Natera’s Merlin CP-GEP Melanoma Assay Wins FDA Breakthrough Device Designation
NTRA•Natera’s SkylineDx-developed Merlin CP-GEP test for cutaneous melanoma received FDA Breakthrough Device designation, potentially accelerating its regulatory review and market introduction. The designation could expedite study design discussions and reimbursement planning, strengthening Natera’s oncology diagnostics pipeline.
1. Breakthrough Device Designation
FDA has granted Breakthrough Device designation to Merlin CP-GEP, a prognostic assay integrating gene expression profiling and clinicopathologic factors to stratify recurrence risk in early-stage cutaneous melanoma. This status allows Natera to engage FDA on accelerated study designs, interactive review, and potential priority review pathways.
2. Strategic Oncology Expansion
Merlin CP-GEP was developed by SkylineDx, now part of Natera’s Oncology unit, marking the company’s second program under the Breakthrough Device program after its liquid biopsy initiatives. The designation underscores Natera’s pivot beyond reproductive health into precision oncology diagnostics, diversifying its revenue streams.
3. Regulatory and Commercial Next Steps
Natera will leverage the Breakthrough Device program to finalize pivotal clinical protocols and negotiate labeling claims, aiming for a U.S. launch pending FDA clearance. The company plans to align with payors on reimbursement strategies to support adoption in melanoma clinical management.
