SkylineDx,  an innovative diagnostics company specialising in the research and development of molecular diagnostics for dermatology and oncology, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Merlin CP-GEP, 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-centre blinded clinical trial in cutaneous melanoma, the MERLIN_001 trial, the designation recognises 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 personalised melanoma care and support more informed, patient-centred treatment decisions," said Dharminder Chahal, Chief Executive Officer of SkylineDx. "Patients deserve access to the best available tools supported by rigorous clinical evidence and recognised in clinical practice guidelines."