FDA Grants Breakthrough Status to SkylineDx Melanoma Diagnostic Test
The U.S. Food and Drug Administration has granted Breakthrough Device Designation to the Merlin CP-GEP, a diagnostic tool designed to refine risk assessment for patients with early-stage cutaneous melanoma. This recognition accelerates the development of a technology already integrated into current NCCN clinical practice guidelines for the disease.
Developed by SkylineDx in collaboration with the Mayo Clinic, the Merlin CP-GEP test serves as an integrated model that combines clinicopathologic variables with gene expression profiling. By providing a clear high or low-risk stratification for metastasis, the tool assists clinicians in determining the necessity of sentinel lymph node biopsies and establishing long-term follow-up strategies for patients with T1b and T2a stage melanoma.
Validation for the designation stems from the MERLIN_001 study, the largest prospective multi-center blinded clinical trial conducted within this specific patient population. According to SkylineDx CEO Dharminder Chahal, the designation reinforces the test’s role in advancing personalized care. The diagnostic, currently available in the United States and Europe, represents a shift toward data-driven decision-making in dermatology, aiming to bridge the gap between academic gene expression research and standardized clinical application.
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