The consensus report endorses Castle’s DecisionDx-Melanoma GEP risk stratification test.

The National Society for Cutaneous Medicine now recommends use of gene expression profile (GEP) testing in the clinical assessment and management of cutaneous melanoma (CM). 

The report provides usage guidelines and a framework for clinicians to integrate GEP testing into their CM patient management. Additionally, the consensus report endorses Castle’s DecisionDx-Melanoma GEP risk stratification test as offering more utility than other existing CM GEP assays or nomograms, supported by extensive, evidence-driven data in current literature.

“DecisionDx-Melanoma test results provide valuable information beyond current staging guidelines to help clinicians and patients make more informed, risk-aligned management decisions,” saus Matthew Goldberg, M.D., F.A.A.D., board-certified dermatologist and dermatopathologist, and medical director of Castle Biosciences, in a news release. “We are pleased that the consensus report supported the overall value and use of our test to help improve CM patient management.”

The report was compiled by a panel of six key opinion leaders in dermatology with specialized expertise in managing CM. The panel reviewed 32 studies published between 2019 through 2022 assessing the use of GEP testing in CM prognosis. Twenty-two of the studies reviewed assessed the utility of DecisionDx-Melanoma, Castle’s 31-GEP risk stratification test designed to inform two clinical questions in the management of CM: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient's personal risk of melanoma recurrence and/or metastasis. Based on a review of the studies, the panel developed six usage guidelines and five consensus supporting statements providing a framework for clinicians to integrate GEP testing into their CM patient management. Each of the recommendations was given a strength “A,” “B,” or “C” according to Strength of Recommendation Taxonomy (SORT) criteria. 

The panel report is published in SKIN: Journal of Cutaneous Medicine.

Four of the 11 key usage guidelines and consensus supporting statements were given a strength of “A,” the strongest recommendation by the panel. They include the following:

Usage guidelines:

• “Integrating GEP results can improve prognostic assessment for patients with T1a tumors at least 0.3mm in depth, T1b+ tumors or any tumor in which there is significant uncertainty about adequacy of microstaging (e.g., positive deep margin)” (SORT Level=A)
• “GEP testing can identify a high-risk subset for recurrence, distant metastasis or death of traditionally assessed low-risk patients (e.g., SLN negative or T1a/b)” (SORT Level=A)
• “GEP testing provides clinically useful information that augments risk-aligned management decisions to both rule-in or rule-out the need for SLNBx and subsequent management plans” (SORT Level=A)

Consensus supporting statement:

• “Current literature supports that the 31-GEP test [i.e., DecisionDx-Melanoma], with its more extensive evidence-driven data, offers more utility than other existing GEP assays or nomograms” (SORT Level=A)