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000156842 1001_ $$00000-0001-7760-410X$$aTalhouk, Aline$$b0
000156842 245__ $$aDevelopment and validation of the gene-expression Predictor of high-grade-serous Ovarian carcinoma molecular subTYPE (PrOTYPE).
000156842 260__ $$aPhiladelphia, Pa. [u.a.]$$bAACR$$c2020
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000156842 500__ $$a2020 Oct 15;26(20):5411-5423
000156842 520__ $$aGene-expression-based molecular subtypes of high-grade serous tubo-ovarian cancer (HGSOC), demonstrated across multiple studies, may provide improved stratification for molecularly targeted trials. However, evaluation of clinical utility has been hindered by non-standardized methods which are not applicable in a clinical setting. We sought to generate a clinical-grade minimal gene-set assay for classification of individual tumor specimens into HGSOC subtypes and confirm previously reported subtype-associated features.Adopting two independent approaches, we derived and internally validated algorithms for subtype prediction using published gene-expression data from 1650 tumors. We applied resulting models to NanoString data on 3829 HGSOCs from the Ovarian Tumor Tissue Analysis Consortium. We further developed, confirmed, and validated a reduced, minimal gene-set predictor, with methods suitable for a single patient setting.Gene-expression data was used to derive the Predictor of high-grade-serous Ovarian carcinoma molecular subTYPE (PrOTYPE) assay. We established a de facto standard as a consensus of two parallel approaches. PrOTYPE subtypes are significantly associated with age, stage, residual disease, tumor infiltrating lymphocytes, and outcome. The locked-down clinical-grade PrOTYPE test includes a model with 55 genes that predicted gene-expression subtype with >95% accuracy that was maintained in all analytical and biological validations.We validated the PrOTYPE assay following the Institute of Medicine guidelines for the development of omics-based tests. This fully defined and locked-down clinical-grade assay will enable trial design with molecular subtype stratification and allow for objective assessment of the predictive value of HGSOC molecular subtypes in precision medicine applications.
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000156842 7001_ $$00000-0003-2638-3081$$aWang, Chen$$b2
000156842 7001_ $$aBudden, Timothy$$b3
000156842 7001_ $$00000-0001-6624-1593$$aTan, Tuan Zea$$b4
000156842 7001_ $$aChiu, Derek S$$b5
000156842 7001_ $$aKommoss, Stefan$$b6
000156842 7001_ $$aLeong, Huei San$$b7
000156842 7001_ $$aChen, Stephanie$$b8
000156842 7001_ $$aIntermaggio, Maria P$$b9
000156842 7001_ $$aGilks, Blake$$b10
000156842 7001_ $$aNazeran, Tayyebeh Mehrane$$b11
000156842 7001_ $$aVolchek, Mila$$b12
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000156842 7001_ $$aBentley, Rex C$$b14
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000156842 7001_ $$aLum, Amy$$b16
000156842 7001_ $$aChow, Veronica$$b17
000156842 7001_ $$aSudderuddin, Hanwei$$b18
000156842 7001_ $$aMackenzie, Robertson$$b19
000156842 7001_ $$aLeung, Samuel$$b20
000156842 7001_ $$aLiu, Geyi$$b21
000156842 7001_ $$aJohnson, Dustin$$b22
000156842 7001_ $$aChen, Billy$$b23
000156842 7001_ $$aOvarian Cancer Study, Australian$$b24
000156842 7001_ $$aAlsop, Jennifer$$b25
000156842 7001_ $$aBanerjee, Susana$$b26
000156842 7001_ $$0P:(DE-He78)6b04712f3afe72044d496a25505cb1ea$$aBehrens, Sabine$$b27$$udkfz
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000156842 7001_ $$00000-0002-4465-5784$$aKennedy, Catherine J$$b52
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000156842 7001_ $$aRay-Coquard, Isabelle$$b73
000156842 7001_ $$aRhenius, Valerie$$b74
000156842 7001_ $$00000-0001-8750-7338$$aRodríguez-Antona, Cristina$$b75
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000156842 7001_ $$aSherman, Mark E$$b77
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000156842 7001_ $$00000-0003-2836-6699$$aSinn, Hans-Peter$$b80
000156842 7001_ $$aSlamon, Dennis J$$b81
000156842 7001_ $$aSong, Honglin$$b82
000156842 7001_ $$aSteed, Helen$$b83
000156842 7001_ $$aStronach, Euan A$$b84
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000156842 7001_ $$00000-0002-1539-6090$$aTrabert, Britton$$b87
000156842 7001_ $$aTraficante, Nadia$$b88
000156842 7001_ $$aTseng, Chiu-Chen$$b89
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