Results from the 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, demonstrating that the Merlin CP-GEP Test can accurately stratify patients by risk of sentinel node metastasis. The study, which 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, showed that patients with a High-Risk result had a 23.8% rate of sentinel node metastasis compared to 7.1% for those with a Low-Risk result—a greater than three-fold difference.
“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. “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.”
Key findings revealed that across the study population, 37.0% of patients were classified as Low-Risk while 63.0% were High-Risk, with a 97.7% success rate for the test. In patients aged 65 and older, where comorbidities can be more prevalent, the test identified 57.9% as High-Risk, with a positive sentinel lymph node biopsy (SLNB) rate of 20.3% versus 6.6% for Low-Risk cases. In head and neck melanomas, where SLNB can be technically difficult and carry higher morbidity, High-Risk cases had a 26.7% SLN rate and Low-Risk cases a 4.9% rate—a five-fold increase. 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 18.3% for High-Risk cases.
The Merlin CP-GEP Test is a non-invasive prediction model that combines clinicopathologic variables with gene expression profiling into a single integrated algorithm, providing a binary stratification of patients as High or Low Risk for metastasis. It is the only commercially available GEP test that assigns patients to appropriate surgical action categories as listed in evidence-based cancer treatment guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx and has been clinically validated in multiple studies globally. The test has been launched in the United States and Europe as Merlin, and SkylineDx collaborates with diagnostic service providers globally to increase patient access. More information can be obtained at www.falconprogram.com and www.merlinmelanomatest.com.
The MERLIN_001 trial results published in JAMA Surgery can be found at https://doi.org/10.1001/jamasurg.2025.4399.
