title: Diagnosis of uncertain primary tumors with the Pathwork tissue-of-origin test.
abstract: 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.
authors.affiliation: Department of Pathology, The Methodist Hospital and The Methodist Hospital Research Institute, 6565 Fannin St, MS-205, Houston, TX 77030, USA. famonzon@tmhs.org
authors.forename: Federico A
authors.initials: FA
authors.lastname: Monzon
authors.forename: Catherine I
authors.initials: CI
authors.lastname: Dumur
mesh_terms: D000818:Animals; D020869:Gene Expression Profiling; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000175:diagnosis / Q000235:genetics / Q000378:metabolism; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods*; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration