- “Findings of the prospective Merlin_001 trial suggest that CP-GEP testing may be used in select patients with T1b ± T2a melanoma to support shared decision-making, when a patient or provider would decide against SLNB if the true risk was <10%.”³
- “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
San Diego, CA & Rotterdam, Netherlands- February 19, 2026 — SkylineDx today announced that the National Comprehensive Cancer Network® (NCCN®) has updated its Clinical Practice Guidelines in Oncology for Cutaneous Melanoma (Version 1.2026), recognizing the CP-GEP (Merlin CP-GEP¹) test may be used to support metastatic risk assessment in T1b and T2a melanoma patients, a clinically important population in which accurate assessment of metastatic potential is critical for guiding management..
The NCCN Guidelines® reference prospective data from the MERLIN_001 trial demonstrating that patients identified as high risk by CP-GEP (Merlin CP-GEP) may have approximately a threefold increased likelihood of sentinel lymph node positivity². These findings underscore Merlin CP-GEP’s ability to provide biologically informed risk stratification, helping physicians better understand metastatic risk beyond traditional clinicopathologic features alone.
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 outside of a clinical study or trial to support metastatic risk assessment.
“This update is an important step toward supporting more informed and individualized care for patients with melanoma,” said Dharminder Chahal, CEO, SkylineDx. “Patients with early-stage melanoma deserve risk assessment tools that are rigorously validated and grounded in prospective evidence. NCCN Guideline’s recognition of CP-GEP (Merlin CP-GEP) reflects the importance of using rigorously validated, predictive tests to better understand metastatic potential and support more informed clinical management.”
Merlin CP-GEP integrates clinicopathologic features with gene expression data to provide a more accurate and individualized assessment of metastatic risk in patients with early-stage cutaneous melanoma. By biologically refining risk beyond traditional staging alone, Merlin CP-GEP helps physicians and patients make more informed treatment and management decisions, supporting care that is better aligned with each patient’s true metastatic potential.
SkylineDx continues to generate long-term prospective outcome data through the ongoing MERLIN_001 study and remains committed to advancing precision medicine in early-stage melanoma. For more information, visit www.merlinmelanomatest.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) Gene Expression Profile–Based Test to Predict Melanoma Sentinel Node Status. The MERLIN_001 Study. Tina J. Hieken et al (Jama Surgery, October 2025) Link to the publication
(3) 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
“NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way”