New Melanoma Metastasis Risk Prediction Tool Debuts

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Quest Diagnostics on Tuesday announced a new tool available to dermatologists for making treatment decisions for patients with melanoma.

The gene expression test, MelaNodal Predict, is based on technology developed by the oncology biotechnology company SkylineDx and researchers at Mayo Clinic.¹

The test uses clinicopathologic features (biopsy findings and patient age) along with gene expression profiling (together called CP-GEP) to help providers identify patients with a low or high risk of nodal metastasis.²

This information allows dermatologists to determine which patients can safely avoid a sentinel lymph node biopsy, according to the company.

Michael E. Egger, MD, MPH, an associate professor at the University of Louisville in the Hiram C. Polk, Jr, MD, Department of Surgery/Division of Surgical Oncology, is currently working with others to evaluate the CP-GEP test in a prospective study (MERLIN_001). “The findings from the study may help us decide who can safely forego a sentinel lymph node biopsy or perhaps even develop a tailored, patient-specific surveillance plan based on their risk of recurrence,” he told Dermatology Times.

“The CP-GEP test is performed from the tissue already sampled in the biopsy specimen obtained from the dermatologist’s office,” he said. “Several thin slices off the tissue block are sent to the lab to be tested for specific gene activity. The information from that analysis is combined with clinical and pathologic features from the patient in an algorithm that results in a ‘high’ or ‘low’ risk classification of the melanoma. The results of the test can help the surgeon determine whether a sentinel lymph node biopsy is needed, or if the patient has a high risk of recurrence after surgery.”

All studies of the instrument’s algorithm have reported minimal follow up after 5 years,² according to the company, and recent data from 6 United States institutions show that patients whom the algorithm classified as “low risk” have a survival rate of more than 90 percent.³

Quest Diagnostics noted in its Tuesday press release that the MelaNodal Predict test is now available for purchase by dermatologists.

Kristie Dolan, senior vice president and general manager of oncology at Quest Diagnostics, told Dermatology Times, “Dermatologists and dermatopathologists have to balance the benefits of sentinel lymph node biopsy with the potential harms in low-risk patients. MelaNodal Predict will help provide insights these providers can use to inform their patients' treatment plans.”

References

1. Quest Diagnostics. Quest diagnostics debuts MelaNodal Predict™ test, personalizing melanoma risk prediction to help patients forgo invasive surgery. News release. February 13, 2024. Accessed February 15, 2024. https://newsroom.questdiagnostics.com/2024-02-13-Quest-Diagnostics-Debuts-MelaNodal-Predict-TM-Test,-Personalizing-Melanoma-Risk-Prediction-to-Help-Patients-Forgo-Invasive-Surgery

2. Amaral T, Sinnberg T, Chatziioannou E, et al. Identification of stage I/II melanoma patients at high risk for recurrence using a model combining clinicopathologic factors with gene expression profiling (CP-GEP). Eur J Cancer. 2023;182:155-162. doi:10.1016/j.ejca.2022.12.021

3. Skyline Dx. Multicenter US study reveals CP-GEP’s profound impact on stratifying melanoma patients for long-term survival. https://c212.net/c/link/?t=0&l=en&o=4089971-1&h=1205978979&u=https%3A%2F%2Fwww.skylinedx.com%2Fnews-news%2Fsmr-poster&a=Multicenter+US+Study+Reveals+CP-GEP%27s+Profound+Impact+on+Stratifying+Melanoma+Patients+for+Long-Term+Survival+-+SkylineDx