SkylineDx's Merlin Melanoma Assay shows its ability to reduce SLNB by over 40% in a Danish Multicenter Validation Study

• In the independent blinded validation study, Merlin accurately identifies melanoma patients at low risk of metastatic disease, including sentinel lymph node metastasis 
• The potential SLNB surgery reduction rate is above 70% in pT1 patients

ROTTERDAM, Netherlands and SAN DIEGO, July 22, 2025 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory and infectious diseases, today announced detailed results from a Danish validation study, published in the Journal of Surgical Oncology. The study demonstrates that SkylineDx's Merlin Assay (CP-GEP) can identify cutaneous melanoma patients, in particular pT1 and pT2 patients, that have a low risk for nodal metastasis and therefore may forgo Sentinel lymph node biopsy (SLNB) surgery. Merlin is a genomic test to guide treatment decisions in early-stage melanoma.

In the independent blinded multicenter study, primary cutaneous melanoma tissue from a cohort of 536 newly diagnosed pT1-pT3 melanoma patients who had undergone SLNB between 2010 and 2015 was collected and analyzed with CP-GEP. Merlin's outcome labels were compared to patients' sentinel lymph node status and a nomogram that is widely used on an international basis for SLN metastasis risk.

Key findings of the study include:

• The potential SLNB reduction rate was highest for the pT1-subgroup at 72.7% (NPV 94.5%) In pT1-pT3 melanoma, 41% of patients were classified as CP-GEP Low-Risk and could have forgone SLNB surgery, which is in line with previous validation studies.
• Comparison with an internationally recognized nomogram showed that CP-GEP would result in a notably larger SLNB reduction rate compared to the internationally recognized nomogram (44.2% vs. 7.8%) particularly for T1- T3 patients.

"The Merlin test is a promising and well-validated non-invasive tool for refining SLNB selection, with consistent findings across several independent cohorts," said First Author Dr. Marie B.-M. Weitemeyer from Copenhagen University Hospital-Herlev and Gentofte. "In our Danish cohort, Merlin demonstrated the potential to reduce unnecessary SLNB procedures by more than 40%."

"Merlin performance is consistent with previous study cohorts," said SkylineDx Chief Scientific Officer, Jvalini Dwarkasing, PhD. "Compared to the internationally recognized nomogram, CP-GEP demonstrated a significantly higher SLNB reduction rate while maintaining a high NPV, underscoring its potential for greater clinical benefit."

SLNB is the gold standard in staging primary melanoma patients. According to current guidelines, patients with pT1b melanoma and higher may be eligible for SLNB surgery. However, approximately 85% of these patients will not show SLN metastasis while undergoing this invasive procedure, under general anesthesia, with the risk of potential surgical complications. Also, SLNB poses a substantial burden on healthcare resources. Therefore, tools are warranted beyond clinical guidelines to stratify patients based on their risk of nodal metastasis. SkylineDx's CP-GEP is currently the only GEP-based prediction tool specifically developed to identify melanoma patients at low risk of SLN metastasis. 

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:

Marie B.-M. Weitemeyer, Neel M. Helvind, Siri Klausen et al.,) Validation of a clinicopathologic and gene expression model for predicting sentinel node metastasis in melanoma: A multicenter Danish cohort study. JSO 2025, Link to the publication.

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