DecisionDx-UM Prospective Clinical Validation Studies

DecisionDx^®-UM
Prospective Clinical Validation Studies

GEP Test: Validated by Multiple Prospective Studies

The DecisionDx-UM gene expression profile (GEP) test is a robust multianalyte assay that accurately predicts 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 completed validation and is no longer considered experimental or investigational. Seven 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

Study	Design	n	3-year MFS or DSS			5-year MFS or DSS
Study	Design	n	Class 1A	Class 1B	Class 2	Class 1A	Class 1B	Class 2
Onken et al., 2012	Prospective multi- center	446	98%	93%	50%	98%	79%	28%
Chappell et al., 2012	Retrospective single- center	187				93%		38%
Correa & Augsburger, 2014	Prospective single- center	159				92%		55%
Correa & Augsburger, 2016	Prospective single- center	299	95%		69%	92%		55%
Plasseraud et al., 2016	Prospective multi- center	70	100%		63%	Reported in Aaberg et al., 2020
Demirci et al., 2018	Retrospective single- center	293	99%	90%	60%	Accrual ongoing
Aaberg et al., 2020	Prospective, multi- center	89				94%		63%
Binkley et al., 2020	Retrospective, 2-center	215	96%		63%	96%		49%

MFS, Metastasis Free Survival; DSS, Disease Specific Survival

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.