The world's first liver cancer diagnostic kit came out in Shanghai

Source: ScienceNet 2018-01-29 today, at the "innovation mode forum of" medical research production "of Zhongshan dunhui new diagnosis and treatment technology transformation center held in Zhongshan Hospital Affiliated to Fudan University", news was uploaded: academician of the Chinese Academy of Sciences, Professor Fan Jia, President of Zhongshan Hospital, and Professor Zhou Jian, vice president, led the team to achieve two major research and development achievements in the field of liver cancer diagnosis and treatment The team developed "7 kinds of micro RNA liver cancer detection kits" and collected 0.2ml plasma to improve the early diagnosis rate of liver cancer; the team developed "fully automatic circulating tumor cell sorting and detection system", which can improve the recurrence and metastasis of liver cancer and the prediction effect of diagnosis and treatment effect It is reported that both of these achievements have completely independent intellectual property rights, and technology transfer may be realized, or a new chapter in the diagnosis and treatment of liver cancer may be opened Liver cell carcinoma (HCC) is one of the most common malignant tumors in the world The newly diagnosed HCC accounts for 55% of the world's cancers every year in China, and the mortality rate ranks the second among all the malignant tumors Existing data statistics show that the 5-year survival rate of advanced liver cancer is close to 0 After radical surgery, the 5-year survival rate of early liver cancer can reach more than 60% But the reality is very cruel: the onset of liver cancer is hidden, and there is no specific symptom in the early stage About 80% of patients have entered the late stage in the first diagnosis, and lost the opportunity of radical surgery; even if radical surgery is carried out, 60% to 70% of patients still have metastasis and recurrence within 5 years; the overall 5-year survival rate of liver cancer patients is only about 7% It is of great significance to improve the diagnosis and treatment of liver cancer After nine years of research, fan Jia led the team to select early liver cancer diagnostic molecular markers composed of seven miRNAs from patients' plasma (at present, the molecular marker model has been patented by China, Japan and South Korea) Only 0.2ml plasma was collected by the kit, and the sensitivity and specificity of the kit were more than 80% Fan Jia told reporters that about 30% to 40% of clinical AFP negative patients, it is difficult to find intrahepatic tumor by conventional means With 84% sensitivity and 88% specificity, AFP negative HCC patients can be screened out The application of the kit, blood test and imaging examination can significantly improve the diagnostic efficiency of various clinical types of liver cancer, including small liver cancer less than 2 cm, so as to reduce the rate of missed diagnosis and misdiagnosis The real-time and dynamic monitoring of the therapeutic effect of liver cancer with the kit can timely warn the occurrence of tumor recurrence and progression The performance of the kit is about 35% higher than that of the traditional alpha fetoprotein detection As for the convenient collection method, it will play an important role in the whole treatment and follow-up process of patients The clinical can timely reflect the treatment effect and early-warning tumor progress through multiple blood tests, so as to reduce the dependence of patients on traditional imaging examination It is reported that the application of the kit has completed multi center clinical verification and passed the certification of the State Food and drug administration In August 2017, CFDA obtained the class III device registration certificate and production license From this year, it will be popularized through clinical application in 20 provinces and centers nationwide, and become a more effective tool for clinicians to diagnose liver cancer and monitor the prognosis and curative effect of patients Experts said that with the popularization of the kit, the overall 5-year survival rate of patients with liver cancer in China could be increased to 20% to 30%, and the mortality rate could be effectively reduced The key problem is the low survival rate and high recurrence rate of liver cancer patients In recent years, many domestic and foreign scholars agree that free circulating tumor cells (CTC) in peripheral blood are the "seeds" of tumor metastasis and recurrence, and play an extremely important role Academician fan Jia and Professor Zhou Jian's team first tested "circulating stem cell like liver cancer cells in peripheral blood" in the world, and found that circulating stem cell like liver cancer cells can be used as a new index to predict recurrence after hepatectomy The team has independently developed a variety of CTC sorting and detection technologies, and has successfully developed the world's first prototype machine and detection kit of "fully automatic circulating tumor cell sorting and detection system", relevant core technologies have obtained 3 invention patents, and applied for 5 invention patents The system can realize one-stop automatic sample processing from whole blood sample to CTC, including blood centrifugation, liquid processing, CTC capture, cell staining and other steps; the sensitivity of CTC capture can reach more than 90%, 24 samples can be processed in 8 hours, and the CTC cells captured can also be used for downstream single cell sequencing analysis, revealing the gene mutation and expression spectrum of each CTC This provides a good platform for early diagnosis and treatment of liver cancer, effective prediction of recurrence, efficacy monitoring and stem cell research On the same day's forum, Zhongshan Hospital Affiliated to Fudan University and Shanghai dunhui medical science and Technology Development Co., Ltd signed the "technology patent transfer agreement" and "technology patent license agreement" to transfer or license 8 core invention patents generated in the research and development process with RMB 30 million The derivative product "chimerax-120tm circulating tumor cell automatic sample processing and detection system" is preparing for CFDA registration and application It is reported that at present, only the U.S cellsearchtm system has obtained the registration and listing license from the regulatory authority, which is the international gold standard for CTC testing Compared with cellsearchtm system, this system has the advantages of higher automation, higher detection sensitivity, more CTC sorting modes and better CTC downstream analysis compatibility At the forum, academician fan Jia introduced the experience of opening up the innovation chain of "medical research production" and the industrial chain to realize "Zhongshan intelligent manufacturing" It is understood that Zhongshan Hospital, through cooperation with the innovative medical enterprise Shanghai dunhui medical science and Technology Development Co., Ltd., established the new technology transformation center of Zhongshan dunhui diagnosis and treatment, realized a highly unified four point one-line cooperation model from hospital transformation platform research and development enterprise production laboratory application, and developed a series of new diagnosis and treatment technologies with independent intellectual property rights Through the establishment of a new model of "medical research production", the key links of medical innovation, transformation and industrialization are opened, and the seamless integration of innovation chain and industrial chain is realized This new model will not only accelerate the clinical transformation of China's advanced scientific research achievements, but also effectively enhance the core competitiveness of China's domestic new diagnosis and treatment technology to the international advanced ranks The Zhongshan innovation mode of "medical research production" provides useful experience for applying the most advanced biomedical technology to the research of disease essence, exploring new methods of diagnosis and treatment, and cooperating with enterprises to transform the scientific research achievements "landing" into medical products that can be applied to clinical and serve the vast number of patients.