ROTTERDAM, Netherlands and SAN DIEGO, March 5, 2026 /PRNewswire/ -- SkylineDx today announced the launch of the Guideline-Informed Risk Assessment Initiative, a clinical program designed to support surgeons and multidisciplinary teams in evaluating patients with T1 and T2 melanoma. The program aligns with the updated NCCN Guidelines®, where it is stated that CP-GEP (Merlin CP-GEP™¹) testing may be used in select patients with T1b ± T2a melanoma to support shared decision-making².
Each year in the United States, approximately 20,000 patients are diagnosed with T1b melanoma and 15,000 with T2a disease³. Despite guideline recommendations to consider and/or offer SLNB in these populations, an estimated 50% of T1b patients and 25% of T2a patients do not undergo SLNB⁴. In some cases, this may be due to patient-related factors; in others, decisions may be influenced by clinicopathologic features alone or by results from commercially available gene expression profile tests ('Alternative GEP' assays) not recommended within current guideline direction.
Merlin CP-GEP is the only gene expression profile assay prospectively validated in a large, multi-center blinded trial (MERLIN_001) to assess metastatic potential and SLN positivity risk. In this prospective validation study, patients classified as high risk by Merlin CP-GEP demonstrated approximately a three-fold increased risk of SLN involvement compared to low-risk patients⁵.
The NCCN Guidelines also include language stating that "alternative GEP tests for SLNB risk prediction are not recommended outside of the context of a clinical study or trial based on current data" ³. This distinction positions CP-GEP (Merlin CP-GEP) as a molecular assay recognized by NCCN Guidelines that may be used in specific T-categories to support SLN metastatic risk assessment.
"Melanoma mortality is not confined to advanced stages. A significant proportion of deaths occur in patients initially diagnosed with stage I and II disease," said Dharminder Chahal, CEO of SkylineDx. "By incorporating biologic metastatic potential into SLNB discussions and follow-up strategies for patients with cutaneous melanoma, we can move toward more precise, guideline-aligned care."
The Guideline-Informed Risk Assessment Initiative will:
Patient Impact
For patients diagnosed with melanoma, uncertainty regarding nodal involvement can significantly affect treatment decisions, anxiety levels, and long-term follow-up intensity. With access to a guideline-recognized test that integrates tumor biology into SLN risk assessment — and validated in a prospective, multi-center, blinded trial from top U.S. academic centers — patients and physicians can engage in more confident, personalized discussions about the potential benefit of SLNB and appropriate surveillance strategies. This initiative supports greater clarity and precision in early-stage melanoma care.
The Initiative will be formally introduced to the surgical oncology community at the Society of Surgical Oncology Annual Meeting, taking place March 5–7 in Phoenix, Arizona, where SkylineDx will share educational materials and clinical implementation resources.
For more information about the Guideline-Informed Risk Assessment Initiative and Merlin CP-GEP, please contact: clientservices@skylinedx.com
About the Merlin 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. 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.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
(1) Merlin CP-GEP is marketed in the USA as an LDT. In the EU EEA and UK, it is marketed under the name Merlin Assay, a CE-IVD and UKCA marked device.
(2) National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Cutaneous Melanoma (Version 1.2026)- section ME-2, ME-2A, ME-3A, ME-C 1 of 8, and ME-F 2 of 5. Link
(3) Sex-specific survival benefit in early skin melanoma based on 8th AJCC edition: an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) database - PMC
Ran Mo et al, 2021
Melanoma Skin Cancer Statistics | American Cancer Society last rev Jan 2026
Differences in Thickness-Specific Incidence and Factors Associated With Cutaneous Melanoma in the US From 2010 to 2018 | Dermatology | JAMA Oncology | JAMA Network Michael L. Chen et al, 2022
TABLE 3, Melanoma Staging - Cutaneous Melanoma - NCBI Bookshelf Chapter 6, Clinical Presentation and Staging of Melanoma, William H. Ward et al, 2017
Melanoma of the Skin — Cancer Stat Facts
Melanoma underreporting among US dermatopathologists: A pilot study - PubMed Heuring E & Chen SC., 2018
Melanoma reporting to central cancer registries by US dermatologists: an analysis of the persistent knowledge and practice gap - PubMed Cartee TV et al, 2011
Melanoma Thickness and Survival Trends in the United States, 1989 to 2009 - PubMed, Shaikh et al, 2016
(4) Hospital-Based Study of Compliance with NCCN Guidelines and Predictive Factors of Sentinel Lymph Node Biopsy in the Setting of Thin Melanoma Using the National Cancer Database - PubMed Hayek et al, 2018
(5) Gene Expression Profile–Based Test to Predict Melanoma Sentinel Node Status. The MERLIN_001 Study. Tina J. Hieken et al (Jama Surgery, October 2025)
Media Contact
ICR Healthcare
Alexis Feinberg
+1 203-939-2225
Alexis.feinberg@icrhealthcare.com
SkylineDx contact:
Linda Forlani
press@skylinedx.com
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