Independent meta-analyses by Melanoma Institute of Australia on CP-GEP model in Melanoma Care
Source: PR News Wire, October 2024
ROTTERDAM, Netherlands and SAN DIEGO, Oct. 24, 2024 /PRNewswire/ — SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, 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.
SLNB is a standard, yet invasive, procedure used to accurately stage melanoma and guide further treatment. Recommended for patients with melanomas that exceed a Breslow thickness of 1.0 mm, SLNB is crucial in detecting the spread of cancer to the lymph nodes. However, with a relatively low positive detection rate—only 15% to 20% of patients undergoing SLNB have nodal metastasis—many patients undergo the surgery unnecessarily. The Merlin CP-GEP model addresses this issue by identifying patients at low risk for nodal metastasis, allowing them to avoid unnecessary SLNB and its associated risks.
The MIA-led study analyzed data from independent external validation studies on the Merlin CP-GEP model published between 2020 and 2024. These studies spanned patient records from 4 countries, offering a comprehensive view of the model’s predictive accuracy. The analysis revealed that the CP-GEP model achieved a sensitivity of 93%, meaning it accurately identified 93% of patients with nodal metastasis, while achieving an NPV (Negative Predictive Value) of 95%, indicating that 95% of patients identified as low-risk truly did not have nodal metastasis. The model performed exceptionally well in patients with pT2 melanomas (1.01 – 2.0 mm thickness) [2], significantly reducing the number of unnecessary SLNB procedures. However, in patients with pT1 melanomas (?1.0 mm thickness) [2], heterogeneity in the data prevented reliable conclusions, highlighting the need for further research. The study [3] also confirmed that patients with pT3 and pT4 melanomas, due to their high risk of nodal metastasis, are less likely to benefit from the Merlin model, as SLNB is generally recommended for these more advanced cases as the risk for a positive node is higher.