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SkylineDx Unveils the Merlin Assay at ASCO 2025

At the recent 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, SkylineDx showcased its groundbreaking Merlin Assay (CP-GEP), demonstrating its potential to accurately predict recurrence risk in patients with head and neck melanoma, even without the need for a sentinel lymph node biopsy (SLNB). This significant advancement in molecular diagnostics has drawn the attention of medical professionals looking for reliable non-invasive methods for managing melanoma recovery.

Understanding the Merlin Assay

The Merlin Assay is a genomic test designed to guide treatment decisions in early-stage melanoma patients, using gene expression profiling to stratify individuals according to their risk of cancer recurrence. Dr. Teresa Amaral, the Principal Investigator, explained that the assay offers a revolutionary alternative to SLNB, which often poses logistical challenges for patients with head and neck melanoma due to the complex anatomy of the lymphatic system in this region. As such, the Merlin Assay was validated through a study involving 206 patients with head and neck cancer, a significant number of whom had the lentigo maligna subtype prevalent in older populations.

Key Findings from the Study

The results from the ASCO presentation were striking, revealing considerable disparities in outcomes between low- and high-risk patient groups identified by the Merlin Assay:

• - 10-year relapse-free survival (RFS) was 87.9% for Low-Risk patients versus 45.8% for High-Risk individuals, showcasing a significant hazard ratio of 7.35 (p<0.001).
• - 10-year distant metastasis-free survival (DMFS) demonstrated 94.7% for Low-Risk patients compared to only 75.8% for their High-Risk counterparts (HR 6.28; p<0.001).
• - 10-year melanoma-specific survival (MSS) statistics stood at 96.4% for Low-Risk patients against 74.0% for High-Risk, indicating a drastic difference in outcomes (HR 10.22; p<0.01).

These results suggest that the Merlin Assay can significantly enhance patient risk stratification and treatment planning, providing a reliable alternative that could spare many patients from invasive surgical procedures.

Implications for Clinical Practice

The implications of these findings underline the clinical utility of the Merlin Assay in regions where lymphatic mapping presents challenges. Dr. Jvalini Dwarkasing, SkylineDx’s Chief Scientific Officer, emphasized the assay’s importance for managing the approximately 20% of early-stage melanoma cases occurring in the head and neck area, a complex domain where traditional methods may prove inefficient due to patient health concerns and anatomical difficulties.

Clinical Integration

The Merlin Assay integrates critical clinical and pathological variables with gene expression profiling, marking it as the only commercially available GEP test that provides a binary risk stratification system. Patients are categorized as either High-Risk or Low-Risk for metastasis, ensuring that they receive tailored surgical interventions in line with established cancer treatment guidelines. Developed collaboratively with Mayo Clinic, the CP-GEP model stands validated through multiple international studies, making it a vital resource for clinicians worldwide.

Conclusion

As SkylineDx strives to bridge the gap between medical research and clinical application, the launch of the Merlin Assay represents not just a technological milestone; it signifies a transformative shift in the approach to melanoma treatment. With its potential to optimize patient outcomes through precise risk assessment, this assay could play a crucial role in personalizing patient care for those affected by melanoma. To explore more about the Merlin Assay, visit Merlin Melanoma Test.

SkylineDx remains committed to extending access to this innovative diagnostic tool, aiming to enhance the quality of care for melanoma patients globally.