Cancer Treatment Today

DecisionDx is a molecular diagnostic test developed at and licensed from The University of Texas M. D. Anderson Cancer Center. The test is used to prospectively predict patient outcome to treatment for various cancers. There is an urgent need to be able to subclassify patients with early stage melanoma according to risk 1.
A study presented at the annual meeting of the American Society for Clinical Oncology has demonstrated that DecisionDx-Melanoma (Castle Biosciences), a commercially available gene expression-profile (GEP) test, can be a useful prognostic tool for patients with high-risk cutaneous melanoma who undergo sentinel lymph node (SLN) biopsy. It is not a prospective study, and does not demonstrate that using this test leads to better decision making,  which is what would be necessary to establish benefit of a prognostic test.

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors. In A RECENT INDEPENDENT study by Dubin, et al. titled, “Level of Evidence Review for a Gene Expression Profile Test for Cutaneous Melanoma,” the researchers conducted a review of seven development and validation studies for the DecisionDx-Melanoma test. They then applied attributes of each study to the level of evidence criteria for the American Joint Committee on Cancer (AJCC), National Comprehensive Cancer Network (NCCN) and American Academy of Dermatology (AAD). The AJCC, NCCN, and AAD are considered major authoritative organizations that many dermatologists rely upon to provide skin cancer guidelines, and each employs a unique ranking system to assign a level of evidence to the management of melanoma. The evaluation of seven development and validation studies led the authors to classify DecisionDx-Melanoma as level I/II, IIIIB and IIA according to AJCC, NCCN and AAD criteria, respectively, which are higher than the official unrated status conferred by the AJCC and NCCN and the II/IIIC rating designated by the AAD in the latest version of their melanoma guidelines.
NCCN says this on p. ME-2 regarding early stages of melanoma Ongoing prospective investigation will further inform the utility of gene expression profiling (GEP) tests and multivariable nomograms/risk calculators (eg, melanomarisk.org.au/snlland; mskcc.org/nomograms/melanoma/sentinel_lymph_node_metastasis), and other decision analytical models for SLNB risk prediction (Miller JR 3rd, et al. JAMA Netw Open 2023;6:e236356 and Bartlett EK, et al. Ann Surg Oncol 2024 Oct 29. Epub ahead of print. doi: 10.1245/ s10434-024-16379-2). ”
Danielle P. Dubin et al, Level of Evidence Review for a Gene Expression Profile Test for Cutaneous Melanoma, American Journal of Clinical Dermatology December 2019, Volume 20, Issue 6, pp 763–770| Cite as

CK, Halpern AC, Johnson TM, et al. Guidelines of care for the management of primary cutaneous melanoma. J Am Acad Dermatol 2011; 65(5): 1032-1047.

Pedram Gerami, Robert W. Cook, Jeff Wilkinson, Maria C. Russell, Navneet Dhillon, Rodabe N. Amaria, Rene Gonzalez, Stephen Lyle, Clare E. Johnson, Kristen M. Oelschlager, Gilchrist L. Jackson, Anthony J. Greisinger, Derek Maetzold, Keith A. Delman, David H. Lawson, and John F. Stone, Development of a Prognostic Genetic Signature to Predict the Metastatic Risk Associated with Cutaneous Melanoma. CCR-13-3316  Published 1 January 2015

NATIONAL CRITERIA/PEER REVIEWED PUBLICATION/LITERATURE

Engelhardt, K., Wayne, J.D., Bilimoria, K.Y. Editorial: Should We Abandon TNM Staging in Favor of Gene Profiles in Node-Positive Melanoma? Annals of Surgical Oncology January 2017. 24 (1): 3-5. https://doi.org/10.1245/s10434-016-5576-6

Keller, J., Diggs, L. P., & Hsueh, E. C. (2017). Prognostic molecular testing in melanoma: ready for prime time? Melanoma Management, 4(4), 171–174. http://doi.org/10.2217/mmt-2017-0013

Zager, J.S., Gastman, B.R., Leachman, S., Gonzalez, R.C., Fleming, M.D., et al. Performance of a prognostic 31-gene expression profile in an independent cohort of 523 cutaneous melanoma patients. BMC Cancer 2018 Feb 5; 18 (1): 130 doi: 10.1186/s12885-018-4016-3.

Pedram GeramiGene expression profiling for molecular staging of cutaneous melanoma in patients undergoing sentinel lymph node biopsy. JAAD May 2015Volume 72, Issue 5, Pages 780785.e3

NCCN, Melanoma ME-2 2025