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CFDA Approved In-Vitro Diagnostic (IVD) Reagents For Liver Cancer Detection


CFDA has just approved a prothrombin (DCP, PIVKA-II) and alpha-fetoprotein heterogeneity (AFP-L3) ratio of automatic chemiluminescence detection reagents, with China’s first fully independent owned intellectual property rights. This means that as a large country of liver cancer, China has, for the first time, a serum marker of liver cancer that has reached the international standard.

It is understood that primary liver cancer is currently the fourth most common malignant tumor in China and the third leading cause of cancer death. How early detection of liver cancer has always been an important challenge for the medical community. Currently, the industry has listed DCP (PIVKA-II) and AFP-L3 as an extremely important indicator for detection of liver cancer and is recommended for screening at high risk, diagnosis of liver cancer and monitoring the therapeutic effect and as a prediction tool for prognosis and recurrence . For a long time, the detection technology is monopolized by a few foreign companies.

People’s Liberation Army 302 Hospital, Beijing thermal View Biological Technology Co., Ltd. and other units lasted many years, not only the successful development of a specific monoclonal antibody against abnormal prothrombin, also developed the first independent intellectual property rights of abnormal prothrombin automatic chemical Luminescent detection reagent, AFP-L3 has also achieved full automatic detection.

The successful development of abnormal prothrombin reagents will completely change the current monopoly status of such imported products and allow China to have a series of tools for early diagnosis and detection of liver cancer with its own production and at a lower cost so as to improve the early diagnosis rate of liver cancer, Medical treatment and health management provide sharp weapons. Its clinical application will significantly improve the early diagnosis of liver cancer in China, reduce medical costs and improve the quality of life of patients.

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