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• W2602314384 abstract "10576 Background: The differential diagnosis between primary epithelial ovarian and endometrial cancers is often unresolved because the histologic subtypes of these two tumor types can have very similar histology and immunohistochemical appearance. Here we report the development and validation of a gene expression profile (GEP) diagnostic test (Pathwork Tissue of Origin Endometrial Test) that distinguishes ovarian and endometrial cancers in formalin-fixed, paraffin-embedded (FFPE) specimens using a 316–gene classification model. Methods: The test was clinically validated in a blinded study using a pre-specified algorithm and microarray data files for 75 metastatic, poorly differentiated or undifferentiated primary FFPE tumor specimens that had either a known clinical diagnosis of ovarian or endometrial cancer and belonged to one of the 14 ovarian and endometrial WHO histologic subtypes on the test panel. Results: Classification biomarkers, empirically selected by machine learning, included several genes such as homeobox transcription factors and kallikrein peptidases with known function in the biology of ovarian and endometrial cancers. The Tissue of Origin Endometrial Test accurately identified the primary site for 94.7% (95% CI, 87% to 99%) of ovarian and endometrial cancers. Other measures of test performance include an area under the ROC curve of 0.997 and a diagnostic odds ratio of 406. Test performance did not change significantly when stratified by specimens from metastases (90.5%) or by poorly differentiated and undifferentiated primary tumors (96.3%). All stages of ovarian and endometrial cancers were included in the validation study and had agreements of 85% to 100% with the clinical diagnosis. In a precision study, concordance in test results was 100%. Reproducibility in test results between three laboratories had a concordance of 94.3%. Conclusions: The GEP test identified specific ovarian and endometrial cancer morphologies even when a clear distinction could not be made by histologic criteria. The GEP test can aid in resolving an important differential diagnostic question in gynecologic oncology and may impact clinical management of these patients as well as entry opportunities into clinical trials." @default.
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• W2602314384 date "2012-05-20" @default.
• W2602314384 modified "2023-09-25" @default.
• W2602314384 title "A gene expression profile test that distinguishes ovarian from endometrial cancers." @default.
• W2602314384 doi "https://doi.org/10.1200/jco.2012.30.15_suppl.10576" @default.
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