On March 5, 2026 SkylineDx reported 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-GEP¹) testing may be used in select patients with T1b ± T2a melanoma to support shared decision-making².

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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:

Support surgeons evaluating T1 and T2 melanoma patients where SLNB is being considered, declined, or has resulted in a negative test by integrating biologic metastatic risk assessment into clinical decision-making.
Empower patients with T1 and T2 melanoma to better understand their individualized risk of nodal metastasis through a guideline-recognized test, supporting more informed shared decision-making and surveillance planning.
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: [email protected]

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

(Press release, SkylineDx, MAR 5, 2026, View Source [SID1234663310])