SkylineDx Announces Data from Largest Prospective Multi-Center Melanoma Gene Expression Profiling Trial at 21st International Congress of the Society for Melanoma Research

The Merlin test (CP-GEP) stratifies melanoma patients based on risk for sentinel lymph node (SLN) metastasis, offering a powerful tool for risk-based decision-making.

ROTTERDAM, Netherlands and SAN DIEGO, Oct. 13, 2024 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, announced today new data from the MERLIN_001 prospective US multi-center trial, the largest trial ever conducted to assess the performance of a melanoma genomic assay.  The first results from this landmark study were presented in a plenary session for late-breaking abstracts at the Society for Melanoma Research (SMR) Annual Meeting in New Orleans [1].

The trial, conducted at nine academic sites in the United States  has been successfully led by three principal investigators Dr. V. Sondak  M.D., Chair of the Department of Cutaneous Oncology at Moffitt Cancer Center, Dr. T. Hieken, M.D., Surgical Oncologist and Professor of Surgery, Mayo Clinic, and Dr. M. Egger M.D., M.P.H., Associate Professor, Surgical Oncologist UofL Health Brown  Cancer Center Louisville. The trial validated the predictive power of the CP-GEP (Clinical-Pathologic and Gene Expression Profile)  Merlin test in identifying sentinel lymph node biopsy (SLNB) status in high risk cutaneous melanoma patients.

Sentinel lymph node biopsy is a critical staging procedure in melanoma, often recommended for patients with a predicted SLN metastasis risk of >10%. However, more than 80% of these operations reveal no metastasis, exposing patients to risks of complications, without therapeutic benefit. Merlin test aims to solve this problem by more accurately identifying patients at low risk for SLN metastasis, helping clinicians make informed decisions about optimal selection of patients for SLNB.

Vernon Sondak, one of the three principal investigators of the MERLIN_001 trial, stated:

"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 individualized care."

The Merlin test, which integrates clinicopathologic factors such as age and Breslow thickness with an 8-gene expression profile, has now been validated prospectively in a population with an overall SLN positivity rate of over 17%. The study results demonstrate the predictive power of the Merlin test and potential in guiding clinical decisions.

The study encompassed 1,686 melanoma patients (T1-T3), all of whom underwent SLNB, and demonstrated that Merlin test could classify 37% of them as Low Risk. Among these Low-Risk patients, only 7.1% had a positive SLN, resulting in a negative predictive value (NPV) of 92.9%. In contrast, 23.8% of High-Risk patients had positive SLNs, showcasing the test's ability to stratify patients according to their risk levels.

In the thinnest melanomas (T1): 496 patients with a pre-test risk of 8.9% for nodal metastasis, 67% were classified as Merlin Low-Risk, with an SLNB positivity rate of only 4.8%.

By also identifying T2 patients who have a lower risk of nodal metastasis, the Merlin test enables surgeons to explore alternative, less aggressive treatment paths where appropriate, improving individualized care. Low-Risk patients saw a significant reduction in SLNB positivity, while High-Risk patients had 3-fold higher likelihood of SLN positivity, aligning with NCCN guidelines for SLNB referral. 

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 the access. In the United States, Tempus is commercializing 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. Sondak et al., Prospective multicenter evaluation (MERLIN_001 trial) of a clinicopathologic and gene expression profile test to predict sentinel node status in T1-T3 cN0 melanoma https://falconprogram.com/files/SMR%202024%20Abstract%20MERLIN_001.pdf