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]
透景生命:子公司申报医疗器械注册获得受理