SkylineDx's Merlin Assay stratifies Stage I/II cutaneous melanoma beyond SLNB for recurrence

ROTTERDAM, Netherlands, and SAN DIEGO, May 30, 2024 /PRNewswire/ -- SkylineDx announces the presentation of groundbreaking data at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. Dr. Teresa Amaral, MD, PhD, medical oncologist from the University of Tuebingen, Germany, will present findings on the identification of patients at high-risk for relapse in an independent cohort of 432 patients with stage I/II melanoma who did not undergo sentinel lymph node biopsy (SLNB) [1].

Cutaneous melanoma (CM) poses significant challenges as 40% [2] of melanoma-related deaths occur in patients diagnosed with early stages of the disease. Identifying high-risk tumors early enables physicians to take appropriate measures to detect potential relapses sooner with scheduling less intensive follow-up for patients with a low risk of recurrence. In the future, patients with high-risk tumors may also be considered for adjuvant therapeutic strategies. In this independent cohort analysis, formalin-fixed paraffin-embedded primary tumor samples from patients diagnosed with CM Stage I or II disease between 2000 and 2020 were analyzed. The CP-GEP model in the Merlin Assay, utilizing 8 genes combined with the patient's age and Breslow thickness, stratified patients into CP-GEP Low- or High-Risk categories for disease recurrence, independent of the SLNB.

CP-GEP Low-Risk patients demonstrated a melanoma specific survival of 99.7 at 5 years, while CP-GEP High-Risk patients had significantly heightened recurrence risk. The melanoma specific survival of the high-risk group was 42.2 at 5 years.

Dr. Teresa Amaral, the first author of this study, emphasized the importance of these findings: "This study highlights the crucial role of the CP-GEP model in identifying high-risk patients. By focusing on genetic and clinical factors, we can more accurately predict outcomes and tailor treatment strategies accordingly."

"This research showcases the Merlin Assay's transformative potential in personalized risk assessment beyond traditional nodal staging methods. By leveraging CP-GEP, we empower clinicians to identify patients with high-risk of relapse, enabling tailored treatment strategies and improved melanoma care,"- said Jvalini Dwarkasing, Chief Scientific Officer of SkylineDx.

The study's median 5-year follow-up provided robust prognostic insights into the Merlin Assay's performance in predicting relapse-free survival, distant metastasis-free survival, and melanoma-specific survival in patients that did not undergo an SLNB. This demonstrated the CP-GEP model's capability to stratify patients with CM patients independently of SLNB.

Dr. Amaral's presentation underscores CP-GEP's potential to enhance risk stratification beyond SLNB in patients with CM. By identifying high-risk individuals, the Merlin Assay informs personalized treatment strategies, optimizing patient outcomes, allowing for optimized surveillance schedules.

About CP-GEP

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to identify cutaneous melanoma patients at low risk for nodal metastasis who may forgo the sentinel lymph node biopsy (SLNB) procedure. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies. More information (including references) may be obtained at www.falconprogram.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 the access. In the United States, Tempus is commercializing Tempus Merlin test.

Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict™.

About SkylineDx

SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory 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. Amaral et al. Identification of patients at high risk for relapse using the Merlin Assay (CP-GEP) in an independent cohort of 432 patients with stage I/II melanoma who did not undergo sentinel lymph node biopsy ASCO_2024_Amaral.pdf (falconprogram.com)
2. Landow et al. Mortality burden and prognosis of thin melanomas overall and by subcategory of thickness, SEER registry data, 1992-2013 https://pubmed.ncbi.nlm.nih.gov/27887797/