SkylineDx has completed patient enrolment for the landmark MERLIN_001 study of the Merlin Assay, which is set to advance melanoma diagnostics.

The study will prospectively validate the Merlin Assay, a clinicopathologic (CP) Gene Expression Profiling (GEP) test, in predicting the risk of sentinel node metastasis in melanoma patients.

MERLIN_001 is claimed to be the largest independent multicentre prospective investigation into the GEP testing role in melanoma care till date.

The study aims to validate the Merlin Assay in a cohort of clinically node-negative primary cutaneous melanoma patients undergoing lymphatic mapping and sentinel lymph node biopsy (SLNB) according to current clinical guidelines.

The CP-GEP model, developed by Mayo Clinic and SkylineDx, will assess the metastatic potential in cutaneous melanoma patients.

This non-invasive prediction model could potentially allow certain patients at low risk for nodal metastasis to safely forgo the SLNB procedure.

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The MERLIN_001 Study involved nine centres across the US and has enrolled 1,640 patients over the past three years.

This reflects a diverse cross-section of the melanoma population referred for SLNB, providing a comprehensive real-world perspective.

SkylineDx CEO Dharminder Chahal said: “The successful completion of patient enrolment 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.”

Previous prospective outcomes from the Netherlands have supported the performance metrics of the Merlin Assay, which has been shown to accurately identify patients at low nodal metastasis risk.

SkylineDx will analyse the data collected from the MERLIN_001 study and share the results with the medical community.

The insights gained are expected to enhance the precision and personalisation of melanoma care, with potential benefits for patients worldwide.