SkylineDx Publishes Landmark MERLIN_001 Trial in JAMA Surgery Validating the Predictive Power of the Merlin CP-GEP Test in Melanoma

"This study represents a major step forward in evaluating personalized melanoma care," said Vernon Sondak, MD, MERLIN_001 Principal Investigator and chair of the Cutaneous Oncology Department at Moffitt Cancer Center in Tampa, Florida. "Studying the Merlin CP-GEP Test's ability to distinguish patients' risk of sentinel node metastasis with a rigor and precision no other test or nomogram can match. Our results show that the test adds a level of accuracy above current clinical factors alone, even when factors like mitotic rate and histologic subtype are taken into account, and this kind of knowledge ultimately allows patients and surgeons to make better decisions about when sentinel node biopsy should be part of the management of clinically localized melanoma. In appropriately selected patients, this test can add value for shared decision-making."

"This study represents a major step forward in evaluating personalized melanoma care," said Vernon Sondak, MD, MERLIN_001 Principal Investigator and chair of the Cutaneous Oncology Department at Moffitt Cancer Center in Tampa, Florida. "Studying the Merlin CP-GEP Test's ability to distinguish patients' risk of sentinel node metastasis with a rigor and precision no other test or nomogram can match. Our results show that the test adds a level of accuracy above current clinical factors alone, even when factors like mitotic rate and histologic subtype are taken into account, and this kind of knowledge ultimately allows patients and surgeons to make better decisions about when sentinel node biopsy should be part of the management of clinically localized melanoma. In appropriately selected patients, this test can add value for shared decision-making."

Key Findings

The MERLIN_001 trial results published in JAMA Surgery can be found here: https://doi.org/10.1001/jamasurg.2025.4399.

About the 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 assigns 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 and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com.

About SkylineDx

SkylineDx is a biotechnology company focused on research and development of molecular diagnostics in oncology, and 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. Headquartered in Rotterdam, the Netherlands, SkylineDx maintains a strong U.S. presence with a CAP/CLIA certified laboratory in San Diego, California, and a nationwide commercial service organization that ensures full operational support across the U.S. market. To learn more about SkylineDx, please visit www.skylinedx.com.

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