Merlin CP-GEP Becomes the First and Only Gene Expression Profile (GEP) Test Recommended by NCCN® Cutaneous Melanoma Guidelines to Assess Metastatic Risk

• Merlin CP-GEP is the only molecular test recognized by NCCN as predictive and appropriate for use in select T1 and T2 patients to support shared decision-making regarding Sentinel Lymph Node Biopsy.
• NCCN guidelines highlight that patients identified as Merlin High Risk may have a threefold increased risk of sentinel lymph node (SLN) involvement based on recently published data from the largest prospective, blinded trial for a molecular test in cutaneous melanoma.

SAN DIEGO and ROTTERDAM, Netherlands, Feb. 19, 2026 /PRNewswire/ -- 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 Merlin CP-GEP¹ (clinicopathologic–gene expression profile test) as the first and only molecular test that may be used in select early-stage melanoma patients.

The NCCN Melanoma Panel specifically highlighted patients with T1b and T2a melanoma — a clinically important population in which accurate assessment of metastatic potential is critical for guiding management. The guidelines reference prospective data from the MERLIN_001 trial demonstrating that patients identified as high risk by 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 updated guidelines also clearly differentiate Merlin CP-GEP from other commercially available gene expression profile assays. Certain tests, including Castle Biosciences DecisionDx® Melanoma, have been promoted for SLNB risk assessment. The NCCN Melanoma Panel specifically addressed these "alternative" GEP assays and stated that alternative GEP tests for SLNB risk prediction are not recommended outside of a clinical trial based on current data³. This distinction positions Merlin CP-GEP as the only molecular assay recognized by NCCN for clinical use in this setting.

"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's recognition of 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 M2-A ME-2A, ME-3A, ME-C 1 of 8, and ME-F 2 of 5. Link

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