The FDA granted breakthrough device designation to SkylineDx’s Merlin CP-GEP assay, a clinical-pathologic gene expression profiling test for risk assessment in early-stage cutaneous melanoma. The test is intended to support decision-making around sentinel lymph node biopsy and to inform follow-up strategies by stratifying patients into high- or low-risk categories. SkylineDx said the designation was supported by data from the MERLIN_001 prospective multicenter blinded trial. The company also noted Merlin’s alignment with National Comprehensive Cancer Network clinical practice guidance as a predictive gene expression profiling test in specific melanoma subgroups (T1b and T2a). If it reaches broader adoption, Merlin could strengthen the use of genomics-guided care in melanoma pathways that currently rely heavily on traditional clinicopathologic staging alone.