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New Data Bolster Use of DecisionDx-Melanoma in Clinical Decision-Making

Patients classified as low-risk by the DecisionDx-Melanoma gene expression test showed a sentinel lymph node positivity rate below 5%, according to new data presented at the European Academy of Dermatology and Venereology Congress in Vienna, offering a potential path for some patients to safely avoid invasive surgical staging.

New Data Bolster Use of DecisionDx-Melanoma in Clinical Decision-Making
Photo: Bio & News

The findings, drawn from a prospective, multi-center study of 2,799 patients across 29 U.S. centers, suggest that molecular tumor profiling provides prognostic clarity that traditional staging alone may miss. Among 565 eligible patients who opted against sentinel lymph node biopsy based on low-risk test results, the five-year recurrence-free survival rate reached 99.6%. Conversely, those identified as high-risk showed a 22.8% positivity rate, reinforcing the test’s utility in triage.

Beyond surgical planning, the study highlights the test’s role in managing early-stage melanomas, particularly those with transected samples that often complicate standard risk assessments. Researchers observed that early-stage patients with high-risk molecular profiles exhibited recurrence patterns comparable to stage IIB disease. This suggests that incorporating gene expression data could allow clinicians to justify more intensive surveillance and imaging for patients whose underlying biology indicates a higher risk than their clinical stage might suggest.

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