merlin

Sentinel lymph node (SLN) status alone is not sufficient as node negative patients still experience relapse and melanoma-related death. Validates Merlin CP-GEP's prognostic power: Identifying tumors at high-risk for relapse that would otherwise be missed by traditional clinical and pathological evaluations. ROTTERDAM, Netherlands and SAN DIEGO, April 4, 2025 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in molecular diagnostics for oncology, inflammatory, and infectious diseases, proudly announces that Dr. Teresa Amaral, MD, PhD, Head of Skin Cancer Clinical Trials Center, University of Tübingen, Germany, will present groundbreaking new data at the 2025 World Congress of Melanoma (WCM). The presentation will highlight the Merlin CP-GEP (Clinicopathologic and Gene Expression Profile) test's ability to identify high-risk melanoma patients who did not undergo sentinel lymph node biopsy (SLNB), a critical gap in current melanoma staging methods – showing CP-GEP's potential in predicting relapse and other long-term survival outcomes [1-2]. Key Findings from the Study: Merlin CP-GEP test successfully stratified 930 stage I/II melanoma patients: 879 (94.5%) were Merlin Low-Risk and 51 (5.5%) were Merlin High-Risk. Patients identified as Low-Risk showed an impressive 5-year and 10-year relapse-free survival (RFS) rate of 96% and 94.5% respectively. Patients in the Merlin (CP-GEP) High-Risk group were around 20 times more likely to experience a recurrence, compared to the Merlin Low-Risk group. Their 5-year and 10-year RFS was 37.5% for both endpoints. Additionally, High-Risk patients showed significantly increased rates of distant metastasis and melanoma-specific death, reinforcing the clinical value of CP-GEP in identifying patients at risk for recurrence. While SLNB remains the standard for melanoma staging, many patients classified as low-risk based on traditional methods still experience relapse or even death. The CP-GEP model, which combines gene expression data with clinical factors age and tumor thickness, effectively identified two distinct risk groups among patients who did not undergo SLNB. Dr. Teresa Amaral shared her thoughts on the study: "The results of this study highlight the potential of the Merlin CP-GEP test to redefine risk assessment for melanoma patients. By identifying high-risk individuals who may not have undergone SLNB, we can better personalize treatment decisions, ultimately improving long-term outcomes for patients." Dr. Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx, commented, "These results highlight the power of CP-GEP in helping clinicians identify high-risk patients, even in the absence of SLNB status. Additional research is needed but potentially the Merlin High-Risk patients could benefit from systemic therapy to overcome their risk of recurrence, as their RFS is similar to that of patients who are currently eligible for immunotherapy." SkylineDx remains committed to advancing innovative molecular diagnostic solutions that offer better insights and more personalized treatment options for melanoma patients, ultimately improving their chances for a better outcome. About the advanced cutaneous melanoma GEP test (Merlin CP-GEP test) CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx BV and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. More information (including references) may be obtained at and . 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 patient access. 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 . Footnotes: 1. T. Amaral et.al. Identification of patients at high risk for relapse using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients (pts) with stage I/II melanoma who did not undergo sentinel lymph node biopsy. Abstract at WMC 2025: tuebingen-930-eado2025.pdf 2. T. Amaral, E. Chatziioannou, A. Nuebling, et al. Risk stratification using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients with clinical stage I/II melanoma who did not undergo sentinel lymph node biopsy. Eur J Cancer (2025). SOURCE SkylineDx WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Merlin CP-GEP test delivers high clinical utility – Study prospectively confirms precise risk stratification, optimizing SLNB referral recommendations. High clinical impact in subgroups – Merlin Low Risk patients show high negative predictive value (NPV), while Merlin High Risk patients exceed SLNB recommendation thresholds. ROTTERDAM, Netherlands and SAN DIEGO, March 28, 2025 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology , inflammatory and infectious diseases, proudly announces Dr. Tina Hieken, a surgical oncologist at Mayo Clinic and one of the principal investigators of the groundbreaking MERLIN_001 study, will present new data at the 2025 Society of Surgical Oncology (SSO) Annual Meeting [1]. Dr. Hieken's presentation, titled Prospective Multicenter Evaluation (MERLIN_001 Trial) of a Clinicopathologic and Gene Expression Profile Test to Predict Sentinel Node Status in T1-T3 cN0 Melanoma, will showcase the final results of this pivotal study, which demonstrates the accuracy of the Merlin CP-GEP test in predicting sentinel lymph node (SLN) metastases in melanoma