PML/RARA融合基因检测试剂盒(荧光原位杂交法)
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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
(文章来源:证券日报) 证券日报网讯 11月13日晚间,透景生命发布公告称,公司控股子公司武汉康录生物技术股份有限公司 申报的境内体外诊断试剂注册申请于近日获得了国家药品监督管理局的受理,产品名称:PML/RARA 融合基因检测试剂盒(荧光原位杂交法)。 ...
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]