SkylineDx, a leading diagnostics innovator specializing in molecular diagnostics for oncology, inflammatory, and infectious diseases, has announced significant findings from a Danish validation study recently published in the Journal of Surgical Oncology. This study confirms that SkylineDx’s Merlin Assay, also known as CP-GEP, can accurately identify cutaneous melanoma patients, particularly those in the pT1 and pT2 stages, who are at low risk of developing nodal metastasis. This identification could potentially allow these patients to avoid undergoing Sentinel Lymph Node Biopsy (SLNB), a commonly performed but invasive surgical procedure. The Merlin Assay serves as a genomic tool designed to support clinical decision-making in early-stage melanoma treatment.
Conducted as an independent, blinded multicenter study, researchers examined primary cutaneous melanoma tissue from a cohort of 536 newly diagnosed melanoma patients ranging from pT1 to pT3 stages. These patients had previously undergone SLNB procedures between 2010 and 2015. Using the CP-GEP test, the study compared Merlin’s predictive outcomes against the patients’ actual sentinel lymph node status and the results from an internationally accepted nomogram used for assessing SLN metastasis risk. The data highlighted that the Merlin test could have helped avoid SLNB surgeries for a significant percentage of patients without compromising diagnostic accuracy. With over 41% of the larger group of pT1-pT3 patients classified as low-risk, patients in the pT1 subgroup in particular demonstrated a possible SLNB reduction rate of over 70%, indicating that a significant portion might have safely avoided SLNB operation.
SkylineDx’s Merlin Assay demonstrated superior performance compared to traditional risk assessment tools, showing notably higher SLNB reduction rates while maintaining a high negative predictive value. This supports the clinical value of incorporating genomic testing into surgical decision-making processes. According to researchers, including Dr. Marie B.-M. Weitemeyer from Copenhagen University Hospital, these findings reinforce Merlin’s role as a validated and effective tool for refining patient selection for SLNB and reducing unnecessary surgical interventions. Jvalini Dwarkasing, PhD, Chief Scientific Officer of SkylineDx, further emphasized that Merlin consistently delivers higher efficiency in SLNB reduction across various patient cohorts when compared with standard nomograms.
Currently, SLNB remains the gold standard for staging in primary melanoma cases, especially for patients with pT1b stage and higher. However, the majority of these patients do not present with nodal metastasis, meaning they undergo invasive surgery unnecessarily. This not only places them at surgical risk but also adds strain to healthcare systems. The Merlin Assay offers a sophisticated way to enhance surgical decision-making and lessen patient burden by providing doctors with the only gene expression profile-based predictive tool designed especially to evaluate nodal metastatic risk in melanoma patients.
SkylineDx’s CP-GEP model integrates both clinicopathologic variables and gene expression profiling into a single predictive algorithm, providing clear risk stratification to guide clinical decisions. Developed in collaboration with Mayo Clinic, the Merlin Assay stands as the latest GEP test to reach commercial availability, following successful clinical validation in multiple international studies. It is currently available across both the US and Europe, with SkylineDx working alongside diagnostic partners globally to broaden patient access to this transformative technology.
Headquartered in Rotterdam, the Netherlands, and supported by its US operations and laboratory in San Diego, SkylineDx continues its mission of translating complex genomic data into practical diagnostic solutions that support personalized treatment strategies and improved patient outcomes.
