Two systematic reviews with meta-analyses have demonstrated that DecisionDx®-Melanoma is an independent predictor of outcomes with an accuracy that improves upon current staging. The studies were performed in accordance with the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) statement.
The first (Greenhaw et al. 2020) was performed on the largest DecisionDx-Melanoma cohort to date (n=1,479) with results that confirm the test can further stratify AJCC-staged patients. This further stratification can result in increased or decreased individual risk of recurrence or distant metastasis, augmenting AJCC staging alone.
The analysis demonstrated a consistent, independent prognostic value of DecisionDx-Melanoma across the 4 included studies.
Patients identified as having Class 2B tumors were
under the Strength of Recommendation Taxonomy (SORT) system, which is also used by the AAD Guidelines Working Group.
A second, independent systematic review and meta-analysis demonstrated that DecisionDx®-Melanoma is a significant predictor of recurrence and metastatic risk in patients with melanoma (Litchman et al. 2020) The systematic review identified several gene expression profile assays described in the literature, but only DecisionDx-Melanoma was supported by consistent reporting of results and quantity of evidence sufficient for inclusion in the meta-analysis performed by study co-authors.
(recurrence-free HR=7.22; p<0.00001, distant-metastasis free HR=6.62; p<0.00001, and overall survival HR=7.06; p<0.00001)
(odds ratio 2.99; p<0.00001)
A panel of melanoma experts established guidance for use of the DecisionDx-Melanoma test within AJCC staging and integrated into NCCN guidelines based on their experience using the DecisionDx-Melanoma test (Kwatra et al. 2020). The group concluded that the test demonstrates a robust and consistent body of evidence that supports clinical utility and provides value in conjunction with SLNB for the prognosis of patients with melanoma. The test can inform multidisciplinary conference discussion and can assist with determining the intensity of imaging, surveillance, and follow-up care. In a workflow developed to improve risk-stratification and inform decision-making, the rationale for testing varies across stage groups and SLN status.
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