SkylineDx Announces All Patients Enrolled in Landmark Study MERLIN_001, Advancing Melanoma Diagnostics
Source: PR Newswire, July 2024
ROTTERDAM, Netherlands and SAN DIEGO, July 9, 2024 /PRNewswire/ — SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, proudly announces the successful enrollment of the MERLIN_001 study. This study is the largest independent multicenter prospective investigation to date into the role of Gene Expression Profiling (GEP) testing in melanoma care. This milestone marks the conclusion of enrollment with the final patient now included in this groundbreaking prospective registry study [1].
MERLIN_001 was designed with the aim of prospectively validating the Merlin Assay – a clinicopathologic GEP model – in an independent multicenter cohort of clinically node negative primary cutaneous melanoma patients, who are undergoing lymphatic mapping and sentinel lymph node biopsy (SLNB) per current clinical guidelines. The primary objective of this study is to evaluate the ability of the Merlin Assay to predict risk of sentinel node metastasis in melanoma patients who are candidates for SLNB. Spanning 9 centers across the US, the study enrolled 1,640 eligible patients over the past 3 years, reflecting a comprehensive real-world cross-section of the melanoma patients referred for SLNB.
Independent prospective validation is crucial for GEP testing to show its clinical value and establish their cost-effectiveness [2]. Previous prospective data from the Netherlands affirmed the performance metrics published from multiple independent international retrospective cohorts. All of these publications conclude that the Merlin Assay can accurately identify patients at low risk for nodal metastasis.