DecisionDx-UM Comparison to Other Prognostic Markers

DecisionDx^®-UM
Comparison to Other Prognostic Markers

Multiple Studies Find DecisionDx-UM Superior to TNM Staging, Chromosome 3

The 15-gene expression profile (GEP) test has been compared to clinical, pathologic, and chromosomal factors in multiple prospective and retrospective studies (Worley, 2007; Harbour, 2010; Augsburger, 2010; Onken, 2010, Onken, 2012; Chappell, 2012; Gill, 2012, Correa and Augsburger, 2014, Correa and Augsburger, 2016, Walter, 2016, Plasseraud, 2016, Decatur, 2016 and Aaberg, 2020). In all of these studies, summarized in the table below, the 15-GEP has consistently been shown to be more accurate and superior to all other prognostic factors.

Summary of Studies Comparing DecisionDx-UM to Clinicopathologic and Genetic Features

Study	n	Factors Examined	Comparison to Other Prognostic Features
Onken et al., 2012 (COOG)	446	Age, ciliary body involvement, tumor diameter, tumor thickness, cell type, chromosome 3 status	DecisionDx-UM was the only significant independent predictor of metastasis in multivariate analysis (p=0.006)
Chappell et al., 2012	187	Tumor size, cell type, age	DecisionDx-UM was the only significant predictor of metastasis-free survival and disease-specific survival in multivariate analysis (p<0.0001 for both)
Gill & Char, 2012	meta- analysis	Clinical, cytogenetic, histologic features	Molecular class has the strongest predictive value for metastasis and mortality
Correa & Augsburger, 2014	158	Cytopathology	DecisionDx-UM was superior to cytologic classification for predicting metastasis and death
Correa & Augsburger, 2016	299	Age, gender, ciliary body involvement, largest basal diameter, thickness, cell type	DecisionDx-UM was the strongest prognostic factor for melanoma-specific mortality (p=0.0019) in multivariate analysis
Walter et al., 2016	580 (346 not in COOG)	Age, ciliary body involvement, largest basal diameter, thickness, cell type	DecisionDx-UM was the strongest prognostic factor for PFS and the only significant prognostic factor for OS in multivariate analysis (p<0.001 for both)
Plasseraud et al., 2016	70	Age, largest basal diameter, ciliary body involvement, tumor thickness	DecisionDx-UM was the strongest prognostic factor for metastasis in multivariate and Kaplan-Meier analyses (p=0.016)
Decatur et al., 2016	81	GNAQ, GNA11, BAP1, SF3B1, EIF1AX mutations; age, gender, ciliary body involvement, cell type, extraocular extension, tumor thickness, largest basal diameter	DecisionDx-UM was the strongest predictor of metastasis and melanoma-specific mortality (p<0.001 for both) in multivariate analysis
Aaberg et al., 2020	89	Age, largest basal diameter, ciliary body involvement, tumor thickness	DecisionDx-UM was the strongest prognostic factor for metastasis in multivariate analysis (p<0.0001)