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Medical Network February 6th On February 5th, the National Health and Family Planning Commission released the latest achievements of the national science and technology major projects in the field of medicine and health. The two IVD products were recognized as major innovations and major breakthroughs.
The two IVDs were confirmed by the Health Planning Commission
The latest achievements of the major special projects issued by the Health Planning Commission involved a special project for the creation of new drugs and a special project for infectious diseases. The latest achievements of the infectious diseases project are the results of two IVD research and development.
Both of these IVDs are test kits, which are undertaken by Zhongshan Hospital affiliated to Fudan University. The report of the Health Planning Commission stated:
Zhongshan Hospital affiliated to Fudan University has made major breakthroughs in the early diagnosis and treatment of liver cancer and predicting recurrence and metastasis. Two of the world's first technologies with completely independent intellectual property rights have been listed or contracted separately.
The "seven micro-ribonucleic acid liver cancer detection kits" developed by the company can accurately diagnose liver cancer by collecting only 0.2 ml of plasma, and fill in the gap in the clinical method for effectively monitoring alpha-fetoprotein-negative liver cancer. The sensitivity and specificity are both More than 80%.
Another "automated circulating tumor cell sorting detection system" successfully developed the world's first prototype and test kit based on the "stem cell-like circulating liver cancer cells in peripheral blood" detected for the first time in the world. Cooperation to achieve results transformation.
Medical device company participation
In fact, this is an innovative research and development in which medical device companies participate in joint promotion. This is a medical device company based in Shanghai.
It is reported that this company and Zhongshan Hospital jointly established the "New Technology Transformation Center for Diagnosis and Treatment", and successfully realized the cooperation mode of "from hospital → transformation platform research and development → enterprise production → laboratory application", and has developed a number of independent knowledge. New technology for the diagnosis and treatment of property rights. The integration of the innovation chain and the industrial chain has been realized.
The layout of this company is relatively comprehensive, there are research and development platforms, as well as three types of medical device qualification production and sales platforms, third-party testing centers, as well as animal experimental institutions and dynamic biological sample libraries.
Jinhua believes that the current medical device field is still based on very innovative conditions, at least much easier than drugs . Innovation, which is inseparable from clinical participation, is funded by enterprises, and is produced by hospitals to jointly create innovative research and development results, so that many enterprises that do not have research and development capabilities also have the opportunity to obtain innovative results.
　　 "A drop of blood" to detect liver cancer
According to related statistics, liver cancer is one of the most common malignant tumor, China's annual newly diagnosed with liver cancer accounted for 55% of the world, ranked second in the mortality rate of all malignant tumors. The 5-year survival rate of advanced liver cancer is close to 0. After radical surgery for early liver cancer, the 5-year survival rate can reach more than 60%.
It can be very cruel: the onset of liver cancer is insidious, and there are no specific symptoms in the early stage. About 80% of the patients have entered the advanced stage and lost the chance of radical surgery. Even if radical surgery is performed, 60% to 70% of the patients will appear within 5 years. Metastasis recurrence; the overall 5-year survival rate of liver cancer patients is only about 7%.
The team led by Prof. Fan Jia, the president of Zhongshan Hospital, has developed the “7 kinds of micro-ribonucleic acid liver cancer detection kits†to diagnose liver cancer after 9 years of development. The sensitivity and specificity are more than 80%. It is reported that the kit has completed multi-center clinical trials. In August last year, it obtained the CFDA three-class device registration certificate and production license.