Foundation Medicine companion diagnostic garners FDA approval

Dec. 9, 2021

Foundation Medicine announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma.

These therapies include BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations.

Melanoma is a serious form of skin cancer that accounts for an estimated 207,790 cases each year. BRAF mutations are the most common type of mutation in melanoma and are present in more than half of all melanoma cases.

The first new therapeutics for which FoundationOne CDx is a companion diagnostic under the group approvals are Pfizer’s BRAFTOVI/MEKTOVI and Novartis Tafinlar (dabrafenib) + Mekinist (trametinib) combination therapeutics. Moving forward FoundationOne CDx will automatically become a companion diagnostic for future BRAF inhibitors that are approved by the FDA under these groups.

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens.

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