SkylineDx has announced compelling results from a Danish multicenter validation study demonstrating that its Merlin Assay (CP-GEP) can significantly reduce the need for sentinel lymph node biopsy (SLNB) in early-stage melanoma patients. Published in the Journal of Surgical Oncology, the study analyzed 536 patients with pT1–pT3 cutaneous melanoma who had undergone SLNB between 2010 and 2015. The genomic test accurately identified a subset of patients—especially those in the pT1 and pT2 categories—who were at low risk for nodal metastasis and could have safely avoided SLNB. The assay achieved a 72.7% SLNB reduction rate among pT1 patients, with a high negative predictive value (NPV) of 94.5%.

Compared to widely used clinical nomograms for SLN metastasis prediction, the Merlin Assay demonstrated a notably greater ability to reduce unnecessary SLNB procedures. Across the broader pT1–pT3 patient group, 41% were classified as low risk by CP-GEP and could have forgone surgery—far exceeding the 7.8% reduction achieved using standard nomogram tools. These findings underscore the assay’s clinical utility in personalizing surgical decisions, improving patient safety, and reducing the use of invasive procedures under general anesthesia, which carry risks of complications and strain on healthcare resources.

As the only GEP-based tool specifically developed to identify melanoma patients with a low likelihood of sentinel lymph node involvement, SkylineDx's Merlin test represents a critical advancement in precision oncology. Its consistent performance across independent validation cohorts highlights its reliability and potential for integration into clinical practice. Looking ahead, the Merlin Assay could help redefine SLNB decision-making in melanoma care, enabling a more tailored, evidence-driven approach to risk stratification while optimizing outcomes and resource allocation in dermatologic oncology.

MedTech Spectrum's Summary

Significant SLNB Reduction: SkylineDx’s Merlin Assay demonstrated the ability to reduce sentinel lymph node biopsies by over 40% in early-stage melanoma patients, especially in the pT1 subgroup, while maintaining a high negative predictive value.

Superior to Existing Tools: The CP-GEP test outperformed standard nomograms in identifying low-risk patients, offering a more effective, non-invasive alternative for refining SLNB decision-making in clinical practice.

Toward Precision Melanoma Care: With consistent validation across cohorts, the Merlin Assay is positioned to become a key component in personalized melanoma management, improving patient outcomes and reducing unnecessary surgical burden.