SkylineDx Highlights Merlin Assay's Power to Predict Recurrence Risk of Head and Neck Melanoma Without Sentinel lymph node Biopsy at ASCO 2025

• Merlin accurately identifies patients with head and neck melanoma at high risk of recurrence, even without sentinel lymph node biopsy
• Study reveals that patients with CP-GEP High-Risk are over seven times more likely to have a recurrence and 10 times more likely to die from melanoma, compared to patients with CP-GEP Low-Risk

ROTTERDAM, the Netherlands and SAN DIEGO, June 2, 2025 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory and infectious diseases, presented a new independent study at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating that its Merlin Assay (CP-GEP), a genomic test to guide treatment decisions in early-stage melanoma, can reliably identify patients with head and neck (H&N) melanoma at high risk for recurrence-even in the absence of sentinel lymph node biopsy (SLNB) [1].

SLNB may be challenging in patients with H&N melanoma due to the regional course of cranial nerves and lymphatic drainage, so the aim of the study was to validate CP-GEP's ability to stratify these patients for their risk of recurrence. The study analyzed a subgroup of 206 patients with H&N melanoma, including a large proportion with lentigo maligna, a subtype common in older adults, from a previously published cohort of 930 stage I/II melanoma patients who did not undergo SLNB [2]. Using CP-GEP, researchers stratified patients into low- and high-risk categories based on tumor biology. Results showed a dramatic difference in outcomes:

• 10-year relapse-free survival (RFS) was 87.9% in CP-GEP Low-Risk patients compared to 45.8% in the High-Risk group (Hazard Ratio (HR) 7.35; p<0.001).
• 10-year distant metastasis-free survival (DMFS) was 94.7% for CP-GEP Low-Risk and 75.8% for High-Risk patients (HR 6.28; p<0.001).
• 10-year melanoma-specific survival (MSS) was 96.4% for Low-Risk vs. 74.0% for High-Risk (HR 10.22; p<0.01).

"The Merlin Assay is a major advancement in personalized care for patients with head and neck melanoma," said Principal Investigator, Teresa Amaral MD, PhD "SLNB can be technically challenging in the head and neck region. Merlin offers a powerful alternative for clinicians to make informed decisions without subjecting patients to unnecessary and potentially complicated surgical procedures."

"The findings build on prior data and highlight Merlin's growing clinical utility in a region of the body where lymphatic mapping is less reliable and patient frailty often limits invasive procedures", said Chief Scientific Officer at SkylineDx, Dr. Jvalini Dwarkasing. "For the more than 20% of early-stage melanoma cases in the head and neck area, these results support that Merlin helps fill a critical gap in risk stratification and care planning."

About the Merlin Assay (CP-GEP)

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 and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com.

About SkylineDx

SkylineDx is a biotechnology company focused on research and development of molecular diagnostics in oncology inflammatory, and infectious diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam, the Netherlands, complemented by a US base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes:

1. T. Amaral, E. Chatziioannou A. Neubling, et al. 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. Link to poster.
   
   
2. T. Amaral, E. Chatziioannou, A. Nuebling, et al. 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. Eur J Cancer (2025).

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