SKYLINEDX ANNOUNCES NEW STUDY DEMONSTRATING ENHANCED RISK STRATIFICATION FOR SENTINEL LYMPH NODE BIOPSY IN HEAD AND NECK MELANOMA USING THE ADVANCED MERLIN CP-GEP TEST

ROTTERDAM, Netherlands and SAN DIEGO, March 12, 2025 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology and, inflammatory and infectious diseases, proudly announces the publication of a groundbreaking study titled "Enhanced Risk Stratification for Sentinel Lymph Node Biopsy in Head and Neck Melanoma Using the Merlin Assay (CP-GEP)." [1] This study, led by Ani Pazhava, MD, and colleagues from the Mayo Clinic and University Hospitals Cleveland Medical Center and SkylineDx, highlights the potential of the Merlin test to refine clinical decision-making in head and neck melanoma patients.

Sentinel lymph node biopsy (SLNB) is the gold standard for staging cutaneous melanoma. However, melanomas in the head and neck region pose unique challenges due to complex lymphatic drainage and vital anatomical structures, often leading to higher false-negative sentinel lymph node biopsy rates and higher recurrence rates compared to other locations on the body. The Merlin CP-GEP test is the only GEP test that combines clinicopathologic factors with gene expression profiling into a single algorithm to predict the risk of metastases beyond the primary melanoma. If the Merlin test result is "Low Risk" then it offers head and neck melanoma patients a non-invasive alternative for surgery as these patients may forgo SLNB due to their low risk of having nodal metastasis. Additionally, these head and neck melanoma patients that Merlin has classified as low risk for metastatic disease are less likely to experience a recurrence and have a favorable long-term survival compared to patients who have a Merlin test "High Risk" result. The study analyzed 250 patients with stage I-III head and neck melanoma diagnosed between 2004 and 2021. All of the patients in the study underwent a sentinel lymph node biopsy, which is essential for assessing the predictive power and accuracy of the Merlin test. The Merlin test classified 40.8% of patients as Low Risk for nodal metastases, predicting a corresponding 40.8% reduction in SLNB procedures, with a high negative predictive value (NPV) of 98%. This means that 98% of the patients with a Merlin test "Low Risk" result actually did have a negative sentinel lymph node biopsy. Among the SLNB-negative patients, the test identified 100 individuals as "Low Risk" with a five-year melanoma-specific survival (MSS) of 95.3%. In the subgroup T1-T2 patients, the test achieved a 56.3% SLNB reduction rate with an excellent NPV of 98.9%.

"This study underscores the transformative potential and the power of the Merlin test in accurately predicting the metastatic risk associated with complex head and neck melanomas," said Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx. "By enhancing risk stratification, we can improve patient outcomes, optimize surgical procedures and utilization of healthcare resources. This advancement represents a significant step towards personalized melanoma care."

SkylineDx is dedicated to improving patient outcomes through innovative diagnostic solutions. Our test provides actionable insights for personalized treatment strategies, enhancing the precision of healthcare worldwide.

About the Advanced CP-GEP (Merlin 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 generation 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.

About SkylineDx
SkylineDx is a biotechnology company focused on research & 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 U.S. 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. A. Pazhava et. al. Enhanced Risk Stratification for Sentinel Lymph Node Biopsy in Head and Neck Melanoma Using the Merlin Assay (CP–GEP) Enhanced Risk Stratification for Sentinel Lymph Node Biopsy in Head and Neck Melanoma Using the Merlin Assay (CP-GEP) | Annals of Surgical Oncology