On April 4, 2025 SkylineDx, an innovative diagnostics company specializing in molecular diagnostics for oncology, inflammatory, and infectious diseases, reported that Dr. Teresa Amaral, MD, PhD, Head of Skin Cancer Clinical Trials Center, University of Tübingen, Germany, will present groundbreaking new data at the 2025 World Congress of Melanoma (WCM) (Press release, SkylineDx, APR 4, 2025, View Source [SID1234651807]). The presentation will highlight the Merlin CP-GEP (Clinicopathologic and Gene Expression Profile) test’s ability to identify high-risk melanoma patients who did not undergo sentinel lymph node biopsy (SLNB), a critical gap in current melanoma staging methods – showing CP-GEP’s potential in predicting relapse and other long-term survival outcomes [1-2].

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Key Findings from the Study:

Merlin CP-GEP test successfully stratified 930 stage I/II melanoma patients: 879 (94.5%) were Merlin Low-Risk and 51 (5.5%) were Merlin High-Risk.
Patients identified as Low-Risk showed an impressive 5-year and 10-year relapse-free survival (RFS) rate of 96% and 94.5% respectively.
Patients in the Merlin (CP-GEP) High-Risk group were around 20 times more likely to experience a recurrence, compared to the Merlin Low-Risk group. Their 5-year and 10-year RFS was 37.5% for both endpoints. Additionally, High-Risk patients showed significantly increased rates of distant metastasis and melanoma-specific death, reinforcing the clinical value of CP-GEP in identifying patients at risk for recurrence.
While SLNB remains the standard for melanoma staging, many patients classified as low-risk based on traditional methods still experience relapse or even death. The CP-GEP model, which combines gene expression data with clinical factors age and tumor thickness, effectively identified two distinct risk groups among patients who did not undergo SLNB.

Dr. Teresa Amaral shared her thoughts on the study: "The results of this study highlight the potential of the Merlin CP-GEP test to redefine risk assessment for melanoma patients. By identifying high-risk individuals who may not have undergone SLNB, we can better personalize treatment decisions, ultimately improving long-term outcomes for patients."

Dr. Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx, commented, "These results highlight the power of CP-GEP in helping clinicians identify high-risk patients, even in the absence of SLNB status. Additional research is needed but potentially the Merlin High-Risk patients could benefit from systemic therapy to overcome their risk of recurrence, as their RFS is similar to that of patients who are currently eligible for immunotherapy."

SkylineDx remains committed to advancing innovative molecular diagnostic solutions that offer better insights and more personalized treatment options for melanoma patients, ultimately improving their chances for a better outcome.

About the advanced cutaneous melanoma GEP test (Merlin CP-GEP test)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx BV and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access.