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Gene-Based Test May Help Personalize Treatment for Early-Stage Melanoma

February 10, 2026 discoverhiddenusacom Health

A new gene-based assay may offer a more precise way to assess the risk of melanoma spreading, potentially reducing the need for surgery in some early-stage patients. Results from a recent clinical trial, published in JAMA Surgery, suggest the test can help physicians better understand a tumor’s potential for aggressive behavior.

Understanding the Current Approach

Currently, melanoma staging relies on the tumor, node, metastasis (TNM) system. This system classifies tumors based on their size, whether cancer has spread to lymph nodes and if it has reached distant organs. While useful, the TNM system doesn’t always fully predict how a tumor will behave. Some patients with stage I melanoma still experience recurrence or spread to lymph nodes, even when traditional staging methods don’t indicate a high risk.

A New Tool for Risk Assessment

The trial evaluated the Merlin test, a gene expression assay that analyzes tumor tissue from a patient’s initial biopsy. The assay combines genetic information with established clinical features to create a personalized risk estimate for lymph node involvement. Here’s the first large, prospective clinical trial to determine if this type of approach can improve risk prediction for early-stage melanoma.

Did You Know? Unlike previous studies, this trial was designed to follow patients forward in time, rather than looking back at past data.

Georgia Beasley, MD, a surgical oncologist at the Duke Cancer Institute (DCI) and co-investigator on the trial, explained that relying solely on conventional staging may cause physicians to miss “bad actors”—tumors with a higher potential for spread. She noted that other cancers, like breast cancer, have already begun incorporating gene-based tools for risk prediction, while melanoma has been slower to adopt this approach.

Potential Benefits for Patients

One of the most immediate benefits of the Merlin test is its potential to guide surgical decisions, specifically regarding sentinel lymph node biopsy. This procedure, which involves removing and examining lymph nodes to check for cancer, requires anesthesia and carries some risk of complications. The test could be particularly valuable for older patients or those with other medical conditions.

Expert Insight: The ability to potentially avoid unnecessary surgery and its associated risks represents a significant step toward more personalized and less invasive melanoma care.

The test may also reduce uncertainty for both patients and physicians. While patients often want to pursue all possible interventions, a reliable risk estimate could help facilitate informed decisions about less aggressive treatment options when appropriate.

What’s Next?

The Merlin assay is now commercially available for physicians to order for selected patients. Researchers are already working to streamline the process, with a focus on digitizing how tumor samples are handled. Currently, tumor samples are sent as glass pathology slides, which can delay results. A digital platform could potentially deliver results faster, allowing for more timely treatment decisions.

Frequently Asked Questions

What is the Merlin test?

The Merlin test is a gene expression assay that analyzes tumor tissue from a melanoma biopsy. It combines genetic information with clinical features to estimate a patient’s risk of lymph node spread.

Who might benefit from this test?

Patients diagnosed with early-stage melanoma may benefit from this test, particularly those for whom the decision about whether to undergo sentinel lymph node biopsy is uncertain. It may be especially relevant for older patients or those with other medical conditions.

Is this test widely available?

Following the publication of the trial results, the Merlin assay is now commercially available and can be ordered by physicians, including those at Duke.

How might advancements in technology further improve the use of these types of assays in cancer care?

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