FDA approves FoundationOneCDx as companion diagnostic for melanoma.- Foundation Medicine
This approval makes FoundationOneCDx the only comprehensive genomic profiling (CGP) test approved as a companion diagnostic across two groups of targeted therapies, representing an important step toward simplifying decision making for oncologists.
The first new therapeutics for which FoundationOneCDx is a companion diagnostic under the group approvals are Pfizer’s Braftovi/Mektovi and Novartis Tafinlar (dabrafenib) + Mekinist (trametinib) combination therapeutics. Moving forward FoundationOneCDx will automatically become a companion diagnostic for future BRAF inhibitors that are approved by the FDA under these groups.
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