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SkylineDx Presents Breakthrough Data from Largest Melanoma Genomic Assay Trial at SMR Annual Meeting

NextEdge Admin

15 Oct 2024

2 min 50 sec

SkylineDx, a molecular diagnostics company focused on oncology, announced new results from the MERLIN_001 trial, the largest US multi-center study assessing the performance of a melanoma genomic assay. The first findings were shared in a late-breaking plenary session at the Society for Melanoma Research (SMR) Annual Meeting in New Orleans.

Led by Dr. Vernon Sondak (Moffitt Cancer Center), Dr. Terry Hieken (Mayo Clinic), and Dr. Michael Egger (UofL Health Brown Cancer Center), the trial involved 1,686 melanoma patients (T1-T3) across nine academic sites. It validated the predictive accuracy of the CP-GEP (Clinical-Pathologic and Gene Expression Profile) Merlin test in determining sentinel lymph node biopsy (SLNB) status for high-risk melanoma patients. SLNB is a standard staging procedure, but over 80% of biopsies reveal no metastasis, leading to unnecessary surgeries. The Merlin test offers a non-invasive solution by more accurately identifying low-risk patients, helping reduce unnecessary SLNBs and complications.

The trial showed that the Merlin test classified 37% of patients as Low-Risk, with only 7.1% having positive SLNs, yielding a 92.9% negative predictive value (NPV). High-Risk patients had a 23.8% SLN positivity rate, indicating the test’s ability to effectively stratify patients. Among T1 melanoma patients, 67% were classified as Low-Risk, with only 4.8% showing SLN metastasis.

The Merlin test integrates clinicopathologic factors like age and Breslow thickness with an 8-gene expression profile. It aligns with NCCN guidelines, guiding surgeons toward more precise, individualized care and reducing invasive procedures when appropriate. Commercially available in the US and Europe, it is marketed by Tempus as the Tempus Merlin test and by Quest Diagnostics as MelaNodal Predict™.

SkylineDx, based in Rotterdam and San Diego, focuses on transforming gene expression research into clinical diagnostics, improving patient outcomes through personalized care.