SkylineDx said its Merlin CP-GEP clinicopathologic gene expression profiling assay received FDA breakthrough device designation for early-stage cutaneous melanoma risk assessment. The binary test stratifies patients into high- or low-risk categories for metastasis and is intended to support clinical decision-making on sentinel lymph node biopsy. The company said the designation was supported by data from the MERLIN_001 prospective multicenter blinded clinical trial. SkylineDx reported Merlin is already launched in the U.S. and Europe as part of risk assessment and follow-up discussions. The breakthrough designation underscores the growing role of gene expression profiling in guiding surgical and surveillance decisions for early cancer stages where standard pathology alone may not refine metastatic risk.