led by.

The patent invention proposed for transfer in this instance belongs to the technical field of imaging agents, with its core lying in the innovative adoption ofDSPE-PEG-FITC NanoliposomesAs a safe carrier, UEA-I, a marker-specific lectin, was successfully used to construct a novel intestinal fluorescent imaging agent.

Colorectal cancer is a common malignant tumor worldwide, and its early diagnosis is crucial for improving patient survival rates. Currently, white-light endoscopy is widely used in clinical practice for gastrointestinal examinations; however, this technique has certain limitations. It is suboptimal in detecting multiple and flat lesions and struggles to accurately determine tumor boundaries. These limitations may affect the completeness of tumor resection, thereby influencing patients’ prognosis.

Combining cancer-specific molecular imaging techniques with optical contrast agents represents a highly promising new direction. This technology leveragesFluorescently labeled molecular probes for specific tumor recognition, which can enhance the contrast between tumor tissue and normal tissue, thereby significantly improving tumor visualization. This is of great significance for achieving early diagnosis and treatment of cancer and improving the therapeutic outcomes of colorectal cancer.

Over the past two decades, emerging technologies such as narrow-band imaging (NBI), ultra-high-magnification endoscopy, and confocal laser endomicroscopy have provided more powerful tools for cancer detection and endoscopic therapy. Narrow-band imaging utilizes light at specific wavelengths to more clearly visualize the microstructures and vascular patterns of the mucosal surface.

Ultra-high-magnification endoscopy provides extremely high magnification, facilitating the observation of subtle cellular changes. Confocal laser endomicroscopy represents a major breakthrough, utilizingFluorescent Contrast Agent, capable of magnifying mucosal tissue by over a thousand times in vivo to achieve real-time imaging at the subcellular level.

However, these advanced technologies still have their respective limitations. Narrow-band imaging (NBI) sometimes struggles to accurately distinguish between tumors and inflammation, potentially leading to misdiagnosis. Ultra-high magnification endoscopy is time-consuming, and diagnostic criteria have not yet been fully standardized. As for confocal laser endomicroscopy, the commonly used contrast agent, sodium fluorescein, results in non-specific staining of all cells, making it difficult to effectively differentiate cancerous cells from normal ones, which poses challenges for real-time diagnosis.

Studies have shown that the combination of confocal laser endomicroscopy with fluorescent molecular probes can be used to identify precancerous lesions and cancer in the colon. Among them,Fucosylation Levelis a key biochemical difference.

Fucosylation refers to the addition of a sugar molecule called fucose to proteins or glycan chains. Studies have shown that the fucosylation patterns in colorectal cancer tissues differ from those in normal tissues, and these alterations may be associated with the onset and progression of cancer.

Ulex europaeus agglutinin 1It is a substance capable of specifically recognizing and binding to glycan structures containing terminal α1-2-linked fucose. Due to its plant origin, it exhibits high safety for human use. Furthermore, it can be promptly aspirated after local endoscopic spraying, minimizing systemic absorption. Therefore, it is regarded as an ideal targeting molecule.

By labeling UEA-I with fluorescent dyes, it is possible to detect differences in fucosylation within tissues, thereby aiding in the differentiation of cancerous regions.

Currently, commonly used labeling dyes include the DyLight series and fluorescein.DSPE - PEG - FITCIt is a novel nanoliposomal material composed of hydrophobic phospholipid layers and hydrophilic polyethylene glycol chains, capable of spontaneously self-assembling into tiny nanoparticles in aqueous environments. The FITC (fluorescein isothiocyanate) conjugated at its terminal end is a classic fluorescent dye.

This structure not only exhibits excellent biocompatibility and stability but also serves as a carrier to achieve targeted delivery. However, whether DSPE-PEG-FITC can successfully conjugate with UEA-I and be ultimately applied for targeted labeling of intestinal tumors using confocal laser endomicroscopy remained previously unexplored.

