Focus On Liquid Biopsy Technology In Cancer Early Screening Research

Recently, the Ministry of science and technology's key special project "research and development and evaluation of liquid biopsy technology for cancer screening and early diagnosis" was held in Beijing. The project will focus on breaking through the key technologies of liquid biopsy for screening, early diagnosis and treatment of high-risk malignant tumors in China, and build a high-sensitivity, high specificity, high-efficiency and economic early diagnosis technology system for malignant tumor, and develop a completely independent liquid biopsy technology system Intellectual property screening / early diagnosis kit.

Academician He Jie, President of Cancer Hospital of Chinese Academy of Medical Sciences, pointed out that malignant tumor has become the first killer that seriously threatens people's life and health, and most patients who go to the hospital for treatment are in advanced stage. According to the government work report in 2019, efforts should be made to promote cancer screening, strengthen early diagnosis and treatment of cancer, and tackle key scientific problems, so as to solve the livelihood pain points. The start of the project marks that early diagnosis and treatment of cancer has become part of the national strategy.

Professor Wang Jie, director of internal medicine of Cancer Hospital of Chinese Academy of Medical Sciences, pointed out to the reporter of 21st century economic report that there are some bottlenecks in the early diagnosis and screening of cancer, including the lack of existing technical means and the lack of new technologies such as liquid biopsy. We hope to develop a cancer screening and early diagnosis kit with independent intellectual property rights for clinical application. At the same time, Wang Jie hopes that in the future, early screening test should ensure the accuracy and reduce the charging price, so as to improve the accessibility of tumor screening.

In this regard, Wang Sizhen, co-founder and CEO of panshengzi, also said that the key to the research and development of a tumor early screening product should be based on the real clinical needs and strict standards. The technology and products hatched should also have the potential of large-scale application and industrialization, that is, it is accurate, convenient and inexpensive.

The key technology of biopsy needs breakthrough

It is understood that the effectiveness of the project will be verified in a multi center prospective cohort of lung cancer screening for high-risk population in 20 provinces and 120000 communities in China; for digestive system cancer, the effectiveness will be verified by relying on the early diagnosis and treatment project cohort with more than 100000 people in cities and Huaihe River basin.

"This project is the last batch of projects in the 13th five year plan, focusing on common high-risk tumors in China. However, there is a bottleneck in the early diagnosis and screening of tumors. The biggest bottleneck lies in the lack of existing technical means and the lack of new technology such as liquid biopsy Wang Jie pointed out.

Wang Jie expressed the hope that by the end of the project, cancer screening and early diagnosis kits with independent intellectual property rights can be developed for clinical application. "Including our target selection, technology development, clinical verification and product transformation, all guarantee the realization of this goal."

Hu Yunzi, a senior blood biopsy specialist, hopes to introduce a small amount of free DNA to the pre natal cancer specialist. Compared with traditional imaging or other methods, liquid biopsy can detect early tumor markers noninvasively, timely and sensitively to achieve the results of early cancer screening. Therefore, biopsy technology was rated as one of the top ten technologies of the year by MIT in 2015.

"Whether liquid biopsy early screening of cancer can make a breakthrough depends on the three different stages of early cancer screening research and development, that is, whether the research breakthrough of early cancer markers can be achieved, the further verification of biomarkers by prospective research, and finally the witness of large-scale application value in human body." Hu Yunfu pointed out.

This time, panshengzi provided the key technical support for the above-mentioned projects Capsuletm technology can simultaneously detect methylation and multiple gene mutations including SNV, indel, CNV, HBV, etc. with a small amount of blood, capsuletm can perform multiple tests on a sample without sacrificing sensitivity. Its excellent sensitivity and specificity have been verified in the field of liver cancer early screening. "Panshengzi has accumulated rich scientific research achievements in the field of early screening of liver cancer, and will strive to achieve key technological breakthroughs in lung cancer, digestive system cancer and other high-risk cancer species again." Wang Sizhen said.

