SkylineDx's Merlin CP-GEP Granted FDA Breakthrough Device Designation, Building on Exclusive NCCN Recognition in Melanoma Care

• First and only melanoma gene expression profiling test that is both: Designated as an FDA Breakthrough Device and included in the NCCN guidelines for T1b and T2a cutaneous melanoma patients.
• FDA Breakthrough Designation acknowledges Merlin CP-GEP's ability to address a significant unmet clinical need and further validates the strength of the prospective clinical evidence generated through the MERLIN_001 study.

ROTTERDAM, Netherlands and SAN DIEGO, July 1, 2026 /PRNewswire/ -- SkylineDx,  innovative diagnostics company specializing in the research and development of molecular diagnostics for dermatology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Merlin CP-GEP¹ , a clinicopathologic gene expression profile (CP-GEP) test designed to support risk assessment and clinical decision-making in patients with early-stage cutaneous melanoma.

The FDA's Breakthrough Devices Program is designed to expedite the development and review process for novel technologies that may provide more effective diagnosis or management of life-threatening or irreversibly debilitating diseases, in the best interest of patients.

Supported by data from the largest prospective multi-center blinded clinical trial in cutaneous melanoma, MERLIN_001 trial ², the designation recognizes the potential of Merlin CP-GEP to support risk assessment and clinical decision-making in patients with stage IB (T1b/T2a) cutaneous melanoma. In conjunction with other established clinical criteria, Merlin CP-GEP supports patient selection for the sentinel lymph node biopsy procedure, may inform discussions regarding follow-up strategies, and facilitates shared decision-making between healthcare providers and patients.

"Breakthrough Device Designation underscores the potential of Merlin CP-GEP to advance personalized melanoma care and support more informed, patient-centered treatment decisions," said Dharminder Chahal, Chief Executive Officer of SkylineDx. "Patients deserve access to the best available tools supported by rigorous clinical evidence and recognized in clinical practice guidelines."

CP-GEP (Merlin CP-GEP) is already recognized by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a predictive GEP test that may be used to support metastatic risk assessment and clinical decision-making in T1b and T2a melanoma patients, a clinically important population in which accurate assessment of metastatic potential is critical for guiding management ³.

About the Merlin CP-GEP
Merlin 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. In addition, it is 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 may be obtained at 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.

Footnotes
(1) Merlin CP-GEP is marketed in the USA as an LDT. In the EU EEA and UK, it is marketed under the name Merlin Assay, a CE-IVD and UKCA marked device
(2) Gene Expression Profile–Based Test to Predict Melanoma Sentinel Node Status: The MERLIN_001 Study | Dermatology | JAMA Surgery | JAMA Network
(3) National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Cutaneous Melanoma (Version 2.2026)

Media Contact
ICR Healthcare
Ally Stubin
ally.stubin@icrhealthcare.com

SkylineDx Contact
Linda Forlani
press@skylinedx.com