Curated News
By: NewsRamp Editorial Staff
October 23, 2025
Melanoma Test Shows 3-Fold Risk Stratification in Landmark Study
TLDR
- SkylineDx's Merlin CP-GEP Test provides a clinical advantage by identifying melanoma patients who truly need sentinel node biopsy, optimizing surgical resource allocation and patient outcomes.
- The Merlin CP-GEP Test combines clinicopathologic variables with gene expression profiling to stratify melanoma patients into High-Risk and Low-Risk groups for sentinel node metastasis.
- This test enables more personalized melanoma care, reducing unnecessary surgeries for low-risk patients while ensuring high-risk patients receive appropriate intervention for better health outcomes.
- The largest prospective melanoma study revealed Merlin CP-GEP can identify patients with five-fold higher sentinel node metastasis risk in challenging head and neck cases.
Impact - Why it Matters
This breakthrough in melanoma diagnostics represents a significant advancement in personalized cancer care that directly impacts patient outcomes and treatment decisions. For the thousands of people diagnosed with melanoma each year, the Merlin CP-GEP test provides unprecedented accuracy in determining who truly needs invasive sentinel lymph node biopsy procedures versus who can safely avoid them. This matters because sentinel node biopsies carry risks including infection, lymphedema, and nerve damage, while also adding substantial healthcare costs. By accurately identifying low-risk patients who can forego this procedure, the test reduces unnecessary surgeries, minimizes complications, and decreases healthcare expenses. For high-risk patients, it ensures they receive the necessary interventions promptly. In an era where precision medicine is transforming oncology, this test exemplifies how genomic technology can optimize treatment pathways, improve quality of life, and make cancer care more efficient and patient-centered.
Summary
SkylineDx has announced groundbreaking results from its landmark MERLIN_001 trial, the largest prospective evaluation of a genomic test in cutaneous melanoma, published in the prestigious October 2025 issue of JAMA Surgery. The study demonstrates that the Merlin CP-GEP (Clinico pathological-Gene Expression Profiling) Test accurately stratifies melanoma patients by sentinel node metastasis risk, showing a remarkable three-fold difference between High-Risk and Low-Risk groups. Patients with a High-Risk result had a 23.8% rate of sentinel node metastasis compared to just 7.1% for Low-Risk patients, providing quantitative guidance for clinicians regarding the clinical utility of Merlin CP-GEP testing in guiding sentinel lymph node biopsy decision-making.
The trial enrolled 1,761 patients across leading U.S. academic cancer centers including the Mayo Clinic, University of Louisville, University of Michigan, Huntsman Cancer Institute, University of Kentucky, Emory University, Duke University, Memorial Sloan Kettering Cancer Center, and Moffitt Cancer Center. According to Dr. Vernon Sondak, MERLIN_001 Principal Investigator and chair of the Cutaneous Oncology Department at Moffitt Cancer Center, this study represents a major step forward in personalized melanoma care, providing rigor and precision no other test or nomogram can match. The test adds accuracy above current clinical factors alone, even when considering mitotic rate and histologic subtype, ultimately allowing patients and surgeons to make better decisions about when sentinel node biopsy should be part of melanoma management.
The Merlin CP-GEP Test successfully stratified 37.0% of patients as Low-Risk and 63.0% as High-Risk, with the test achieving a 97.7% success rate across submitted samples. Particularly impactful results emerged in specific patient populations: among patients aged 65 and older, the test identified 57.9% as High-Risk with a 20.3% positive SLNB rate versus 6.6% for Low-Risk cases. In head and neck melanomas, where SLNB carries higher morbidity, the test showed a five-fold risk increase between High-Risk (26.7% SLN rate) and Low-Risk groups (4.9% SLN rate). The test's performance across all ages and primary sites demonstrates its potential to transform melanoma care through more precise risk assessment and personalized treatment decisions.
Source Statement
This curated news summary relied on content disributed by citybiz. Read the original source here, Melanoma Test Shows 3-Fold Risk Stratification in Landmark Study
