Meta-Analysis/Systematic Reviews and Guidelines

Accuracy that Improves Upon Current Staging

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.

Class 1A patients had

5-year RFS of 91.4% and
DMFS of 94.1%

Class 2B patients had

5-year RFS of 43.6% and
DMFS of 55.5%

Patients identified as having Class 2B tumors were

2.9 Times More Likely to Experience a Recurrence and 2.8 Times More Likely to Experience a Distant Metastasis

DecisionDx-Melanoma demonstrated

Superior Sensitivity and Negative Predictive Value (NPV) Compared to SLNB

DecisionDx-Melanoma achieved an

Evidence Rank of
Level 1A

under the Strength of Recommendation Taxonomy (SORT) system, which is also used by the AAD Guidelines Working Group.

Second Meta-Analysis Shows DecisionDx-Melanoma to be an Independent Predictor of Risk

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.

DecisionDx-Melanoma was found to be a consistent, independent and

Significant Predictor of Survival

Significant association between Class 2 test results and

Recurrence-Free, Distant-Metastasis Free and Overall Survival Rates

(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)

DecisionDx-Melanoma test

Results Were Associated With Sentinel Lymph Node Biopsy Status

(odds ratio 2.99; p<0.00001)

Clinical Guidelines

Expert Panel Guidance and Clinical Workflow Incorporates DecisionDx-Melanoma Testing

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.

The goal must be educating the patient on the risks and benefits of treatment options so that the patient can make informed decisions.


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