Recently, the National Bureau of statistics released China’s population changes in 2021: by the end of 2021, China had 267 million people aged 60 and over, accounting for 18.9% of the total population; There are 200 million people aged 65 and over, accounting for 14.2% of the total population. With the continuous deepening of population aging, coupled with the multiple effects of unhealthy living habits and environmental factors, the number of tumor patients continues to increase. According to the data released by IARC, there were 4.57 million new cancers and 3 million deaths in China in 2020.
In order to improve the current situation of cancer diagnosis and treatment and promote the standardized and high-quality development of cancer diagnosis and treatment industry, China has successively issued a number of relevant support policies in recent years. As a cutting-edge technology that can effectively assist in tumor early screening, targeted drug selection and prognosis monitoring, gene detection has become one of the key factors to promote the high-quality development of tumor precision diagnosis and treatment industry. The gene testing industry continues to be favored by capital. Among them, the gene detection market for high microsatellite instability / mismatch repair defect (MSI-H / dmmr) is further expanding.
MSI-H / dmmr solid tumor is one of the indications of Pan cancer approved by FDA. Statistics show that there are more than 320000 patients with microsatellite highly unstable (MSI-H) tumors in China. The huge volume of patients and the increased penetration of testing products also gave birth to a broader testing market. According to The Pacific Securities Co.Ltd(601099) securities’s “one of the unbounded series of innovation: Research on Pan cancer biomarker industry” (hereinafter referred to as “report”), it is estimated that China’s MSI-H treatment and testing market will reach 3.1 billion and 3.9 billion yuan in 2025.
The above report compares and analyzes the three main detection methods for MSI and their corresponding product development: immunohistochemistry (IHC), multiplex fluorescence PCR combined with capillary electrophoresis (pcr-ce) and high-throughput sequencing (NGS). Among them, pcr-ce can directly determine the status of MSI by detecting the number of repeat units of specific MSI sites. The MSI detection panel of five sites is clinically recognized as the gold standard for MSI-H detection, and several guidelines are recommended. At present, only two pcr-cemsi detection kits have been approved for listing in the Chinese market.
In 2021, China’s first MSI detection kit (multiplex fluorescence PCR capillary electrophoresis) that obtained the certificate of class III medical device for microsatellite instability detection was successfully listed. It was independently developed and produced by Tongshu gene. From R & D to production and clinical application, it has been verified by a large number of samples, with stable performance and reliable detection. It is a leading product in the field of MSI detection. Up to now, the market coverage of Tongshu gene MSI testing products has reached more than 80%, and there have been 30000 patient testing cases. While gaining patients, it also effectively promotes the standardized development of tumor gene testing industry and creates a model for the high-quality development of the industry.
Tumor targeted therapy and immunotherapy are becoming the mainstream, and the related immunotherapeutic drugs are also increasing. As an important auxiliary means of accurate diagnosis and treatment of tumor, gene detection technology is also accelerating its clinical application. As a leading enterprise in tumor liquid biopsy gene technology in China, Tongshu gene has made a forward-looking layout and seized market opportunities. In addition to its layout in the field of MSI, Tongshu gene has also launched tumor liquid biopsy solutions such as ctDNA core technology detection platform with high technical barriers, superhrd gene detection panel that can fully cover more than 100 genes, and msings large panel with detection accuracy of 99.7%.
In the face of the strong rise of the tumor gene detection industry, Tongshu gene said that the company focuses on the field of tumor gene technology, continues to dig into the field of a variety of cancer species, expand the boundary of detection technology, and realize the development and application of more accurate and comprehensive tumor gene detection technology. In the future, the company will still actively promote mature technologies and products to better fit the clinical terminal, and accelerate the coverage of unmet clinical needs, so as to enable more human tumor patients to achieve long-term survival.
