The molecular test combines clinical variables and gene expression profiling to evaluate metastatic risk in patients with early-stage skin cancer.
The Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Merlin CP-GEP, a clinicopathologic gene expression profile test designed for risk assessment in patients with early-stage cutaneous melanoma, SkylineDx announced.
The FDA Breakthrough Devices Program aims to expedite the development and review of technologies that may provide more effective diagnosis or management of life-threatening or irreversibly debilitating diseases.
The designation recognizes the potential of the test to support clinical decision-making in patients with stage IB cutaneous melanoma. In conjunction with established clinical criteria, the test supports patient selection for sentinel lymph node biopsy procedures, informs 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,” says Dharminder Chahal, CEO of SkylineDx, in a release. “Patients deserve access to the best available tools supported by ‘rigorous’ clinical evidence and recognized in clinical practice guidelines.”
The test is already recognized by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a predictive test to support metastatic risk assessment in certain melanoma patients.
The test is a noninvasive prediction model and is the only commercially available gene expression profiling test that combines clinicopathologic variables with gene expression profiling into a single integrated algorithm, according to SkylineDx. The model provides a binary stratification of patients as high or low risk for metastasis, which helps assign them to surgical action categories listed in evidence-based cancer treatment and screening guidelines.
Developed by Mayo Clinic and SkylineDx, the test has been clinically validated in multiple studies, including the MERLIN_001 trial, a prospective, multi-center, blinded clinical trial. In the US, the test is marketed as a laboratory developed test.
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