To address the core challenges in the aforementioned clinical diagnostics, namely poor contrast specificity, difficulty in delineating tumor boundaries, and limited capability for real-time, precise discrimination, there is an urgent need to explore an innovative solution that balances safety, targeting, and high-resolution imaging.

Proposed by the inventionLaser Confocal Endoscopy-Based Intestinal Tumor Marking Technology, with its core advantages and advanced nature lying in the innovative integration ofNanocarrier Technology, Specific Molecular Targeting, and High-Resolution Real-Time In Vivo ImagingThe deep integration of these three elements has led to significant breakthroughs in safety, precision, and diagnostic efficiency.

The sodium fluorescein contrast agent used in conventional confocal endomicroscopy is a non-specific dye that uniformly stains all cells, making it unable to differentiate between cancerous and normal tissues.

The advanced nature of this technology is first reflected in itsPossesses highly specific targeting capability. The molecular probe it employs isGorse Lectin 1, this lectin acts like a “smart key,” capable of precisely recognizing and binding to glycan structures containing specific α1-2-linked fucose that are overexpressed on the surface of colon cancer cells. This binding is based on the fundamental difference in the glycosylation modification known as “fucosylation” between tumor cells and normal cells.

Therefore, when UEA-I labeled with a fluorescent signal is applied to the intestinal mucosa, it selectively accumulates in tumor regions, visualizing lesions at the molecular level and achieving "qualitative" localization of tumors.

Secondly, the remarkable progress in technology is reflected in itsInnovations in Fluorescent Labeling Systems. The present invention does not directly chemically conjugate the dye to UEA-I, but instead introduces DSPE-PEG-FITC nanoliposomes as “fluorescent carriers” for the first time.

DSPE-PEG-FITC consists of microscopic vesicles composed of a hydrophobic phospholipid bilayer and hydrophilic polyethylene glycol chains, which can stably encapsulate the fluorescent dye FITC within their core or conjugate it to their surface.

This nanostructure offers multiple advantages:

First, its polyethylene glycol modification effectively prevents rapid clearance by the body's immune system, thereby prolonging the observation window at the lesion site.

Second, nano-liposomes exhibit excellent biocompatibility, are biodegradable, and have no toxic side effects, thereby addressing the potential biosafety concerns associated with traditional organic dyes.

Third, as a mild and stable carrier, it can bind to UEA-I without compromising its biological activity, forming a DSPE-PEG-FITC-UEA-I complex that ensures the simultaneous and efficient delivery of targeting capability and fluorescent signals.

In terms of clinical application, this technology has driven a transformation in diagnostic paradigms. It integrates the “microscopic magnification” capability of confocal laser endomicroscopy with the “navigation beacon” function of the aforementioned specific molecular probes.

During the examination, the physician may first perform conventional white-light endoscopy. Upon identifying suspicious areas, the marker is sprayed through the working channel of the endoscope. The system is then switched to confocal laser endomicroscopy mode, where a laser of a specific wavelength is used to excite FITC to emit green fluorescence.

At this point, the high-precision confocal scanning device at the tip of the endoscope can capture in real time the mucosal surface and sub-superficial layers up to1,000xmicroscopic images. On the screen, normal mucosa exhibits a regular and well-defined honeycomb-like glandular architecture due to uniform binding of UEA-I; in contrast, adenoma or adenocarcinoma regions display irregular fluorescence distribution, patchy loss of signal, and even disruption of glandular structures, resulting from disordered fucosylation patterns.

This capability to visualize the distribution of specific biomolecules enables in vivo pathological examination, allowing physicians to rapidly determine the nature of lesions at the surgical site and differentiate between inflammation, adenomas, and adenocarcinomas.

This type of"What You See Is the Diagnosis"capabilities have delivered significant clinical benefits. Its non-invasive and precise nature enables more targeted biopsies for small, flat lesions, and in some cases, may even help avoid unnecessary biopsies, thereby reducing the risks of bleeding and perforation.

