1. Introduction to the Project

1.1 Introduction to technical achievements

The project focuses on some issues such as poor sensitivity and specificity in the diagnosis of gastric cancer, developing and researching a gastric cancer specific marker detection kit, and inventing a new method for detecting SCTAG in gastric cancer. By now, the tumor biomarkers of this project has obtained 2 domestic invention patents and is currently applying for international invention patents.

1.2 Technical analysis and advantages

1.2.1 Core technical analysis

The expression of SCTAG tumor antigen is elevated in gastric cancer, liver cancer, esophageal cancer, lung squamous cell carcinoma, osteosarcoma, colorectal cancer, ovarian cancer, endometrial cancer, cervical cancer, and other tumors. The detection rates of its mRNA and protein expression levels in gastric cancer are as high as 96.2% and 81.7%, respectively. Through immunohistochemical staining, it was found that the protein expression level of SCTAG is related to the degree of tumor cell differentiation, clinical stage, lymph node and nervous system invasion (the current best tumor marker immunohistochemical staining positive rate is 69.58%). Therefore, it is preliminarily determined that SCTAG may be a novel serum tumor marker for gastric cancer.

1.2.2 Technological innovation and advantages

SCTAG has the characteristics of high sensitivity, specificity, and broad-spectrum, and its detection rate in gastric cancer is much higher than that of existing detection kits. It is a high-quality tumor marker that has not been seen in the current market and literature reports. By now, the PCR and immunohistochemistry technologies developed by the project technology R&D team have matured, and the expression level of SCTAG has been tested in about 200 samples, which has a higher maturity and detection stability compared to the similar products at home and abroad. At present, there are no clinical gastric cancer diagnostic application products and basic research work related to SCTAG internationally, except for the R&D team of this project. The development of SCTAG-related diagnostic products has high originality in both theoretical level and product development.

Currently, two invention patents have been approved. One of them is a PCR reagent kit for diagnosing gastric cancer. The patented invention has a positive detection rate of 93.8% for tumor tissue and 60.4% for adjacent tissues. Another application is the use of SCTAG in the preparation of diagnostic kits for gastric cancer. The positive rate of serum SCTAG protein in the diagnosis of gastric adenocarcinoma patients can reach up to 93.5%, and the positive rate of early gastric cancer patients is 96.3%.

1.3 Main products and applications of technical achievements

The main product of the project’s technical achievements is the SCTAG gastric cancer detection kit, which can be used for outpatient diagnosis and screening of physical examination populations.

1.4 Stage of technological achievements

The technical achievements of the project are in the pilot stage.

1.5 Technical team

The team leader is currently the Director of the Nanomedicine Transformation Research Center, and has been awarded titles such as one of the Young Top Talents in the “Ten Thousand Talents Plan” by the Organization Department of the Central Committee, Chinese Young Female Scientists, Leading Talents in Health Research in Jilin Province, and one of the Eighth Batch of Top Innovative Talents in Jilin Province. She has participated in or led national key research and development programs, National Natural Science Foundation of China general projects, Top Ten Thousand Talents projects, and Jilin University high-level scientific and technological innovation team construction projects. She has published 28 research papers in journals such as Nanotechnology, Nano Lett, Anal, Chem, etc., with a total IF of approximately 238.7. The team has introduced 3 research teachers, 1 attending physician, and more than 10 postdoctoral, graduate, and technical personnel. The team members are proficient in experimental skills such as oncology, immunology, and molecular biology, and have a solid foundation in cell culture, animal model construction, antibody preparation, and tumor marker detection. Relevant achievements have been published in high-level journals.

The team has multiple comprehensive laboratories, including the molecular biology laboratory, immunology laboratory, cell therapy laboratory, and nanomaterials research laboratory (with a total area of 350 square meters), which have laid a solid talent and platform foundation for the smooth development of scientific research in the team.

2. Market Potential Analysis

The global cancer screening and diagnosis market is steadily growing, with the Chinese market growing faster than the global market. According to GRAND View Research, the Chinese cancer screening and diagnosis market reached $6.5 billion in 2021 and is expected to grow at a compound annual rate of 11.3% in the future, which is much faster than the global growth rate.

In 2018, according to the data of GRAND View Research, the top three diseases with the largest proportion in the global cancer diagnosis market are breast cancer, lung cancer and colorectal cancer. According to Frost&Sullivan’s data, the market size of colorectal and gastric cancer screening in China will rapidly expand: it is expected that the market size of colorectal cancer screening will have reached 19.8 billion yuan by 2030; it is expected that the market size of gastric cancer will have exceeded 15 billion yuan and reached 15.7 billion yuan by 2030.

Due to the fact that the vast majority of gastric cancer has no obvious symptoms in the early stages, it is easily overlooked. Therefore, early diagnosis of gastric cancer is particularly important. The commonly used diagnostic methods in clinical practice include serum biomarker testing, imaging testing, and histopathological diagnosis. However, so far, projects related to the diagnosis of gastric cancer have mainly focused on molecular diagnosis, and the sensitivity and specificity are not ideal. The research on tumor biomarkers closely related to diagnosis and treatment, which identify individual characteristics, is particularly insufficient.

The detection of serum biomarkers has the huge advantages of small trauma, low cost, and strong repeatability, especially suitable for large-scale population census, and has always been a research and competitive hotspot in the international and domestic diagnostic industry. Therefore, the development of gastric cancer specific biomarker detection kits is still an urgent need for the diagnosis and treatment of gastric cancer, and an important means to address the deterioration and even death of gastric cancer.

3. Financing Needs and Stage Goals

The project is planned to raise 30 million yuan for the subsequent clinical trial development of the product. It is mainly for the approval of rapid pathological diagnostic reagent kit numbers, clinical validation of various tumor markers, industrialization of SCTAG reagent kits, and development of new diagnostic methods.

4. Analysis of Technical Achievements and Benefits

4.1 Economic benefits

The market value of the technical achievements of the project is 60 million yuan.

4.2 Social benefits

After the commercialization of the technical achievements of the project, the sensitivity and specificity of gastric cancer clinical diagnosis can be improved in clinical diagnosis, and it can be widely used in outpatient patient diagnosis, screening of physical examination population, as well as remote mountainous areas and medical assistance work. This is conducive to improving the early diagnosis and detection rate of gastric cancer, improving the survival and recovery rate of gastric cancer patients, and providing support for the “Healthy China Strategy”.

5. Contact Method

Contact person: Xu Wan 

Tel: 13756652164