Genetic Test a Potential Alternative to Sentinel Lymph Node Biopsy

Published:  
06/05/2025
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There may be a non-invasive option available for patients with head and neck melanoma who cannot easily receive a sentinel lymph node biopsy. Data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago suggested a new test could guide treatment decisions without requiring patients to undergo unnecessary surgical procedures.

The test is called the Merlin Assay, a type of test called CP-GEP—or, clinicopathological gene expression profiling—and it may help a subset of patients diagnosed with melanoma. It uses a non-invasive prediction model that combines patient tumor genetics with the patient’s age and clinical features of the melanoma to assess whether a patient has a low or high risk for melanoma recurrence.

A test like this offers a welcome alternative to surgery to the group of patients with melanoma on their head and neck because it can be challenging to perform a sentinel lymph node biopsy in the neck area.

Among 930 patients with early-stage melanoma on the head and neck, Merlin was able to correctly identify 51 patients at high risk for recurrence. The result occurred despite the group not having undergone a sentinel lymph node biopsy, which means it could replace the surgical procedure.

The assay can categorize patients based on a high or low risk of melanoma recurrence. For example, a high-risk Merlin CP-GEP result indicates an increased risk of recurrence of at least seven times greater than average. Similarly, if the Merlin Assay CP-GEP categorized a patient with high-risk disease, then they are 10 times more likely to succumb to melanoma in comparison to those in the low-risk disease category. Patients designated low risk have excellent long-term survival rates.

A test like this offers a welcome alternative to surgery to the group of patients with melanoma on their head and neck because it can be challenging to perform a sentinel lymph node biopsy in the neck area. For example, lymphatic drainage issues and potential scarring can be difficult in this area of the body, and surgery on frail patients is always challenging. The current study tested a group of patients with Stage I and II melanoma.

It is a commercially available test for patients with melanoma. It was developed in collaboration between Skyline DX, a biotech company, and the Mayo Clinic.

This article summarized data from a poster by T. Amaral, E. Chatziioannou A. Neubling, et al. titled, “Identification of patients at high risk for relapse by Merlin Assay (CP-GEP) in an independent cohort of melanoma patients that did not undergo sentinel lymph node biopsy: an H&N subgroup analysis,” P9567 at ASCO Annual Meeting 2025. It also used the press release, “SkylineDx Highlights Merlin Assay’s Power to Predict Recurrence Risk of Head and Neck Melanoma Without Sentinel lymph node Biopsy at ASCO 2025,” and the publication, “Risk stratification using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients with clinical stage I/II melanoma who did not undergo sentinel lymph node biopsy,” in the European Journal of Cancer in May 2025.