TEST:

Merlin Assay

"SkylineDx...today announced that results from its landmark MERLIN_001 trial, the largest prospective evaluation of a genomic test in cutaneous melanoma, have been published in the October 2025 issue of JAMA Surgery, the most cited surgery journal in the world. The study demonstrates that the Merlin CP-GEP Test stratified T1-T3 melanomas with clearly distinct risk levels for sentinel node metastasis: patients with a High-Risk result had a three-fold higher rate of sentinel node metastasis compared to those with a Low-Risk result (23.8% vs. 7.1%) overall."

"SkylineDx...will launch its new European patient access program, Merlin for Me®, at the ADO Congress 2025. During an industry symposium, SkylineDx will also present how Merlin Assay’s gene expression (CP-GEP) analyses can precisely assess the risk of primary melanoma recurrence, based on recent scientific studies."

"SkylineDx...today announced detailed results from a Danish validation study, published in the Journal of Surgical Oncology. The study demonstrates that SkylineDx’s Merlin Assay (CP-GEP) can identify cutaneous melanoma patients, in particular pT1 and pT2 patients, that have a low risk for nodal metastasis and therefore may forgo Sentinel lymph node biopsy (SLNB) surgery. Merlin is a genomic test to guide treatment decisions in early-stage melanoma."

"SkylineDx...announced today an independent meta-analysis in Critical Reviews of Oncology/Hematology. The study demonstrates that SkylineDx’s Merlin CP-GEP Assay accurately stratifies patients with cutaneous melanoma for optimal selection for sentinel lymph node biopsy (SLNB), an invasive surgical procedure with the potential for complications. Merlin is a genomic test to guide treatment decisions in early-stage melanoma"

This meta-analysis suggests that the CP-GEP model can reduce the number of unnecessary SLNBs performed, especially in pT2 patients. It can improve clinical decision making and assist in patients' informed consent. Broader implications such as potential reductions in healthcare costs and risks of surgical complications should be explored further.

"SkylineDx...presenteda new independent study at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating that its Merlin Assay (CP-GEP), a genomic test to guide treatment decisions in early-stage melanoma, can reliably identify patients with head and neck (H&N) melanoma at high risk for recurrence—even in the absence of sentinel lymph node biopsy (SLNB)"

This study shows that CP-GEP has the potential to stratify patients with early-stage melanoma who did not undergo SLNB based on their risk of recurrence. Patients with CP-GEP Low Risk have a significantly better long-term survival. CP-GEP shows to be promising for guiding SLNB referral and may support melanoma care by optimizing personalized treatment plans and potential surveillance regimens.

"SkylineDx...will present groundbreaking new data at the 2025 World Congress of Melanoma (WCM). The presentation will highlight the Merlin CP-GEP (Clinicopathologic and Gene Expression Profile) test’s ability to identify high-risk melanoma patients who did not undergo sentinel lymph node biopsy (SLNB), a critical gap in current melanoma staging methods – showing CP-GEP’s potential in predicting relapse and other long-term survival outcomes [1-2]."

Our observations support the effectiveness of Merlin IHC in differentiating PM from RMP. However, investigators should be familiar with potential challenges in interpreting Merlin IHC results, especially in CBs.

P=NA | N=250 | "The study analyzed 250 patients with stage I-III head and neck melanoma diagnosed between 2004 and 2021. All of the patients in the study underwent a sentinel lymph node biopsy, which is essential for assessing the predictive power and accuracy of the Merlin test. The Merlin test classified 40.8% of patients as Low Risk for nodal metastases, predicting a corresponding 40.8% reduction in SLNB procedures, with a high negative predictive value (NPV) of 98%. This means that 98% of the patients with a Merlin test 'Low Risk' result actually did have a negative sentinel lymph node biopsy. Among the SLNB-negative patients, the test identified 100 individuals as 'Low Risk' with a five-year melanoma-specific survival (MSS) of 95.3%. In the subgroup T1-T2 patients, the test achieved a 56.3% SLNB reduction rate with an excellent NPV of 98.9%."

The Merlin Assay effectively categorizes head and neck melanoma patients by risk, enabling more accurate clinical decision-making regarding SLNB and follow-up evaluation, especially for early-stage melanoma patients.

"SkylineDx...announced today the results of a comprehensive systematic review and meta-analysis conducted by Melanoma Institute of Australia (MIA). This independent study validates the predictive power of SkylineDx's Clinicopathologic Gene Expression Profile (CP-GEP) model, known as the Merlin test, in guiding the decision-making process for Sentinel Lymph Node Biopsy (SLNB) in patients with cutaneous melanoma."