This is a female patient who was diagnosed with malignant melanoma who had a Decision X-Melanoma testing performed. As reported by the authors Sondak, V. K., & Messina, J. L. (2016), "A similar (but genetically unrelated) gene expression profile test is now commercially available for cutaneous melanoma (DecisionDx-Melanoma; Castle Biosciences). This test has not yet been evaluated in the kind of prospective clinical study that demonstrated the value of the uveal melanoma profile, nor is the scientific basis for including the component genes as well characterized. The clinical value of this test remains unclear, and the National Comprehensive Cancer Network (NCCN) Guidelines for Melanoma state 'while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low- versus high-risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas (before or following SLNB) is not recommended outside of a clinical study (trial)."' The carrier's denial of coverage for the DecisionDx-Melanoma Testing performed should be upheld.

This is a female patient who was diagnosed with malignant melanoma with a shave biopsy. She underwent a biopsy of her right arm, which was indicative of malignant melanoma. Her physician ordered the Decision DX-Melanoma Assay. The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. The DecisionDx genetic testing has not been shown to improve the net health outcome of patients with cutaneous melanoma. This testing has not been shown to be beneficial in patients with uveal melanoma or in patients with cutaneous melanoma. DecisionDx-Melanoma Testing does not have final approval from the appropriate regulatory bodies for this diagnosis. This patient is not a good candidate for DecisionDx-Melanoma Testing. There is no clinically significant benefit arising from the DecisionDx testing. The DecisionDx-Melanoma Testing is not the best available treatment for this patient at this time. The carrier's denial of coverage for the DecisionDx-Melanoma Testing performed should be upheld.

Diagnosis: Malignant Melanoma Treatment: DecisionDx-Melanoma Testing The insurer denied the DecisionDx-Melanoma Testing. The denial was upheld. This is a female patient with a history of malignant melanoma. She underwent a biopsy of her right arm which revealed malignant melanoma. The specimen was sent for Decision DX Melanoma assay. The DecisionDx-Melanoma test is not recommended by the panel of expert authors of UpToDate. The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. DecisionDx-Melanoma testing does not need final approval from the appropriate regulatory body for this diagnosis as the facility is overseen by Clinical Laboratory Improvement Amendments (CLIA) and does not need to be Food and Drug Administration (FDA) approved. The patient is not a good candidate for DecisionDx-Melanoma testing. DecisionDx-Melanoma testing is not the best available treatment for the patient at this time, as the literature recommended that an annual routine physical examination, including a full skin assessment and palpation of the regional lymph nodes, would be appropriate for patients at risk. More frequent visits would be appropriate for patients with stage III or stage IV disease. The carrier's denial of coverage for the DecisionDx-Melanoma Testing performed should be upheld.

1) Berger AC, Davidson RS, Poitras JK, et al. (2016). "Clinical impact of a 31-gene expression profile test for cutaneous melanoma in 156 prospectively and consecutively tested patients." Curr Med Res Opin, 2016; 32:1599. 2) Sondak, V. K., & Messina, J. L. (2016). "Prediction is Difficult, Especially About the Future: Clinical Prognostic Tools in Melanoma." Annals of surgical oncology, 23(9), 2730-2732. 3) National Comprehensive Cancer Network. 4) Weiss, S. A., Hanniford, D., Hernando, E., & Osman, I. (2015). "Revisiting determinants of prognosis in cutaneous melanoma." Cancer, 121(23), 4108-4123.

1) Swetter et al. Guidelines of care for the management of primary cutaneous melanoma. 2019 J Am Acad Derm 80:208 2) 5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results (INTEGRATE) clinical trials. NCT02355574

1) Castle Biosciences Inc. (2016). "DecisionDx-Melanoma Summary." Retrieved from http://skinmelanoma.com/managed-care-professionals/decisiondx-melanoma-…. 2) National Comprehensive Cancer Network. "Melanoma." NCCN Clinical Practice guidelines in Oncology, Version 1.2017 - November 16, 2016. 3) Buzaid, A. C., Gershenwald, J. E. (2018). "Staging work-up and surveillance after treatment of melanoma." IN. Atkins, M. B., Tsao, H., Ross, M. E. (Eds.) UpToDate. Waltham, MA. 4) Buzaid, A. C., Gershenwald, J. E., (2018) "Tumor node metastasis (TNM) staging system and other prognostic factors in cutaneous melanoma." IN. Atkins, M. B., Ross, M. E. (Eds.) UpToDate, Waltham, MA. Retrieved from https://www.uptodate.com/contents/tumor-node-metastasis-tnm-staging-sys…. 5) Stone, M. (2018). "Evaluation and treatment of regional lymph nodes in melanoma." IN. Atkins, M. B., Berman, R. S., Ross, M. E. (Eds.) UpToDate, Waltham, MA. Retrieved from https://www.uptodate.com/contents/evaluation-and-treatment-of-regional-….