SkylineDx Presents New Data on Merlin CP-GEP Test at 2025 World Congress of Melanoma

SkylineDx, a leading innovator in molecular diagnostics for oncology, inflammatory, and infectious diseases, has announced that Dr. Teresa Amaral, MD, PhD, will be presenting new research at the 2025 World Congress of Melanoma (WCM). Dr. Amaral, Head of the Skin Cancer Clinical Trials Center at the University of Tübingen in Germany, will share results highlighting the power of the Merlin CP-GEP test (Clinicopathologic and Gene Expression Profile) in identifying high-risk melanoma patients who did not undergo sentinel lymph node biopsy (SLNB). The findings address a critical gap in current melanoma staging and point to CP-GEP’s potential in predicting relapse and survival outcomes.

Study Highlights and Results

The study evaluated 930 stage I/II cutaneous melanoma patients who had not received SLNB. Using the CP-GEP test, patients were categorized into two risk groups: 879 (94.5%) were classified as Low-Risk, while 51 (5.5%) were identified as High-Risk.

Outcomes in the Low-Risk group were particularly strong, with a 96% relapse-free survival (RFS) rate at 5 years and 94.5% at 10 years. In contrast, those in the High-Risk category were approximately 20 times more likely to experience recurrence. Their RFS was significantly lower—only 37.5% at both 5 and 10 years. These patients also showed a higher incidence of distant metastases and melanoma-specific deaths, emphasizing the test’s clinical value in identifying patients at greater risk of poor outcomes.

While SLNB remains a widely accepted standard for melanoma staging, it’s not always performed—especially in patients deemed low-risk by traditional measures. However, some of these patients still go on to experience recurrence. The CP-GEP test, which combines gene expression data with patient age and tumor thickness, offers a more refined method to stratify risk among those who do not receive SLNB, potentially guiding better treatment decisions.

Expert Perspectives

Dr. Amaral commented on the study’s significance: “These findings show the potential of the Merlin CP-GEP test to enhance how we assess risk in melanoma patients. For those who might otherwise not receive SLNB, CP-GEP offers a path toward more personalized care and potentially improved long-term outcomes.”

SkylineDx’s Chief Scientific Officer, Dr. Jvalini Dwarkasing, added: “The test’s ability to pinpoint high-risk patients—even without SLNB status—could open the door to new treatment opportunities. It’s possible that those identified as High-Risk might benefit from systemic therapies similar to those currently offered to SLNB-positive patients.”

SkylineDx continues to advance its mission of improving personalized cancer care through the development of cutting-edge molecular diagnostics like CP-GEP.

About the Merlin CP-GEP Test

The CP-GEP test is a non-invasive, clinically validated model that combines clinicopathologic data with gene expression profiling. It is the only commercially available GEP test that delivers a binary risk classification—High or Low—for melanoma metastasis. The model was developed in partnership with the Mayo Clinic and has been validated in multiple international studies. The Merlin test is currently available in the U.S. and Europe. More information is available at www.falconprogram.com and www.merlinmelanomatest.com.

Footnotes:

1. T. Amaral et.al. Identification of patients at high risk for relapse using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients (pts) with stage I/II melanoma who did not undergo sentinel lymph node biopsy. Abstract at WMC 2025: tuebingen-930-eado2025.pdf

2. T. Amaral, E. Chatziioannou, A. Nuebling, et al. Risk stratification using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients with clinical stage I/II melanoma who did not undergo sentinel lymph node biopsy. Eur J Cancer (2025).