Two IVD Models, confirmed by NHFPC (National Health and Family Planning Commission)

  • 2018-02-12
On February 5, the NHFPC published the latest achievements of National Science and Technology Major Projects in the health & medicine field, where two IVD models were approved as radical innovation and major breakthrough.

The two IVD models designed to detect kits are developed by the Zhongshan Hospital affiliated to Fudan University. According the to the NHFPC news, the Zhongshan Hospital has made major breakthrough in the early diagnosis and treatment of liver cancer and prediction techniques of recurrence and metastasis, where two techniques first developed in the world with complete intellectual property rights have become commercially available or entered an agreement for achievement transformation. The 7-miRNA Liver Cancer Assay Kit developed by the Zhongshan Hospital can accurately diagnose liver cancer with only 0.2ml plasma. With sensitivity and specificity up to 80% or more, this technique fills the gap of no clinically effective approach available for AFP negative hepatoma. For the other Automatic Circulating Tumor Cell Sorting and Detection System, based on the stem cell-like circulating hepatoma cells in the peripheral blood first detected in the globe, its first prototype and assay kit in the world were successfully developed and its achievement transformation was realized through cooperation with enterprises.

According to relevant information, liver cancer is the most common malignant tumor in the world. The newly diagnosed hepatocellular carcinoma every year accounts for 55% of the world and its mortality ranks the second place among all the malignant tumors. The five-year survival rate of advanced liver cancer is close to 0 while the five-year survival rate of early liver cancer post radical resection can reach up to 60% or more.

The team led by Prof. Fan Jia, the president of Zhongshan Hospital took 9 years to develop the 7-miRNA Liver Cancer Assay Kit for the diagnosis of liver cancer, where the sensitivity and specificity can reach up to 80% or more. As is reported, now the assay kit has completed its multi-center clinical trial and obtained class III medical device registration certificate and production license issued by the CFDA in the last August.