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FDA Approves Melanoma BRAF Companion Test
The assay is indicated to identify patients with advanced melanoma who have BRAF V600E or BRAF V600K variants and may benefit from FDA-approved targeted therapies.
To announce the FDA approval of PGDx elio tissue complete CDx as a companion diagnostic for advanced melanoma.
Approach:
Diagnostic Technology: PGDx elio tissue complete CDx is a qualitative in vitro diagnostic that uses next-generation sequencing to analyze DNA from tumor tissue.
Key Findings:
The test identifies patients with advanced melanoma who have BRAF V600E or BRAF V600K variants.
Melanoma has the highest mortality rate among skin cancers, with a 5-year survival rate of 16% for stage IV melanoma.
Water-related activities were the most commonly reported setting for recent sunburn, while more than one-half of respondents reported sunscreen use at the time of their most recent sunburn.
