上述受理产品主要应用于骨髓增生异常综合征中常见染色体及基因异常的检测，其检测结果仅供临床参 考，不应作为患者诊断的唯一依据，临床医生应结合临床其他检测指标等因素对检测结果进行综合判 断。骨髓增生异常综合征是一组起源于造血干细胞的异质性髓系克隆性疾病，其特点是髓系细胞发育异 常，表现为无效造血、难治性血细胞减少，高风险向急性髓系白血病转化。40%-70%的原发性骨髓增生 异常综合征患者在初诊时便存在染色体异常。染色体核型异常是骨髓增生异常综合征维也纳诊断标准中 主要标准之一。应用骨髓增生异常综合征组套探针进行荧光原位杂交检测，可提高部分患者细胞遗传学 异常检出率。 智通财经APP讯，透景生命(300642.SZ)发布公告，公司控股子公司武汉康录生物技术股份有限公司(以 下简称"康录生物"或"控股子公司")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，涉及产品："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)"。 ...

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]