Scienza e Tecnologia
SkylineDx presents landmark findings from the largest prospective multicenter melanoma GEP trial at SSO 2025
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:
"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.
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 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 patient access.
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.
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
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