Abstract
Background: The 31-gene expression profile (31-GEP) test uses 31 genetic markers obtained from the initial biopsy of a melanoma to assess melanoma-specific survival and sentinel lymph node positivity. Objective: To assess the professional understanding, opinions, and clinical usage of the 31-GEP test by dermatologists. Methods: Data from 589 unique dermatologists were collected during 2 virtual, nation-wide dermatology conferences via an 18-question survey on practice demographics and their clinical use and opinion of the 31-GEP test. Results: Participants reported that integrating the 31-GEP test may benefit patients by increasing knowledge and understanding (72.5%), personalizing treatment options (58.8%), and easing uncertainty about the future (59.7%). Benefits of using the 31-GEP test included identifying true negative patients in high-risk populations (65.6%) as well as true positives in low-risk populations (70.6%).A majority of participants also noted that if a patient received a 31-GEP Class 2B result, they would escalate subsequent management even if the lesions were classified as T1 (61.4%) or AJCC8 Stage I (59.0%). 84.9% of participants were somewhat to very likely to use 31-GEP testing for patient management or recommend this test to a colleague. Limitations: Potential respondent-selection and recall bias. Conclusion: Dermatologists are increasingly integrating the 31-GEP test into their melanoma clinical management decisions. As the 31-GEP test becomes more prevalent in practice, patients may benefit from decreased anxiety and uncertainty from enhanced prognosis, decreased need for unwarranted procedures such as sentinel lymph node biopsy and optimized allocation of healthcare resources.
Highlights
The 31-gene expression profile test (31GEP) (DecisionDx-Melanoma, Castle Biosciences, Inc., Friendswood, TX) analyses tissue collected from the initial diagnostic biopsy of a melanoma with an array of 31 genetic markers to assess prognosis
As the 31-gene expression profile (31-GEP) test becomes more prevalent in practice, patients may benefit from decreased anxiety and uncertainty from enhanced prognosis, decreased need for unwarranted procedures such as sentinel lymph node biopsy and optimized allocation of healthcare resources
Over 65% of the participants were private practice dermatologists with 48.2% having at least 11 years of independent clinical practice (Table 1). 52.5% of participants diagnosed at least 20 new melanomas in 2019 with 42.6% ordering between 1 and 20 31-GEP tests within the past 12 months
Summary
The 31-gene expression profile test (31GEP) (DecisionDx-Melanoma, Castle Biosciences, Inc., Friendswood, TX) analyses tissue collected from the initial diagnostic biopsy of a melanoma with an array of 31 genetic markers to assess prognosis. Prior studies have validated its ability to determine the risk of local/distant recurrence and sentinel lymph node positivity to assist in clinical decisionmaking.[1,2,3] The 31-GEP test is reimbursable under Medicare, certified by the Clinical Laboratory Improvement Amendments (CLIA), and was ordered over 16,000 times during 2019.1,4 Given the increasingly widespread use of 31-GEP, the purpose of this study was to assess the professional understanding, opinions, and clinical usage of the 31-GEP test by dermatologists. The 31-gene expression profile (31-GEP) test uses 31 genetic markers obtained from the initial biopsy of a melanoma to assess melanoma-specific survival and sentinel lymph node positivity
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