SkylineDx’s Merlin CP-GEP Granted FDA Breakthrough Device Designation

By Karen Roman

SkylineDx said the FDA granted Breakthrough Device Designation to Merlin CP-GEP, the company’s gene expression profile test for risk assessment and clinical decision-making in patients with early-stage cutaneous melanoma.

The Merlin CP-GEP is the first and only melanoma gene expression profiling test to have this FDA designation and to be included in the NCCN guidelines for T1b and T2a cutaneous melanoma patients, the company stated.

Never Miss our Weekly Highlights HERE

“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, SkylineDx CEO. “Patients deserve access to the best available tools supported by rigorous clinical evidence and recognized in clinical practice guidelines.”