Professor Liu Qian of Cancer Hospital of Chinese Academy of Medical Sciences cited colorectal cancer as an example. He said that the 5-year survival rate of colorectal cancer between China and the United States is quite different. The reason for the large distance is not that there are great differences in the technology of surgery, radiotherapy, chemotherapy and the use of drugs. The most important reason is that the cancer patients who come to the hospital for diagnosis and treatment are in the early stage The proportion of cases is too low.

"The overall incidence of the United States and other economically developed countries has shown a downward trend year by year, because they have found a large number of early cases and precancerous lesions through standardized and systematic screening, which leads to a big difference between the therapeutic effect and ours." Liu Qian said.

At the same time, Liu Qian pointed out that "early screening of cancer is a very effective way to reduce the incidence and mortality of cancer including digestive system tumors, but there are obvious shortcomings in the current screening methods."

He still takes colorectal cancer as an example, and the current screening methods are divided into two categories: one is non-invasive screening including fecal occult blood test and questionnaire survey. These models are widely used in China, but because the sensitivity and specificity are far from meeting the screening requirements, false positive and false negative patients appear; the accuracy of invasive screening method is relatively high, but the screening rate is not high, because of the patient's feeling If the colonoscopy is a invasive examination method, it will cause intestinal perforation, severe pain and discomfort, arrhythmia and cerebrovascular accident induced by the elderly, and the preparation process is relatively cumbersome.

Improving the accessibility of cancer screening

"In fact, in the research of early screening of cancer, multidisciplinary diagnosis and treatment mode is also involved. It is impossible to rely on a single discipline. We need to establish cooperation between multi-disciplinary tumor related disciplines and interdisciplinary cooperation. At the same time, we also need the participation of scientists who do basic research, and more importantly, we need the participation of some leading technology gene testing companies. This is a large team to jointly explore the nature of cancer, so as to develop good diagnosis and treatment technology and products, which can be applied to our clinical practice. " Wang Jie told reporters in the 21st century economic report that a lot of research is now multi team cooperation.

Wang Jie believes that promoting the accessibility of tumor early screening products includes two important directions: one is the sensitivity and specificity of technology; the other is the issue of price. "1000 yuan is an ideal product."

Wang Sizhen also told the 21st century economic reporter that pan Shengzi's current multi omics research means multidisciplinary research. "If you want to achieve the ultimate goal of early screening, that is, accurate and not too expensive, multidisciplinary participation and multidimensional data analysis are essential. For example, the technology platform of Pansystems actually integrates three different dimensions of genomics, epigenetics (methylation) and proteomics. "

As a matter of fact, compared with the traditional biopsy method, the non-invasive samples such as blood and urine are used to diagnose and evaluate the disease through high-throughput sequencing and other technologies. Moreover, liquid biopsy has the advantages of less side effects, simple operation and re sampling. In addition, the medical cost of liquid biopsy is lower.

Previously, according to Medicare's expenditure analysis of lung cancer biopsy, the cost of ordinary biopsy was $8869. About 20% of biopsy will lead to complications, and the cost of biopsy and treatment of complications will reach $37745. For health insurance, the average cost of a biopsy is $14634. The reimbursement amount of Medicare for the first generation CTC technology is 369 US dollars, and the expenses for the second generation CTC and ctDNA technology are about 800-1000 US dollars.

"The key to the research and development of a tumor early screening product is that it can be widely used in the future. After all, no matter how good the product is developed, it will not create clinical value and social value. The industrialization and commercialization of tumor early screening products can better promote the accessibility of tumor early screening. To achieve industrialization, the technology should be good enough. To a certain extent, it is not only a clear path for clinical application, but also a part of the economic problems Wang Sizhen pointed out.

In Wang Sizhen's opinion, China's commercialized market for early screening and early diagnosis of cancer is still far from the so-called Red Sea. Taking early screening for liver cancer as an example, if only 10% of the population at high risk in China can apply such technology, it will bring about a large scale of commercialization.