New Data from SkylineDx Demonstrates Merlin CP-GEP Test's Superior Melanoma Risk Stratification
- New data analysis clarifies misleading benchmarks released by a competitor; separate SkylineDx analysis demonstrates Merlin CP-GEP Test provides stronger metastatic-risk stratification and superior predictive accuracy for SLNB outcomes compared to 31-GEP/i31-SLNB, when evaluated under harmonized and scientifically rigorous conditions
- Recent publication in early-stage melanoma shows Merlin CP-GEP Test correctly identifies High-Risk patients with a >10% SLNB positivity risk—exceeding risk levels associated with traditional high-risk features such as age, lymphovascular invasion, and mitotic rate, supporting its role in identifying patients warranting a surgical referral
ROTTERDAM, Netherlands and SAN DIEGO, Calif., Dec. 18, 2025 /PRNewswire/ -- SkylineDx today announced 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.
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."
References:
1 Michael L. Chen, Isabella Joy de Vere Hunt, Esther M. John, Martin A. Weinstock, Susan M. Swetter, Eleni Linos Differences in Thickness-Specific Incidence and Factors
Associated With Cutaneous Melanoma in the US From 2010 to 2018; JAMA Oncology, March 2022Differences in Thickness-Specific Incidence and Factors Associated With Cutaneous Melanoma in the US From 2010 to 2018 | Dermatology | JAMA Oncology | JAMA Network
2 Domenico Bellomo, Christian Gross, Ani Pazhava, Charles Perniciaro, Jvalini Dwarkasing, Alexander Meves Flawed Benchmarks and Biased Cohorts: Reassessing the Evidence for CP–GEP (Merlin) Versus 31–GEP (DecisionDx–Melanoma) - Bellomo - International Journal of Dermatology - Wiley Online Library International Journal of Dermatology.
3 Peter A Prieto, Laura K Ferris, Michael J Guenther Comparing Two Gene Expression Profile Tests to Standard of Care for Identifying Patients With Cutaneous Melanoma at Low Risk of Sentinel Lymph Node Positivity - PubMed Cancer Diagnosis & Prognosis
4 Wesley Yu et al .CP-GEP identifies high-risk T1a melanoma patients beyond established adverse features - Journal of the American Academy of Dermatology 2025 Oct
About the Merlin CP-GEP Test
CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. In addition, it is the only GEP test that provides binary stratification of all patients into High or Low Risk for metastasis, allowing clinicians to assign patients to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention, and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com.
About SkylineDx
SkylineDx is a biotechnology company focused on research and development of molecular diagnostics in oncology, and inflammatory and infectious diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. Headquartered in Rotterdam, the Netherlands, SkylineDx maintains a strong U.S. presence with a CAP/CLIA certified laboratory in San Diego, California, and a nationwide commercial service organization that ensures full operational support across the U.S. market. To learn more about SkylineDx, please visit www.skylinedx.com.
Media Contact:
ICR Healthcare
Alexis Feinberg
+1 203-939-2225
Alexis.feinberg@icrhealthcare.com
SkylineDx contact:
Linda Forlani
press@skylinedx.com
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