patients. The MERLIN_001 trial is the largest prospective, blinded study, to evaluate the Merlin CP-GEP test, which is the only commercially avialable GEP test that combines clinical, pathological, and gene expression data into a single algorithm to predict SLN positivity. The study was conducted at 9 renowned US hospitals, which are also top-ranking oncology academic centers. The study's findings validate the test's superior predictive accuracy compared to traditional clinical and pathological factors, which currently guide sentinel lymph node biopsy (SLNB) decisions in melanoma. A total of 1,802 patients were included for whom SLN biopsy material was available. CP-GEP achieved an assay success rate of 97.7%, thus a total of 1,761 patients could be enrolled. The National Comprehensive Cancer Network (NCCN) clinical guidelines recommend SLNB surgery for patients with >10% risk of nodal metastases. This cohort had a 17.6% overall SLNB positivity rate, suggesting effective referral of patients based on current factors. However, 82.4% of patients had a negative sentinel node suggesting no therapeutic benefit from the sentinel node operation. How did Merlin CP-GEP test provide more precise risk stratification, allowing physicians to further optimize SLNB referral decisions and personalize treatment plans? Key findings from the MERLIN_001 study: In this cohort a total of 31 T1a patients with adverse features were referred for SLNB surgery. Merlin identified 80.6% as Low Risk for nodal metastases at a negative predictive value (NPV) of 100%. These patients could consider forgoing SLNB surgery as their risk of nodal metastases is close to 0%. Six patients were identified as Merlin High Risk. Their risk of metastases was with 16.7% well above the >10% guideline threshold, therefore these patients should be referred for surgery. Among the 479 T1b patients, Merlin test identified 67.6% as Low Risk for nodal metastases with a 94.8% NPV. These patients could consider forgoing SLNB surgery as their risk of metastases is close to 5%. Additionally, T1b patients with a Merlin High Risk label had a 16.1% SLNB positivity rate and should be referred for surgery. The study's findings are particularly significant for T2a melanoma patients. This patient subgroup had an SLN positivity rate of 15.5%. Merlin test identified 36.6% as Low Risk at an NPV of 91.9%, reducing their metastatic risk below the 10% threshold for SLNB surgery recommendation. Reclassification of these T2a patients gives them access to more personalized treatment options. The Merlin CP-GEP test also demonstrated exceptional performance in other subgroups, particularly in head and neck melanoma patients. SLNB surgery in this group poses unique challenges due to complex lymphatic drainage and vital anatomical structures. Merlin test identified 43.3% as Low Risk for nodal metastases with an NPV of 95.1%. These patients could consider forgoing SLNB surgery as their risk of metastases is below 5%. "The MERLIN_001 study provides a transformative approach to melanoma risk assessment, ensuring that we can better personalize care for our patients. The test not only refines risk stratification but also addresses critical subgroups, such as head and neck melanoma patients and elderly individuals, who often face complex treatment decisions. By leveraging this groundbreaking tool, we can confidently guide SLNB recommendations and optimizing patient outcomes," said Dr. Tina Hieken. "The MERLIN_001 study results are a breakthrough in melanoma care," said Dharminder Chahal, CEO of SkylineDx. "As the only company to have conducted this large, prospective, blinded trial of the Merlin CP-GEP test in collaboration with esteemed academic institutions in the U.S., we are committed to empowering clinicians with a rigorously validated test backed by high-quality evidence, ensuring patients receive the most informed care possible ." The MERLIN_001 study represents a major milestone in melanoma research, with the potential to enhance clinical decision-making and improve patient outcomes. By offering more accurate risk assessments, the Merlin CP-GEP test empowers healthcare providers to tailor treatment plans to the specific needs of melanoma patients. About the advanced cutaneous melanoma GEP test (Merlin CP-GEP test) CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced generation CP-GEP model was developed by Mayo Clinic and SkylineDx BV and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. More information (including references) may be obtained at and . 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 patient access. 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 . Footnotes: 1. T. Hieken et. al. Prospective multicenter evaluation (MERLIN_001 trial, NCT04759781) of a clinicopathologic and gene expression profile test to predict sentinel node status in T1-T3 cN0 melanoma SSO-2025-Heiken.pdf SOURCE SkylineDx WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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 and 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 . 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 SOURCE SkylineDx WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED