SkylineDx's MERLIN_001 Trial Validates Merlin CP-GEP Test for Melanoma Risk Stratification

Landmark MERLIN_001 Trial Published in JAMA Surgery

SkylineDx has made headlines with the publication of its groundbreaking MERLIN_001 trial in the October 2025 issue of JAMA Surgery, marking a significant milestone in melanoma research. This study is the largest prospective evaluation of a genomic test specifically for cutaneous melanoma, confirming the predictive capabilities of the Merlin CP-GEP (Clinico-pathological Gene Expression Profiling) Test.

The findings from the trial demonstrated the ability of the Merlin CP-GEP Test to accurately stratify patients based on their risk for sentinel node metastasis. Notably, patients categorized as High-Risk exhibited a rate of sentinel node metastasis that was over three times higher compared to those classified as Low-Risk (23.8% vs. 7.1%). With a study population of 1,761 melanoma patients from prestigious academic institutions, the trial's results are poised to influence clinical decisions in melanoma care.

Key Insights from the MERLIN_001 Trial

One of the major takeaways from the MERLIN_001 trial is its clear stratification of risk associated with sentinel node metastasis in melanoma patients. Overall, 63% of the patients were identified as High-Risk, while 37% were placed in the Low-Risk category. The success rate of the test was noteworthy, with a 97.7% success in analyzed samples, providing strong evidence for its clinical utility.

In specific demographics, particularly among patients over 65 years of age—who often experience more comorbidities—57.9% tested High-Risk, correlating with a 20.3% positive sentinel lymph node biopsy (SLNB) rate. Contrast this with the Low-Risk group, which had only a 6.6% positive SLNB rate. Similarly, in notably challenging cases of head and neck melanomas—associated with technical difficulties for SLNB—the test identified High-Risk individuals with a sentinel node rate of 26.7%, compared to just 4.9% in Low-Risk patients. This presents a five-fold increase in risk for those identified as High-Risk, emphasizing the clinical relevance of the test.

Additionally, patients diagnosed with clinical Stage IB melanoma were classified as Low-Risk 49.3% of the time, demonstrating a significant 6.5% positive SLNB rate versus 18.3% for High-Risk counterparts.

Advancing Personalized Care in Melanoma

Dr. Vernon Sondak, the Principal Investigator of the MERLIN_001 trial and chair of the Cutaneous Oncology Department at Moffitt Cancer Center, emphasized the trial's implications for personalized melanoma care. He noted the precision of the Merlin CP-GEP Test over traditional nomograms, suggesting that it adds a valuable layer of accuracy to current clinical decision-making practices. With this test in their arsenal, healthcare professionals can make more informed choices about sentinel node biopsy, ultimately empowering shared decision-making with patients.

Understanding the Merlin CP-GEP Test

The Merlin CP-GEP Test is a unique, non-invasive prediction model crafted for patients with cutaneous melanoma. It stands out as the only commercially available gene expression profiling test that integrates clinical and pathologic variables into one comprehensive algorithm. Designed to provide a binary classification system as High-Risk or Low-Risk, this test aligns with evidence-based guidelines for cancer treatment and management.

Developed in collaboration with the Mayo Clinic and SkylineDx, the advanced CP-GEP model has undergone rigorous clinical validation and is now available in both the United States and Europe. This innovative approach aims to greatly enhance patient outcomes by accurately assigning risk categories that dictate appropriate surgical interventions.

SkylineDx is at the forefront of research in molecular diagnostics, particularly in oncology, inflammatory, and infectious diseases. The company's commitment to bridging the gap between academic discoveries and practical diagnostic applications is evident through its initiatives, including partnerships with global diagnostic service providers.

For more information about the Merlin CP-GEP Test, additional resources can be accessed via falconprogram.com and merlinmelanomatest.com.

SkylineDx continues to contribute significantly to the landscape of melanoma diagnostics, positioning itself as a leader in improving clinical outcomes through precision medicine.

Conclusion

The publication of the MERLIN_001 trial results signifies a pivotal moment in the field of melanoma research and management. With its validation of the Merlin CP-GEP Test, SkylineDx lays the groundwork for a future where tailored melanoma treatments can be standard, ultimately enhancing the quality of care for patients affected by this challenging disease.