In a groundbreaking advancement for melanoma patients and the broader medical community, two recent studies have illuminated the potential of a pioneering approach—the Merlin test (CP-GEP model)—in identifying early-stage cutaneous melanoma patients at elevated risk of disease relapse. These findings, set to be discussed at the European Association for Dermato-Oncology congress from April 4-6, 2024, are poised to revolutionize patient management and treatment stratification in the field of oncology.

The first study, spearheaded by Danish researchers, delved into the outcomes of over 400 patients who had undergone a sentinel lymph node biopsy (SLNB) between 2010 and 2015, all showing no signs of metastasis. By applying the CP-GEP model to archived tumor specimens and correlating the results with 5 years of clinical data, researchers discovered a significant capability of this model to divide node-negative patients into low- and high-risk categories for disease progression. Specifically, the study found that within five years following their diagnosis, 17.2% of patients classified as high-risk experienced a recurrence, versus 8% in the low-risk group.

While SLNB remains a critical procedure for the clinical staging of cutaneous melanoma, it’s not universally applicable. Challenges particularly arise in biopsies concerning the head and neck region due to the complex network of nerves and lymphatic drainage, posing substantial risks. Addressing this gap, the second study led by Dr. Amaral of the University of Tuebingen, Germany, focused on a subset of melanoma patients with primary tumors in the head and neck area who did not undergo SLNB. Remarkably, the CP-GEP model succeeded in identifying high-risk patients within this independent dataset, underscoring its utility in offering a less invasive yet effective method for risk stratification.

The CP-GEP model combines clinicopathologic (CP) variables with gene expression profiling (GEP), heralding a new era in the non-invasive prediction of cutaneous melanoma patient outcomes. Developed through the collaborative efforts of Mayo Clinic and SkylineDx BV, this model has achieved clinical validation in multiple studies, affirming its promise for identifying patients at low-risk for nodal metastasis who might bypass the SLNB procedure altogether.

SkylineDx, the biotechnological company behind the Merlin test (also known as CP-GEP), is at the forefront of transforming these scientific insights into practical diagnostic solutions. With operations in Rotterdam, the Netherlands, and a CAP/CLIA certified laboratory in San Diego, California, the company straddles a crucial intersection between academic research and commercial diagnostics, striving to enhance patient care through precision medicine.

In the U.S., the implementation of CP-GEP has materialized under various proprietary versions like Tempus’s Tempus Merlin test and Quest Diagnostics’ MelaNodal Predict™. These developments reflect a wider industry movement towards more personalized, less invasive oncology diagnostics, contributing significantly to the quality and specificity of care provided to melanoma patients.

As the Merlin test gains traction and visibility across Europe and the United States, its potential to refine treatment approaches and improve surveillance strategies for early-stage melanoma stands as a testament to the progressive convergence of genomics and patient care. The implication of these studies, promising though they are, represents just the beginning of a broader paradigm shift in how melanoma, and potentially other cancers, are diagnosed and managed in the future.