Gene Expression Test Supports Metastatic Risk Assessment in Melanoma

A gene expression profiling test has now received FDA Breakthrough Device Designation and is included in NCCN Guidelines to support metastatic risk assessment and clinical decision-making in this population.

Merlin CP-GEP, a clinicopathologic gene expression profile (CP-GEP) test from SkylineDx (Rotterdam, Netherlands), is designed to support risk assessment and clinical decision-making in patients with early-stage cutaneous melanoma. The FDA granted Breakthrough Device Designation to Merlin CP-GEP, recognizing its potential to address a significant unmet clinical need. It is positioned as the first and only melanoma gene expression profiling (GEP) test both designated as an FDA Breakthrough Device and included in the National Comprehensive Cancer Network (NCCN) Guidelines for T1b and T2a melanoma within stage IB disease.

The test functions as a non-invasive prediction model that integrates clinicopathologic variables with gene expression profiling in a single algorithm. It provides a binary stratification of patients into High- or Low-Risk for metastasis. Based on this result, patients are assigned to surgical action categories aligned with evidence-based treatment, prevention, and screening guidelines.

The Breakthrough Devices Program is intended to expedite the development and review of technologies that may provide more effective diagnosis or management of life-threatening or irreversibly debilitating diseases. The designation for Merlin CP-GEP is supported by data from MERLIN_001, highlighted as the largest prospective, multi-center, blinded clinical trial in cutaneous melanoma. When used with established clinical criteria, Merlin CP-GEP supports selection for sentinel lymph node biopsy, may inform follow-up discussions, and facilitates shared decision-making between providers and patients.

“Breakthrough Device Designation underscores the potential of Merlin CP-GEP to advance personalized melanoma care and support more informed, patient-centered treatment decisions. Patients deserve access to the best available tools supported by rigorous clinical evidence and recognized in clinical practice guidelines,” said Dharminder Chahal, Chief Executive Officer of SkylineDx.

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