Merlin™ Assay (CE-IVD)
The Merlin™ Assay incorporates clinicopathologic variables (age and Breslow thickness) to the gene expression profiling component to accurately predict the risk of nodal metastasis in primary cutaneous melanoma patients. Low-risk patients may forgo the sentinel lymph node biopsy (SLNB). The non-invasive Merlin™ Assay does not require an additional procedure for the patient as it uses primary tumor tissue* that was collected for the melanoma diagnosis.
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SkylineDx & Biocartis partnering
*Check specimen requirements in section below
Specimen requirements:
- 5 x 10 µm formalin fixed and paraffin embedded (FFPE) tissue of primary cutaneous melanoma biopsy
- No macrodissection needed
Supports your decision-making
The Merlin™ Assay may help you optimize the clinical management of each patient. Validation studies in the United States and Europe confirm that the assay accurately stratifies patients who have a low risk of nodal metastasis, reducing the number of unnecessary SLNB surgeries by ~40%1 .
2 Moody JA, Botham SJ, Dahill KE, Wallace DL, Hardwicke JT. Complications following completion lymphadenectomy versus therapeutic lymphadenectomy for melanoma. A systematic review of the literature. EJSO. 2017;43(2017):1760-1767.
- 1Bellomo D, Arias-Mejias S, Ramana C, et al. A model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precis Oncol. 2020:DOI 10.1200/PO.19.00206.
The biology behind the Merlin™ Assay
The Merlin™ Assay uses the CP-GEP model, an algorithm developed by logistic regression modelling. The combination of clinicopathologic factors – patient’s age and Breslow thickness – with the gene expression profiling component of 8 specific genes involved in cancer metastasis and melanosome biogenesis, will allow you to better understand your patient’s risk and may optimize a personalized treatment plan.
