SkylineDx: Independent Dutch Study Further Validates Merlin CP-GEP Test for Melanoma Prognosis

• The study assessed the overall diagnostic accuracy of the Merlin CP-GEP Test for predicting sentinel node metastases and recurrence risk
• The Merlin CP-GEP Test demonstrated strong predictive and prognostic performance, particularly for pT1b-pT2a melanoma patients, and thus should be considered added value to current standard of care practice

ROTTERDAM, the Netherlands, Jan. 8, 2026 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for dermatology, hematology, and infectious & inflammatory diseases, announced today an independent analysis in Annals of Surgical Oncology validating that its Merlin CP-GEP Test accurately identifies the risk of sentinel node metastases and recurrence in patients with clinical stage I and II melanoma.

Sentinel lymph node biopsy (SLNB) is the current gold standard procedure for patients with newly diagnosed melanoma; however, the majority of patients undergo SLNB with a negative result (75-85%). The data of this study supports the Merlin CP-GEP Test as a useful personalized decision-making tool for clinicians to identify which patients may forgo SNLB, a procedure that can come with certain risks and complications. In addition, the study shows good prognostic performance of the Merlin CP-GEP Test on long-term disease outcomes. The study used samples and clinical data from 252 patients with newly diagnosed clinical stage I and II melanoma between 2007 and 2015. The Merlin CP-GEP Test was successfully performed in 243 patients with a SLN positivity rate of 21.8%.
Findings include:

• The test successfully identified most patients who later experienced disease recurrence (40 of 47 cases - 85%), distant metastasis (32 of 35 cases - 91%), and melanoma specific deaths (19 of 20 cases - 95%), while the majority of relapses, 60% (28 of 47), were in SLNB negative patients.
• Five-year relapse-free survival rates were 89.6% for Merlin CP-GEP Low Risk patients vs. 76.8% for Merlin CP-GEP High Risk patients. Five-year distant metastasis-free survival was 95.6% and 81.3% respectively for Merlin CP-GEP Low and High Risk patients.
• Importantly, significant differences in melanoma specific survival between Merlin CP-GEP risk groups were shown: (Low Risk was 98.5% vs. 88.9% for High Risk), providing valuable information for patient discussions and treatment planning.
• The Merlin CP-GEP Test stratified melanomas into two distinct risk groups: High-Risk patients had almost a five-fold higher likelihood of SLN metastasis (28.0%) compared to Low-Risk patients (5.9%). Overall, 28% of patients were Low-Risk while 72% were High-Risk.

"This study demonstrates that precision medicine tools like the Merlin CP-GEP Test are transforming melanoma care." said Associated Professor, Chair of Melanoma Surgical Oncology at Melanoma Institute Australia and Principal Investigator Alexander C.J. van Akkooi, MD, PhD, FRACS. "Clearly CP-GEP could be both a non-invasive alternative, as well as a cost-effective substitute to surgical SLNB, which requires surgery, imaging, management of surgical complications and more. When we can confidently predict which patients are unlikely to have nodal metastasis, while maintaining excellent survival outcomes, we can deliver truly personalized care"

These results align with additional studies published earlier in Critical Reviews of Oncology/Hematology, Journal of Surgical Oncology, European Journal of Cancer and JAMA Surgery, further demonstrating the predictive and prognostic value of the Merlin CP-GEP Test and its clinical benefits.

To learn more information about SkylineDx and its commitment to improving melanoma care for a more personalized and effective approach to treatment, visit www.skylinedx.com.

About the Merlin CP-GEP 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. In addition, it is the only GEP test that provides binary stratification of all patients into High or Low Risk for metastasis, allowing clinicians to assign patients 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, and 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. Headquartered in Rotterdam, the Netherlands, SkylineDx maintains a strong U.S. presence with a CAP/CLIA certified laboratory in San Diego, California, and a nationwide commercial service organization that ensures full operational support across the U.S. market. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes:

Independent Dutch validation study of CP-GEP (Merlin Assay) for the prediction of nodal metastasis and long-term outcome in primary cutaneous melanoma patients. Lisanne P. Zijlker, Zahra Verwer, Bart A. van der Wiel, Anke M.J. Kuijpers, Michel W.J.M. Wouters, Winan J. van Houdt, Alexander C.J. van Akkooi. Link to the publication.

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