SkylineDx Announces All Patients Enrolled in Landmark Study MERLIN_001, Advancing Melanoma Diagnostics

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.

Dharminder Chahal, CEO of SkylineDx, commented: "The successful completion of patient enrollment in the MERLIN_001 study represents a monumental achievement in our melanoma research efforts. We are immensely grateful to all the patients who participated and to our dedicated team of researchers and collaborators. This study underscores our commitment to advancing personalized medicine and improving outcomes for melanoma patients worldwide."

Vernon K. Sondak, MD, Chair of the Department of Cutaneous Oncology at Moffitt Cancer Center in Tampa, FL, and Principal Investigator of the MERLIN_001 study, added: "The importance of this large multicenter investigation cannot be overstated. The collaboration among leading institutions across the country has been instrumental in driving the success of this study. The diverse patient population and the rigorous methodology employed have provided a robust dataset that will significantly advance our understanding of the potential role of gene expression profiling in melanoma, and the results will enhance patient care."

SkylineDx extends heartfelt thanks to all the patients who participated in the MERLIN_001 study. Their confidence and willingness to contribute to this innovative research are invaluable. We also thank our collaborators, healthcare professionals, and research teams for their unwavering support and dedication.

As we move forward, SkylineDx remains committed to analyzing the data collected and sharing comprehensive results with the medical community. The insights gained from the MERLIN_001 study will pave the way for more precise and personalized melanoma care, ultimately benefiting patients globally.

About CP-GEP

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to assess metastatic potential in cutaneous melanoma patients, thus identifying those at low risk for nodal metastasis who may potentially safely forgo the sentinel lymph node biopsy (SLNB) procedure. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies. More information (including references) may be obtained at www.falconprogram.com. The test has been launched in the United States and Europe as the Merlin Assay. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase access. In the United States, Tempus is commercializing  Tempus Merlin test.

Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict^™.

About SkylineDx

SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes:

1. Hieken et al. MERLIN_001: A prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of patients with SN-negative melanoma. https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS9606, https://aacrjournals.org/cancerres/article/83/8_Supplement/CT053/725324/Abstract-CT053-Merlin-001-a-prospective-registry
2. Grossman et al. Prognostic Gene Expression Profiling in Cutaneous Melanoma https://jamanetwork.com/journals/jamadermatology/article-abstract/2768743