Scientific Evidence

DecisionDx-UM is supported by extensive published evidence

The DecisionDx-UM gene expression profile (GEP) test is a robust multianalyte assay that accurately identifies which patients are at high and low risk of developing metastatic disease within five years. The test, along with specimen collection techniques, has been validated on both fresh-frozen samples obtained from fine-needle aspirate biopsy procedures (FNAB), and on archival tissue derived from formalin-fixed, paraffin-embedded (FFPE) samples.

Clinically, the test has been clinically validated and is no longer considered experimental or investigational. Many validation and performance studies have been conducted to confirm the clinical accuracy of DecisionDx-UM and include multiple independent retrospective and prospective sample sets.

Summary of clinical validity and performance studies with reported outcomes

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)

Study highlight: COOG study finds DecisionDx-UM robust and highly accurate

The first prospective validation study of DecisionDx-UM was a 5-year prospective, multicenter, 494-patient study by the Collaborative Ocular Oncology Group (COOG), published in Ophthalmology (Onken et al, 2012). This study compared DecisionDx-UM to all clinical and pathologic prognostic factors and found it to be superior to, and independent of, all such factors (eg, tumor diameter, tumor thickness, patient age, histopathology involvement, cytopathology and chromosome 3 status).

 

Consistent with prior retrospective and prospective single-center studies, the COOG study found the DecisionDx-UM test to be accurate in differentiating between low-risk (Class 1) tumors and high-risk (Class 2) tumors (log-rank test, p<10e-4). The Kaplan Meier plot below shows the percent of Class 1 and Class 2 patients who remained metastasis-free over 50 months of follow-up. Additional data from this study, including multivariate analyses, can be found in comparison to other prognostic markers.

Kaplan meier curve of metastasis-free survival (MSS) over five months for patients with a low biological risk and patients with a high biological risk score. At three months, nearly 100% of low risk patients and 60% of high risk patients survived with no metastasis.

Meets highest levels of validation

DecisionDx-UM is the only prognostic test for uveal melanoma that has been clinically validated by an independent prospective, multi-center study, as well as multiple retrospective and prospective single-center studies. Twenty-five peer-reviewed scientific publications, including analytical validation, clinical validation, clinical utility and patient perspective studies, support the clinical use of DecisionDx-UM.

Analytical validity

  • CLIA Lab Analytical Validity Study
  • CAP Accreditation
  • NYS DoH Approval
  • State Licenses - CA, FL, MD, NY, PA, RI
  • Onken et al. J Mol Diagn. 2010
  • Plasseraud et al. Diagn Pathol. 2017
  • Klofas et al. Am J Ophthalmol. 2020

Clinical validity

  • Onken et al. Ophthalmology 2012
  • Gill and Char. Can J Ophthalmol. 2012
  • Chappell et al. Am J Ophthalmol. 2012
  • Correa et al. Graef Arch Clin Exp Ophthalmol. 2014
  • Correa et al. Am J Ophthalmol. 2016
  • Decatur et al. JAMA Ophthalmol. 2016
  • Walter et al. JAMA Ophthalmol. 2016
  • Plasseraud et al. J Oncol. 2016
  • Demirci et al. Am J Ophthalmol. 2018
  • Cai et al. Am J Ophthalmol. 2018
  • Afshar et al. Transl Vis Sci Technol. 2019
  • Aaberg et al. Ocul Oncol Pathol. 2020
  • Binkley et al. Ophthalmol Retina. 2020

Clinical validity

  • Aaberg et al. Clin Ophthalmol. 2014
  • Plasseraud et al. J Oncol. 2016
  • Davanzo et al. Br J Ophthalmol. 2019
  • Schefler et al. Melanoma Manag. 2020
  • Aaberg et al. Ocul Oncol Pathol. 2020
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