SkylineDx's Merlin CP-GEP Earns FDA Breakthrough Device Designation for Early-Stage Melanoma Risk Assessment
核心洞察
The FDA granted Breakthrough Device Designation to SkylineDx (搜索)'s Merlin CP-GEP (搜索), a molecular diagnostic test for guiding treatment decisions in early-stage cutaneous melanoma (搜索).
Merlin CP-GEP (搜索) is the first and only melanoma gene expression profiling test to hold both FDA Breakthrough Device Designation and inclusion in NCCN Clinical Practice Guidelines.
The designation is supported by data from the MERLIN_001 trial, the largest prospective multicenter blinded clinical study of its kind in cutaneous melanoma (搜索).
SkylineDx (搜索) announced on July 1, 2026 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Merlin CP-GEP (搜索), a clinicopathologic gene expression profile test designed to support risk assessment and clinical decision-making in patients with early-stage cutaneous melanoma (搜索). The designation marks a significant regulatory milestone for the Rotterdam-based biotechnology company and further validates the test's clinical utility in a patient population where accurate metastatic risk assessment is critical for guiding management.
The FDA's Breakthrough Devices Program is designed to expedite the development and review process for novel technologies that may provide more effective diagnosis or management of life-threatening or irreversibly debilitating diseases. With this designation, Merlin CP-GEP (搜索) becomes the first and only melanoma gene expression profiling test to hold both FDA Breakthrough Device Designation and inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for T1b and T2a cutaneous melanoma (搜索) patients.
Clinical Evidence from the MERLIN_001 Trial
The Breakthrough Device Designation is supported by data from the MERLIN_001 clinical trial, the largest prospective, multicenter, blinded study of its kind in cutaneous melanoma (搜索). The trial demonstrated Merlin CP-GEP (搜索)'s ability to improve patient risk stratification when used alongside established clinical criteria. Specifically, the test supports patient selection for sentinel lymph node biopsy procedures, may inform discussions regarding follow-up strategies, and facilitates shared decision-making between healthcare providers and patients.
The NCCN Guidelines (Version 2.2026) already recognize CP-GEP as a predictive gene expression profiling test that may be used to support metastatic risk assessment and clinical decision-making in T1b and T2a melanoma patients — a clinically important population in which accurate assessment of metastatic potential is critical for guiding management.
How Merlin CP-GEP (搜索) Works
Merlin CP-GEP (搜索) is a non-invasive prediction model that uniquely combines clinicopathologic variables with gene expression profiling into a single integrated algorithm. It is currently the only commercially available GEP test that provides a binary stratification of all patients based on being high or low risk for metastasis, thereby assigning them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention, and screening guidelines.
The advanced CP-GEP model was developed through a collaboration between Mayo Clinic and SkylineDx (搜索) and has been clinically validated in multiple international studies. The test has been launched commercially in both the United States and Europe, with SkylineDx collaborating with diagnostic service providers globally to expand patient access.
Executive Perspective
"Breakthrough Device Designation underscores the potential of Merlin CP-GEP (搜索) to advance personalized melanoma care and support more informed, patient-centered treatment decisions," said Dharminder Chahal, Chief Executive Officer of SkylineDx (搜索). "Patients deserve access to the best available tools supported by rigorous clinical evidence and recognized in clinical practice guidelines."
Company Background
SkylineDx (搜索) is a biotechnology company focused on the research and development of molecular diagnostics in oncology, dermatology, inflammatory diseases, and infectious diseases. The company bridges the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility. Headquartered in Rotterdam, the Netherlands, SkylineDx maintains a U.S. presence with a CAP- and CLIA-certified laboratory in San Diego, California, and a nationwide commercial service organization supporting the U.S. market.