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. THere are many studies about it and two meta-analysies have been published and are supportive of benefit of this test. However, NCCN v2.205 update to ME-2A. “based on the current evidence the NCCN melanoma panel does not recommend incorporation of commercially available GEP tests in melanoma care. The use of GEP according to specific AJCC-8 melanoma stage (before or after SLNB) requires further prospective investigation in large contemporary datasets of unselected patients.” As such, this is an E/I approach.

Guenther JM, Ward A, Martin BJ, et al. A prospective, multicenter analysis of recurrence-free survival after sentinel lymph node biopsy decisions influenced by the 31-GEP. Cancer Med. Published online April 1, 2025. doi:10.1002/cam4.70839

Guenther JM, Ward A, Martin BJ, et al. A prospective, multicenter analysis of the integrated 31-gene expression profile test for sentinel lymph node biopsy (i31-GEP for SLNB) test demonstrates reduced number of unnecessary SLNBs in patients with cutaneous melanoma. World J Surg Onc. 2025;23(1):5.

Cook RW, Middlebrook B, Wilkinson J, et al.Analytic validity of DecisionDx-Melanoma, a gene expression profile test for determining metastatic risk in melanoma patients. Diagn Pathol 2018;13:13
Guideline/Criteria References:

NCCN Melanoma 2025 (ME-C, 8)