Posted by Michael Wonder on 08 Dec 2021
FoundationOne CDx receives FDA approval as a companion diagnostic for BRAF inhibitor therapeutics in melanoma
8 December 2021 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as a companion diagnostic across a group of targeted therapies.
Foundation Medicine today announced that it has received approval from the U.S. FDA for FoundationOne CDx to be used as a companion diagnostic for two groups of current and future FDA approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations.
This approval makes FoundationOne CDx the only comprehensive genomic profiling test approved as a companion diagnostic across two groups of targeted therapies, representing an important step toward simplifying decision making for oncologists.
