Two peer-reviewed studies demonstrate superior risk stratification compared to traditional clinicopathologic features and competitor testing.
SkylineDx has released new data from two peer-reviewed publications reinforcing the clinical value of its Merlin CP-GEP Test for melanoma risk stratification, demonstrating improved accuracy over traditional assessment methods and competitor genomic tests.
The studies show that the Merlin CP-GEP Test, validated in the MERLIN_001 prospective gene expression profiling study, identifies patients with a threefold increased risk of sentinel lymph node biopsy (SLNB) positivity when classified as high-risk compared to low-risk patients. High-risk results consistently exceeded the 10% threshold referenced in major clinical guidelines.
Despite 75% of melanoma being diagnosed at an early T1 stage, the disease accounts for a disproportionate share of skin cancer mortality, with more than half of melanoma-related deaths occurring in patients who initially presented with early-stage disease.
Comparative Analysis Reveals Superior Performance
In one newly published peer-reviewed publication in International Journal of Dermatology, SkylineDx investigators analyzed a comparative assessment previously used to support the DecisionDx-Melanoma test. When patient cohorts were harmonized and 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. When evaluated under aligned conditions, the Merlin CP-GEP Test consistently delivered higher clinical utility than the competitor test.
T1a Melanoma Study Shows Clinical Value
A second analysis published in Journal of American Academy of Dermatology focused on early-stage T1a melanoma, showing that Merlin CP-GEP High-Risk results reliably identify patients with greater than 10% risk of SLNB metastasis. The study indicates these patients should be prioritized for surgical oncology consultation.
The research highlights that the Merlin CP-GEP Test outperforms traditional high-risk features including age, lymphovascular invasion, and mitotic rate, supporting its use as an additional tool in guiding SLNB decision-making.
“Melanoma clinicians need tools that are not only innovative but proven through rigorous, prospective, and blinded clinical validation,” says Alexander Meves, MD, Mayo Clinic, in a release. “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.”
About the Merlin CP-GEP Test
The CP-GEP test is a non-invasive prediction model for cutaneous melanoma patients and the only commercially available gene expression profiling test that combines clinicopathologic variables with gene expression profiling into a single integrated algorithm. It provides binary stratification of all patients into High or Low Risk for metastasis.
The test was developed by Mayo Clinic and SkylineDx and has been clinically validated in multiple studies globally. It is available in the United States and Europe as Merlin through collaborations with diagnostic service providers.
Rotterdam, Netherlands-based SkylineDx operates a CAP/CLIA certified laboratory in San Diego and maintains a nationwide commercial service organization in the US market.
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