On December 18, 2025 SkylineDx reported the release of new data from two complementary, peer-reviewed publications that reinforce the clinical value of the Merlin CP-GEP Test for melanoma risk stratification. Together, these studies demonstrate that prospectively validated genomic tools are essential to improve clinical decision-making and reduce both under- and overtreatment in early-stage melanoma.
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The Merlin CP-GEP Test, validated in the largest prospective gene expression profiling study in melanoma (MERLIN_001), demonstrated that a High-Risk result identifies patients with a threefold increased risk of SLNB positivity compared to Low-Risk, and consistently above the 10% threshold referenced in major guidelines.
Despite 75% of melanoma being diagnosed at an early T1 stage1, the disease still accounts for a disproportionate share of skin cancer mortality with more than half of melanoma-related deaths coming from patients who initially presented with "early-stage" disease. These findings reinforce a growing consensus across oncology: accurate, prospectively validated risk-assessment tools must be incorporated into standard-of-care, just as they are in breast, prostate, and thyroid cancer.
Analysis Clarifies Misleading Benchmarks in Competitor’s Prior Comparison
In a peer-reviewed publication2, SkylineDx investigators conducted a rigorous analysis of a comparative assessment3 used to support DecisionDx-Melanoma. When patient cohorts were harmonized and improper exclusions were corrected, the Merlin CP-GEP Test demonstrated superior metastatic-risk stratification and more accurate prediction of SLNB outcomes across real-world disease prevalence ranges. The analysis revealed that earlier comparisons relied on methodologically flawed cohorts and selectively chosen performance benchmarks, leading to conclusions that were not scientifically valid. When evaluated under aligned and transparent conditions, the Merlin CP-GEP Test consistently delivered higher clinical utility.
New T1a Publication Shows Merlin CP-GEP Test Identifies High-Risk Patients That Were Missed by Traditional Adverse Features
A newly published analysis4 in Journal of American Academy of Dermatology about early-stage T1a melanoma showed that Merlin CP-GEP High-Risk reliably identifies patients with >10% risk of SLNB metastasis, suggesting these individuals should be prioritized for surgical oncology consultation. The study highlights that Merlin CP-GEP Test outperforms using traditional high-risk features for assessment, including age, lymphovascular invasion, and mitotic rate, supporting the Test’s use as an additional high-risk tool in guiding SLNB decision-making.
"Melanoma clinicians need tools that are not only innovative but proven through rigorous, prospective, and blinded clinical validation," said Alexander Meves, MD, Mayo Clinic. "The Merlin CP-GEP Test has demonstrated an improvement over traditional clinicopathologic features and showed in the MERLIN_001 trial that High-Risk patients carry a significantly elevated risk—above key guideline thresholds. Tools with this level of evidence should be integrated into clinical pathways to support more individualized and accurate decision-making for our patients."
(Press release, SkylineDx, DEC 18, 2025, View Source [SID1234661544])