透景生命：骨髓增生异常综合征染色体及基因异常检测试剂盒(荧光原位杂交法)医疗器械注册获受理

Core Viewpoint - The announcement indicates that the company's subsidiary, Wuhan Kanglu Biological Technology Co., Ltd., has had its application for a domestic in vitro diagnostic reagent accepted by the National Medical Products Administration, focusing on a kit for detecting chromosomal and genetic abnormalities in myelodysplastic syndromes [2] Group 1: Product Details - The accepted product is a "Chromosomal and Genetic Abnormality Detection Kit for Myelodysplastic Syndromes (Fluorescence In Situ Hybridization Method)" [2] - This kit is primarily used for detecting common chromosomal and genetic abnormalities in myelodysplastic syndromes, with results intended for clinical reference only and not as the sole basis for patient diagnosis [2] Group 2: Clinical Relevance - Myelodysplastic syndromes are heterogeneous myeloid clonal diseases originating from hematopoietic stem cells, characterized by ineffective hematopoiesis and refractory cytopenia, with a high risk of transformation to acute myeloid leukemia [2] - 40%-70% of primary myelodysplastic syndrome patients present chromosomal abnormalities at initial diagnosis, making chromosomal karyotype abnormalities a major criterion in the Vienna diagnostic standards for myelodysplastic syndromes [2] Group 3: Detection Improvement - The use of the myelodysplastic syndrome probe set for fluorescence in situ hybridization can enhance the detection rate of cytogenetic abnormalities in certain patients [2]