TEST:

DecisionDx®-Melanoma

Two commercial tests are widely available: the 31-gene expression profile (31-GEP, DecisionDx-Melanoma, Castle Biosciences) and the clinicopathologic gene expression profile (CP-GEP, Merlin, SkylineDx). This review summarizes the current evidence for each assay regarding their performance and utility, with a focus on potentially actionable use cases, limitations, and the practical context in which these tools are most valuable.

''Castle Biosciences, Inc...today announced new data from the largest prospective multicenter study to date evaluating DecisionDx-Melanoma’s integrated sentinel lymph node biopsy (i31-SLNB) test result.''

''Castle Biosciences, Inc...today announced the publication of results from the largest prospective, multicenter study to date evaluating DecisionDx-Melanoma’s integrated sentinel lymph node biopsy (i31-SLNB) test result.¹ The paper, available in Future Oncology, confirms that DecisionDx-Melanoma’s i31-SLNB identifies patients below the 5% National Comprehensive Cancer Network® (NCCN) threshold for forgoing sentinel lymph node biopsy (SLNB) and outperforms traditional staging criteria and other predictive gene expression profile (GEP) tests.''

In this multi-center prospective study, the i31-SLNB accurately predicted SLN positivity, and patients who avoided SLNB based on i31-SLNB results had high RFS. Thus, the i31-SLNB identifies low-risk patients who may consider foregoing the SLNB procedure.

The test provides prognostic information when thickness and other traditional factors are unknown, improves prognosis assessment when added to American Joint Committee on Cancer 8th edition staging system, and is associated with improved melanoma-specific mortality and overall survival. The panel concluded that the robust existing literature strongly supports its use as a best practice for appropriate patients with melanoma.

Pragmatic implementation of a risk-stratified surveillance strategy has resulted in few instances of asymptomatic, imaging-detected recurrences among early-stage cutaneous melanoma patients at short-term follow-up benchmarks. Further follow-up is necessary to determine the validity of this approach.

''Castle Biosciences, Inc...today announced new data demonstrating the clinical value of its DecisionDx-Melanoma test in improving sentinel lymph node (SLN) biopsy (SLNB) decision making and enhancing recurrence risk prediction in patients with cutaneous melanoma (CM). ''

"Castle Biosciences...today announced that it is presenting data on its DecisionDx®-Melanoma test and its pipeline atopic dermatitis (AD) gene expression profile (GEP) test at the 25th Annual Fall Clinical Dermatology Conference®, taking place Oct. 23–26, 2025, in Las Vegas, Nevada."

"Castle Biosciences, Inc...today announced that its DecisionDx-Melanoma test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). DecisionDx-Melanoma is a gene expression profile (GEP) test that provides comprehensive, personalized results to guide risk-aligned management decisions for patients diagnosed with stage I-III cutaneous melanoma."