SkylineDx has unveiled groundbreaking findings from the largest prospective multicenter melanoma gene expression profile (GEP) trial, demonstrating the clinical utility of their Merlin CP-GEP test in revolutionizing melanoma risk assessment and treatment planning.
Transforming Sentinel Lymph Node Biopsy Decision-Making
The MERLIN_001 trial, presented at SSO 2025, evaluated the Merlin CP-GEP test's ability to accurately identify melanoma patients who could safely forgo sentinel lymph node biopsy (SLNB) surgery. The test combines clinicopathologic variables with gene expression profiling to stratify patients into high or low risk categories for nodal metastases.
In a cohort of 31 T1a patients with adverse features, the Merlin test identified 80.6% as Low Risk with a remarkable 100% negative predictive value (NPV), indicating these patients could potentially avoid unnecessary SLNB surgery. Among 479 T1b patients, 67.6% were classified as Low Risk with a 94.8% NPV, suggesting their risk of metastases was approximately 5%.
Perhaps most significant were the findings for T2a melanoma patients, who typically have an SLN positivity rate of 15.5%. The Merlin test identified 36.6% of these patients as Low Risk with a 91.9% NPV, effectively reducing their metastatic risk below the 10% threshold typically used for recommending SLNB surgery.
Dr. Tina Hieken, a lead investigator in the study, emphasized the transformative potential: "The MERLIN_001 study provides a transformative approach to melanoma risk assessment, ensuring that we can better personalize care for our patients. The test not only refines risk stratification but also addresses critical subgroups, such as head and neck melanoma patients and elderly individuals, who often face complex treatment decisions."
Special Populations Benefit Significantly
The test showed exceptional performance in head and neck melanoma patients, a group that faces unique challenges with SLNB surgery due to complex lymphatic drainage and vital anatomical structures. In this population, the Merlin test identified 43.3% as Low Risk with a 95.1% NPV, offering these patients the possibility of avoiding potentially complicated surgical procedures.
"By leveraging this groundbreaking tool, we can confidently guide SLNB recommendations and optimize patient outcomes," Dr. Hieken added.
Beyond SLNB: Predicting Long-Term Outcomes
In a separate study presented at the 2025 World Congress of Melanoma, Dr. Teresa Amaral from the University of Tübingen, Germany, demonstrated the Merlin CP-GEP test's ability to predict relapse and long-term survival outcomes, addressing a critical gap in current melanoma staging methods.
The study analyzed 930 stage I/II melanoma patients who did not undergo SLNB, with 94.5% classified as Merlin Low-Risk and 5.5% as Merlin High-Risk. The results were striking:
- Patients identified as Low-Risk showed 5-year and 10-year relapse-free survival (RFS) rates of 96% and 94.5%, respectively
- High-Risk patients were approximately 20 times more likely to experience recurrence, with 5-year and 10-year RFS rates of just 37.5%
- High-Risk patients also showed significantly increased rates of distant metastasis and melanoma-specific death
Dr. Amaral noted, "The results of this study highlight the potential of the Merlin CP-GEP test to redefine risk assessment for melanoma patients. By identifying high-risk individuals who may not have undergone SLNB, we can better personalize treatment decisions, ultimately improving long-term outcomes for patients."
Implications for Clinical Practice
The Merlin CP-GEP test represents a significant advancement in melanoma care as the only commercially available GEP test that combines clinicopathologic variables with gene expression profiling into a single integrated algorithm. It provides a binary stratification of patients based on their risk for metastasis, aligning with evidence-based cancer treatment guidelines.
Dr. Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx, suggested potential therapeutic implications: "These results highlight the power of CP-GEP in helping clinicians identify high-risk patients, even in the absence of SLNB status. Additional research is needed but potentially the Merlin High-Risk patients could benefit from systemic therapy to overcome their risk of recurrence, as their RFS is similar to that of patients who are currently eligible for immunotherapy."
Dharminder Chahal, CEO of SkylineDx, emphasized the company's commitment to rigorous validation: "The MERLIN_001 study results are a breakthrough in melanoma care. As the only company to have conducted this large, prospective, blinded trial of the Merlin CP-GEP test in collaboration with esteemed academic institutions in the U.S., we are committed to empowering clinicians with a rigorously validated test backed by high-quality evidence, ensuring patients receive the most informed care possible."
A New Standard in Melanoma Risk Assessment
Traditional melanoma staging methods, including SLNB status alone, have limitations, as node-negative patients can still experience relapse and melanoma-related death. The Merlin CP-GEP test addresses this gap by identifying tumors at high risk for relapse that would otherwise be missed by traditional clinical and pathological evaluations.
The test has been launched in both the United States and Europe, with SkylineDx collaborating with diagnostic service providers globally to increase patient access. With operations in Rotterdam, the Netherlands, and a CAP/CLIA certified laboratory in San Diego, California, SkylineDx continues to bridge the gap between academic research and commercially available diagnostic products with high clinical utility.
As melanoma treatment continues to evolve toward more personalized approaches, the Merlin CP-GEP test represents a significant step forward in ensuring patients receive appropriate care based on their individual risk profiles, potentially sparing many from unnecessary procedures while identifying those who may benefit from more aggressive treatment strategies.
