On November 20, the human SDC2 gene methylation detection kit (fluorescent PCR method) belonging to three types of in vitro diagnostic reagents independently developed and produced by Guangzhou Kang Liming Biotechnology Co., Ltd. (hereinafter referred to as "Kang Liming Bio") Name: "Chang'an Heart") officially approved by the State Drug Administration.

Fecal DNA testing has a natural advantage for detecting intestinal tumors, because normal adults have epithelial cells falling off into the intestinal lumen every day and excreted with feces, while colorectal cancer cells are abnormally proliferating, cells and cells or cell basement membranes. Factors such as decreased adhesion are more likely to fall off than normal epithelial cells. Therefore, the feces of patients with intestinal tumors will contain a large number of cells and cellular components that carry information on intestinal cancer lesions that have fallen off the surface of the intestinal tumor. This information can be interpreted by special detection methods.

"Chang'an Heart" is mainly based on independent innovation of high detection performance PCR patent technology for qualitative detection of methylation of SDC2 gene in human stool samples. This product is the first detection product of fecal colorectal cancer deoxyribonucleic acid methylation marker screened in Chinese population for the diagnosis of colorectal cancer. It can provide more colorectal cancer to clinicians and subjects. The choice of an auxiliary diagnostic method.

“Chang'an Heart” started a multi-center clinical trial in July 2017, using the gold standard for enteroscopy and/or pathology as a control method. After clinical trials of 1213 effective cases by the Third Clinical Laboratory of the Sixth Hospital of Sun Yat-sen University, Nanfang Hospital of Southern Medical University and Shandong Cancer Hospital, the kit can be stably tested with a specificity of 97.85%. Out of 84.22% of colorectal cancer, the detection rate of clinically treatable stage I/II intestinal cancer was 86.35%, and the kappa value reached 0.85.

"Chang'an Heart" project team PI, former vice president of Sun Yat-sen University, honorary president of the Sixth Hospital affiliated to Sun Yat-sen University, and honorary leader of the Chinese Medical Association Anorectal Surgery Group Professor Wang Jianping said: "The incidence of colorectal cancer in China along with people's living standards It has been increasing year by year. Now China's developed regions are the second most common malignant tumors and a major disease threatening the health of our people. However, the development of colorectal cancer is relatively slow and can be cured through early detection. It is prevention."

Kang Liming Bio focuses on the development, production and sales of early diagnosis products such as the “Chang'an Heart” fecal DNA colon cancer detection kit, and provides corresponding testing services. Its company headquarters is located in the accelerator of science and technology enterprises in Guangzhou High-tech Industrial Development Zone, covering an area of ​​more than 6,000 square meters, including R & D laboratory, GMP production workshop, comprehensive office area, third-party medical inspection laboratory. In addition, Tianjin, Wuhan, Jinan and other places are also building a third-party medical testing laboratory, a total of 8,000 square meters. Among them, the laboratories in Guangzhou and Tianjin have passed the examination and obtained the medical institution license and gene amplification license.

The approval of “Chang'an Heart” has benefited from years of unremitting research and development practice. Dr. Zou Hongzhi, the founder of Kang Liming Biology, started the research on fecal gene detection in Mayo Clinic in the United States in 2002. The similar products developed by the United States have been approved by the FDA and incorporated into the US guidelines for colorectal cancer screening. One of the main methods of screening for rectal cancer. Although foreign products have been widely recognized, Dr. Zou has not copied to China. “Chang'an Heart” is the new result of the five-year localization of the team after Dr. Zou returned to China.

Dr. Zou said that there is no advantage in foreign fecal genetic testing products for the detection of intestinal tumors. In our early development of "Chang'an Heart", what we thought was not how to imitate American products, but to do it with the attitude of leading the previous results, that is, to design according to the genetic background and living habits of Chinese people. The products, such as the choice of markers and the design of the sampling device, are preferred in accordance with Chinese standards.

After a lot of screening and optimization work, Dr. Zou led the team to successfully transform the “Changan Heart”. In March 2017, “Chang'an Heart” was recognized as an innovative medical device product by NMPA; in July 2017, “Chang'an Heart” was included in the National Key Research and Development Program of the Ministry of Science and Technology “Chinese Colorectal Cancer Screening and Intervention Technology Research (2017YFC1308800)”.

It is reported that "Chang'an Heart" has also cooperated with dozens of large-scale top three hospitals in China to carry out research and clinical verification work. In more than 5,000 prospective research data, "Chang'an Heart" detected more than 70 cases of early intestinal cancer.

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