SkylineDx received FDA breakthrough device designation for Merlin CP-GEP, a clinicopathologic gene expression profiling assay designed to support risk assessment and clinical decision-making in early-stage cutaneous melanoma. The test is intended to help stratify patients by predicted metastasis risk and guide sentinel lymph node biopsy selection. The designation cites evidence from the prospective multicenter MERLIN_001 trial, and SkylineDx said the assay aligns with NCCN Clinical Practice Guidelines in Oncology for use in T1b and T2a melanoma risk assessment discussions. The test was developed with Mayo Clinic and is already launched in the US and Europe as Merlin. Breakthrough status can accelerate FDA review and underscores the expanding role of gene expression tests in surgical decision points beyond standard clinicopathologic staging.