Expert Panel Unanimously Backs DecisionDx-Melanoma for Guiding Personalized Cancer Care

A new expert consensus panel review published in the Dermatology Online Journal provides a robust endorsement for integrating Castle Biosciences’ DecisionDx-Melanoma 31-gene expression profiling (31-GEP) test into the management of patients with invasive cutaneous melanoma.¹ The review, conducted by 10 board-certified dermatologists specializing in melanoma management, aimed to clarify the clinical efficacy, use, and accuracy of the 31-GEP test to guide real-world decision-making.

Methodology and Consensus Statements

The comprehensive literature search identified 26 eligible articles encompassing more than 7,500 patients, which were subsequently reviewed by the panel. Utilizing a modified Delphi process and the Strength of Recommendation Taxonomy (SORT) criteria for grading evidence, the panel unanimously adopted 9 consensus statements regarding 31-GEP testing, 8 of which were assigned a strength of recommendation "A."

“Consensus efforts like this are important to help clinicians interpret and apply emerging data in a consistent, evidence-based way,” said Rebecca Critchley-Thorne, PhD, vice president of research and development at Castle Biosciences. “This study in particular can give physicians confidence on when and where DecisionDx-Melanoma fits within current management strategies to support more individualized care for patients with cutaneous melanoma.”²

Addressing the Limitations of Traditional Staging

Traditional prognostication for melanoma relies heavily on the American Joint Committee on Cancer 8th edition (AJCC8) staging system. However, this system has limitations as it does not provide individualized risk profiles, leading to heterogeneous survival rates within the same stage. The 31-GEP test was developed to address this by evaluating the expression of specific gene targets, classifying patients as low risk (Class 1A), intermediate risk (Class 1B/2A), or high risk (Class 2B) for recurrence, metastasis, and melanoma-specific survival (MSS).

Key Findings and Prognostic Value

The expert panel concluded there is strong evidence that the 31-GEP test is an independent predictor of regional or distant metastatic recurrence and death. Furthermore, integrating 31-GEP test results with traditional staging methods significantly enhances the assessment of a patient's prognosis. One key consensus statement affirms that the 31-GEP test improves prognosis assessment when added to the AJCC8 staging system (Strength A, 10/10 vote).

The panel highlighted several studies demonstrating the clinical utility of the 31-GEP test in clinical decision-making, including informing sentinel lymph node biopsy (SLNB) decisions. Studies have shown improved cutaneous melanoma survival stratification through the integration of 31-GEP testing with AJCC8 staging. The integrated 31-GEP (i31-GEP) result further combines the gene test with clinicopathologic (CP) features using an AI-based algorithm to provide a personalized risk assessment for SLNB positivity in T1-T4 invasive melanoma patients.

Clinical Utility in Decision-Making

Another notable strength of the 31-GEP test is its utility when traditional clinicopathologic factors are unknown or ambiguous—a common issue in biopsies from cosmetically sensitive or anatomically restrictive areas. The experts approved a consensus statement that studies demonstrate clinical efficacy for the 31-GEP test in providing prognostic information for invasive melanoma across all tumor stages, even when the thickness or other traditional factors are unknown (SORT Level A, 10/10 approved). For example, the i31-GEP test has been shown to reclassify a substantial portion of high-risk T1a and T1b tumors, expanding the proportion of patients identified as having a low probability of SLNB positivity. Overall, the expert panel concluded that the DecisionDx-Melanoma test “should be recognized as a best-practice approach for the management of patients with melanoma, guiding evidence-based, patient-centered care.”

“This consensus translates the robust data supporting DecisionDx-Melanoma into practical direction for clinicians,” said Derek Maetzold, president and chief executive officer of the company. “The panel’s unanimous endorsement of DecisionDx-Melanoma underscores its value in supporting informed, personalized care decisions that may help improve outcomes for patients with melanoma.”²

References

1. Burshtein J, Cockerell C, Cotter D, et al. 31-gene expression profiling for cutaneous melanoma: An expert consensus panel. Dermatology Online Journal. 2025;31(5). doi:10.25251/c81v6j23

2. Expert Melanoma Panel Recommends Castle Biosciences’ DecisionDx®-Melanoma as a Best-Practice Tool for Managing Patients with Melanoma. News release. Globe Newswire. Published December 9, 2025. Accessed December 16, 2025. https://www.globenewswire.com/news-release/2025/12/09/3202211/0/en/Expert-Melanoma-Panel-Recommends-Castle-Biosciences-DecisionDx-Melanoma-as-a-Best-Practice-Tool-for-Managing-Patients-with-Melanoma.html