SkylineDx Receives FDA Breakthrough Designation for Merlin Melanoma Test

SkylineDx has received Breakthrough Device Designation from the US Food and Drug Administration for Merlin CP-GEP, a molecular diagnostic test designed to support risk assessment and clinical decision-making in patients with early-stage cutaneous melanoma.
The designation recognises the potential of the test to help assess metastatic risk in patients with stage IB melanoma, particularly those classified as T1b or T2a. 

When considered alongside established clinical factors, Merlin CP-GEP can support decisions around sentinel lymph node biopsy, follow-up planning and discussions between clinicians and patients.

The test combines clinicopathologic information with gene expression profiling through an integrated algorithm. 

It provides a binary assessment that categorises patients according to their risk of melanoma metastasis, helping clinicians consider appropriate management strategies.

Evidence supporting the technology includes findings from the MERLIN_001 trial, described as a large prospective, multi-centre, blinded clinical study in cutaneous melanoma.

Merlin CP-GEP is also recognised in the National Comprehensive Cancer Network (NCCN) Clinical Practice 

Guidelines in Oncology as a predictive gene expression profile test that may support metastatic risk assessment and clinical decision-making for selected T1b and T2a melanoma patients.

The Breakthrough Devices Programme is intended to accelerate the development and regulatory review of technologies that could provide more effective diagnosis or management of serious conditions.