Department of Pathology, The Methodist Hospital and The Methodist Hospital Research Institute, 6565 Fannin St, MS-205, Houston, TX 77030, USA.
Expert Rev Mol Diagn. 2010 Jan;10(1):17-25. doi: 10.1586/erm.09.75.
Clinical workup of metastatic malignancies of unknown origin is an arduous and expensive process, which is reported to be unsuccessful in up to 30% of cases. Global gene expression-based molecular testing may offer accurate classification of metastatic tumors in which a primary site has not been identified. Recently, the US FDA cleared the Pathwork((R)) tissue-of-origin test, which is a gene expression microarray-based test that quantifies the molecular similarity of tumor specimens to 15 known tissue types. A blinded, multicenter validation on poorly differentiated and undifferentiated tumors showed 87.8% sensitivity and 99.4% specificity in frozen tissue samples. The availability of ancillary gene expression-based molecular tests for tissue of origin determination represents a milestone in cancer patient management as part of the personalized medicine revolution.
不明来源转移性恶性肿瘤的临床评估是一项艰巨且昂贵的过程，据报道，多达 30%的病例评估结果不成功。基于全球基因表达的分子检测可为未确定原发部位的转移性肿瘤提供准确的分类。最近，美国食品药品监督管理局批准了 Pathwork((R))组织起源检测，这是一种基于基因表达微阵列的检测方法，可定量评估肿瘤标本与 15 种已知组织类型的分子相似性。在冷冻组织样本中，一项针对低分化和未分化肿瘤的盲法、多中心验证研究显示，该检测的敏感性为 87.8%，特异性为 99.4%。辅助基于基因表达的分子检测用于确定组织来源，这代表着癌症患者管理作为个性化医疗革命的一部分的一个里程碑。
