First and only prospective blinded data confirm the Merlin CP-GEP (Clinico pathological-Gene Expression Profiling) Test accurately stratifies melanoma patients by sentinel node metastasis risk, showing a greater than three-fold difference between High-Risk and Low-Risk groups
Largest prospective gene expression profile study in melanoma to date provides quantitative guidance for clinicians regarding the clinical utility of Merlin CP-GEP testing in guiding sentinel lymph node biopsy (SLNB) decision-making
SkylineDx today announced that results from its landmark MERLIN_001 trial, the largest prospective evaluation of a genomic test in cutaneous melanoma, have been published in the October 2025 issue of JAMA Surgery, the most cited surgery journal in the world. The study demonstrates that the Merlin CP-GEP Test stratified T1-T3 melanomas with clearly distinct risk levels for sentinel node metastasis: patients with a High-Risk result had a three-fold higher rate of sentinel node metastasis compared to those with a Low-Risk result (23.8% vs. 7.1%) overall.
The MERLIN_001 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.
“This study represents a major step forward in evaluating personalized melanoma care,” said Vernon Sondak, MD, MERLIN_001 Principal Investigator and chair of the Cutaneous Oncology Department at Moffitt Cancer Center in Tampa, Florida. “Studying the Merlin CP-GEP Test’s ability to distinguish patients’ risk of sentinel node metastasis with a rigor and precision no other test or nomogram can match. Our results show that the test adds a level of accuracy above current clinical factors alone, even when factors like mitotic rate and histologic subtype are taken into account, and this kind of knowledge ultimately allows patients and surgeons to make better decisions about when sentinel node biopsy should be part of the management of clinically localized melanoma. In appropriately selected patients, this test can add value for shared decision-making.”
Key Findings
- Across the study population, the Merlin CP-GEP Test stratified melanomas into two distinct risk groups: High-Risk patients had greater than a three-fold likelihood of SLN metastasis (23.8%) compared to Low-Risk patients (7.1%). Overall, 37.0% of patients were Low-Risk while 63.0% were High-Risk. Importantly, the test was successful in 97.7% of submitted samples.
- In patients aged 65 and older, where comorbidities can be more prevalent, the test identified 57.9% as High-Risk, with a positive SLNB rate of 20.3%, versus a 6.6% positive SLNB rate for Low-Risk cases.
- In head and neck melanomas, where SLNB can be technically difficult and can carry higher morbidity, the Merlin CP-GEP test identified High-Risk cases with a 26.7% SLN rate and Low-Risk cases with a 4.9% SLN (five-fold risk increase in the High-Risk vs. the Low-Risk groups).
- Across all ages and primary sites, cases with clinical Stage IB melanoma were classified as Low-Risk 49.3% of the time, with a 6.5% positive SLNB rate, compared with an 18.3% rate for High-Risk cases.
