PML/RARA融合基因检测试剂盒(荧光原位杂交法)
Search documents
透景生命:关于子公司申报医疗器械注册获得受理的公告
Zheng Quan Ri Bao· 2025-11-13 14:12
Core Points - The company, Toujing Life, announced that its subsidiary, Wuhan Kanglu Biotechnology Co., Ltd., has received acceptance for its domestic in vitro diagnostic reagent registration application from the National Medical Products Administration [2] Group 1 - The product name is PML/RARA fusion gene detection kit (fluorescence in situ hybridization method) [2]
透景生命(300642.SZ):子公司申报医疗器械注册获得受理
Ge Long Hui A P P· 2025-11-13 12:48
Core Viewpoint - The company announced that its subsidiary, Wuhan Kanglu Biological Technology Co., Ltd., has received acceptance for its application for the registration of an in vitro diagnostic reagent for the PML/RARA fusion gene detection kit, which is significant for the diagnosis of acute promyelocytic leukemia (APL) [1] Group 1 - The PML/RARA fusion gene is a critical molecular mechanism in the development of APL, with over 90% of APL patients exhibiting a specific chromosomal translocation t(15;17)(q24;q12) [1] - The detection of the PML/RARA fusion gene provides a reference for the molecular typing of leukemia, although the results should not be the sole basis for patient diagnosis [1] - The acceptance of this product application enhances the company's molecular diagnostic product line, which is expected to strengthen its leading position in the domestic pathology market and improve market competitiveness [1]
透景生命:子公司申报医疗器械注册获得受理
Ge Long Hui· 2025-11-13 12:32
Core Viewpoint - The company announced that its subsidiary, Wuhan Kanglu Biological Technology Co., Ltd., has received acceptance for its application for the registration of an in vitro diagnostic reagent for the PML/RARA fusion gene detection kit, which is significant for the diagnosis of acute promyelocytic leukemia (APL) [1] Group 1 - The PML/RARA fusion gene is a critical molecular mechanism in the development of APL, with over 90% of APL patients exhibiting a specific chromosomal translocation t(15;17)(q24;q12) [1] - The detection of the PML/RARA fusion gene provides a reference for the molecular typing of leukemia, although the results should not be the sole basis for patient diagnosis [1] - The acceptance of this product application enhances the company's molecular diagnostic product line, contributing to a comprehensive market offering and strengthening its competitive position in the domestic pathology market [1]