SkylineDx, a diagnostics company focused on molecular diagnostics, has announced new, positive data from a trial evaluating the Merlin test (CP-GEP) on melanoma patients.
The Merlin test is based on the CP-GEP model, a non-invasive prediction model for cutaneous melanoma patients. It combines clinicopathologic (CP) variables with gene expression profiling (GEP).
Developed by Mayo Clinic and the Netherlands-based SkylineDx, the model has been clinically validated in multiple studies.
The MERLIN_001 trial is said to be the largest US multi-centre trial evaluating a melanoma genomic assay.
The initial findings were presented during a plenary session for late-breaking abstracts at the Society for Melanoma Research (SMR) Annual Meeting in New Orleans.
The trial, conducted at nine academic sites across the US, included 1,686 melanoma patients (T1-T3) who underwent sentinel lymph node biopsy (SLNB). It validated the predictive power of the CP-GEP Merlin test in identifying SLNB status in high-risk cutaneous melanoma patients.
The Merlin test has been validated in a population with an overall sentinel lymph node (SLN) positivity rate exceeding 17%.
The Merlin test classified 37% of these patients as Low Risk, with only 7.1% having a positive SLN, resulting in a negative predictive value (NPV) of 92.9%.
In contrast, 23.8% of High-Risk patients had positive SLNs, demonstrating the test’s effectiveness in stratifying risk levels.
For the thinnest melanomas (T1), 67% were classified as Merlin Low Risk, with an SLNB positivity rate of just 4.8%.
Additionally, the Merlin test allows surgeons to consider less aggressive treatment options by identifying T2 patients at lower risk for nodal metastasis.
MERLIN_001 trial principal investigator Vernon Sondak said: “This landmark trial will allow us to have more informed conversations with our patients about their surgical treatment options.
“These results provide critical insights for clinicians, allowing us to move toward more precise and individualised care.”
Concurrently, SkylineDx presented positive results from T1a cutaneous melanoma patients’ trial of the CP-GEP Merlin test.
The results showed that the test accurately stratifies cutaneous melanoma patients as low-risk or high-risk for sentinel lymph node metastases.
SkylineDx collaborates with diagnostic service providers worldwide to enhance access to this test.
In the US, Tempus is commercialising the Tempus Merlin test. Additionally, Quest Diagnostics has launched its own LDT version of the CP-GEP model in the US under the brand name MelaNodal Predict.
