SkylineDx Announces Presentation of New Data Highlighting the Predictive Power of the CP-GEP Merlin Test for T1a Cutaneous Melanoma Patients at the 21st International Congress of the Society for Melanoma Research

The Merlin Test  (CP-GEP) Accurately Stratifies Cutaneous Melanoma Patients as Low Risk or High Risk for Sentinel Lymph Node Metastases Impacting Clinical Decision Making

• Merlin test  (CP-GEP) [1] successfully stratifies T1a melanoma patients considered for sentinel lymph node biopsy (SLNB) by their care providers, reducing SLNB surgeries by 87.6% with a negative predictive value (NPV) of 98.5%.
• Merlin test  (CP-GEP) identifies high-risk T1a melanoma patients for SLNB surgery, even those who might be missed due to the absence of conventional adverse features, offering a more precise and individualized approach to managing early-stage melanoma.

ROTTERDAM, Netherlands and SAN DIEGO, Oct. 11, 2024 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases today announced that new clinical data on the efficacy of its Merlin test will be presented at the 21st International Congress of the Society for Melanoma Research (SMR) Annual Meeting 2024 in New Orleans [2].

The study, which assessed the clinical utility and performance of Merlin test in T1a melanoma patients, showed that it dramatically improves the ability to differentiate between low- and high-risk T1a patients. Merlin test identified 88% of patients as Low Risk, resulting in a post-test SLN positivity rate of only 1.5% among those classified as Merlin Low Risk. Conversely, 12% of patients were classified as High Risk, with a significantly higher SLN positivity rate of 15.8% among those identified as Merlin test High Risk. These findings highlight the test's potential to reduce unnecessary SLNB surgeries, preventing overtreatment in the vast majority of patients while ensuring high-risk individuals receive appropriate care.

Alexander Meves, M.D., MBA, dermatologist at Mayo Clinic and principal inventor of the CP-GEP model, shared: "The intent is to help prevent undertreatment in seemingly low-risk early-stage melanoma patients who are actually at risk for nodal metastasis. By accurately identifying these at-risk individuals, we ensure that they receive the necessary interventions, even in the absence of traditional clinical risk factors."

For patients with at least one traditional adverse feature, such as age under 40, lymph vascular invasion, or a high mitotic rate, Merlin test identified 37 patients as Low Risk, all with a post-test SLN positivity rate of 0%. Additionally, among 104 patients without any adverse features, the Merlin test still identified 7 patients as High Risk, with a post-test SLN positivity rate of 14.3%. These results demonstrate that Merlin test effectively pinpoints high-risk individuals who might otherwise go untreated under traditional guidelines.

This latest data highlights the importance of Merlin test in transforming early-stage melanoma treatment. Merlin test provides clinicians with a robust, evidence-based tool to tailor SLNB surgery decisions, minimizing unnecessary surgeries while ensuring that high-risk patients receive appropriate care. With the ongoing advancements in genomic testing and personalized medicine, the Merlin test offers a new standard of care that has the potential to improve outcomes for countless melanoma patients.

About CP-GEP (Merlin test)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to stratify patients based on being high or low risk for metastasis and thereby categorize them in the appropriate surgical action categories listed in evidence-based cancer treatment, prevention and screening guidelines. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase access. In the United States, Tempus is commercializing the Tempus Merlin test.
Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict^™.

About SkylineDx

SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology, inflammatory, and infectious diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam, the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego, California, USA. To learn more about SkylineDx, please visit www.skylinedx.com.

Footnotes:

1. Bellomo et al., Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology (2020). https://doi.org/10.1200/PO.19.00206
2. Yu et al. CP-GEP Identifies T1a Melanoma Patients at Risk of Sentinel Lymph Node Metastasis.  https://falconprogram.com/files/SMR%202024%20T1a.pdf