More critically, it can delineate the precise boundaries of tumors in real time, providing clear guidance for subsequent treatments such as endoscopic submucosal dissection (ESD), ensuring complete tumor resection and reducing the likelihood of recurrence. Experimental data have fully confirmed its superior performance: the technology achieves a sensitivity as high as98.0%, with a specificity of98.9%, its overall diagnostic accuracy surpasses that of many existing advanced fluorescence imaging techniques, providing an unprecedentedly reliable means for the early detection and precise diagnosis and treatment of intestinal tumors.

In response to the urgent need for more specific, convenient, and universally applicable screening methods in the field of early gastrointestinal cancer diagnosis, as well as the limitations of existing endoscopic techniques in dynamically monitoring the evolution of precancerous lesions, research teams both domestically and internationally are systematically planning and developing a series of cutting-edge pipelines centered on confocal molecular imaging technology.

In the international market,GrailThe core products in this field areGalleri, this is a blood-based multi-cancer early detection (MCED) test. By analyzing the methylation profiles of circulating tumor DNA (ctDNA) in the blood, it can identify signals for more than 50 types of cancer from a single blood draw, including lethal cancers such as ovarian and pancreatic cancer that lack routine screening methods.

In the research and development and validation of the Galleri product, Grail has achieved several key milestones. Its detection performance was prominently demonstrated in the Pathfinder 2 clinical study, published in 2025. The study data showed that Galleri achieved a positive predictive value (PPV) of 61.6%, indicating that more than 60% of participants with detected cancer signals were ultimately diagnosed with cancer. Meanwhile, its specificity reached as high as 99.6%, ensuring an extremely low false-positive rate.

More critically, among the incident cancers detected by the Galleri test, 53.5% were at Stage I or II, which are more amenable to treatment, and 74% of these early-stage cancer types are not covered by current routine screening methods. These data collectively confirm the clinical value of Galleri as a robust complement to existing screening systems.

Currently, the Galleri test has entered the commercialization phase in the United States but has not yet received full approval from the U.S. Food and Drug Administration (FDA). GRAIL is committed to promoting this technology as a supplementary tool for routine screening among high-risk individuals aged 40 and older by continuously conducting clinical studies and engaging in commercial partnerships.

In China,Kunyuan GeneMasteredGutSeer Multi-Cancer Early Detection Technology for the Gastrointestinal Tract. This technology stems from research findings published in the internationally renowned journal *Molecular Cancer* in June 2025, marking it as the world’s first multi-cancer early screening technology for gastrointestinal cancers validated by a prospective cohort study.

The core technology of GutSeer lies in its pioneering use of a high-throughput sequencing platform, leveraging an innovatively designed small targeted methylation sequencing panel to simultaneously and accurately capture both the methylation profiles and fragmentomic features of cell-free DNA in blood, followed by integrated analysis using a multimodal artificial intelligence model.

This method not only enables the early detection of various gastrointestinal cancers in a non-invasive manner, but also allows for tissue-of-origin tracing of cancer signals, i.e., determining the likely organ site where the cancer originated.

Of particular importance, this technology is specifically designed for gastrointestinal cancers with high incidence in China, excluding low-incidence cancer types. While enhancing detection efficiency and public health value, it offers the advantages of low cost and a streamlined workflow, making it better aligned with the practical needs of primary healthcare settings and population-wide screening.

Currently, GutSeer technology has moved beyond the stage of pure academic research and entered a critical period for industrialization and commercial promotion. This technology received EU CE certification in 2024, laying the foundation for entry into the international market. In China, Genetron Health is actively advancing the industrialization of this technology and accelerating its domestic regulatory registration process.

Looking ahead to the future of the industry, the diagnosis of early-stage gastrointestinal cancers will increasingly rely on the integration of multidisciplinary approaches and multimodal technologies. Targeted endoscopic imaging techniques centered on specific molecular biomarkers are expected to achieve complementarity and synergy with cutting-edge methods such as artificial intelligence-based image analysis and liquid biopsy.