Two IVD, confirmed by the State Health Planning Commission

Pharmaceutical Network February 6 News February 5, the State Health Planning Commission released the latest achievements in national science and technology major projects in the field of health, the two IVD products are recognized as a major innovation, a major breakthrough.

The latest results of the major special projects released by the State Health and Welfare Committee involve a number of special projects for the development of new drugs and special infectious diseases. The latest achievements in infectious diseases are the results of two IVD research and development projects.

Both IVD test kit, are affiliated Zhongshan Hospital, Fudan University to undertake research and development work. Wei Planning Commission message said:

Zhongshan Hospital Affiliated to Fudan University made a major breakthrough in the early diagnosis and early diagnosis of liver cancer and the prediction of recurrence and metastasis. Two of the world's first technologies with completely independent intellectual property rights have been listed or contracted respectively.

Its research and development of '7 kinds of microRNA detection system of liver cancer' only need to collect 0.2ml of plasma to accurately diagnose liver cancer, and to fill the clinical clinical monitoring of alpha-fetoprotein-negative liver cancer is still blank, the sensitivity and specificity Up to 80%.

Another 'fully automated cycle of tumor cell sorting and detection system' to the world's first detected 'peripheral blood stem cell-like circulating hepatocellular carcinoma' based on the successful development of the world's first prototype and testing kits, and with the business Cooperation to achieve the transformation.

In fact, this is a medical device company to jointly promote an innovative research and development.This is a Shanghai-based medical device enterprise.

It is reported that this company with Zhongshan hospital Has jointly set up a new center for the diagnosis and treatment of new technologies and has successfully implemented the collaboration model of "R & D from hospital → transformation platform → enterprise production → laboratory application" and has developed a number of new technologies for diagnosis and treatment with independent intellectual property rights Innovation chain and the integration of the industrial chain.

The layout of this enterprise is more comprehensive, both R & D platform, there are three types of medical device qualification of the production and marketing platform, third-party testing center, as well as animal experimental institutions and dynamic biological sample base.

Golden Flower believes that the current field of medical equipment, or very innovative basis for the conditions, at least than drug It is much easier to innovate.It can not be separated from the clinical participation, funded by the enterprise, leaving the hospital to work together to create a model of innovative research and development results, so that many enterprises without research and development capabilities also have the opportunity to obtain innovative achievements.

According to related information, liver cancer is the most common malignancy in the world Tumor One of the new diagnosis of liver cancer in our country each year accounted for 55% of the world, the mortality rate ranked second in all malignant tumors .5-year survival rate of advanced liver cancer close to 0, early liver cancer after radical surgery, 5-year survival rate More than 60%.

Reality is very cruel: the occult onset of liver cancer, early non-specific symptoms, about 80% of patients first diagnosis has entered the late, lost the chance of radical surgery; even the implementation of radical surgery, 5 years, 60% to 70% of patients Metastasis recurrence; 5-year overall survival rate of liver cancer patients is only about 7%.

The team led by Dr. Fan Jia, Dean of Zhongshan Hospital, has developed and developed seven kinds of small RNase detection kit for hepatitis B virus for more than 80% in diagnosis of liver cancer in nine years. It is reported that the kit has been completed Multi-center clinical trial, last August, received CFDA three types of equipment registration certificate and production license.