Posted by Michael Wonder on 17 Mar 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for EGFR therapeutics targeting exon 19 deletions or exon 21 substitutions in non-small cell lung cancer
17 March 2022 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as a companion diagnostic for a third group of targeted therapies.
Foundation Medicine today announced it has received approval from the U.S. FDA for FoundationOne CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer whose tumours have epidermal growth factor receptor EGFR exon 19 deletions or exon 21 alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors approved by FDA for this indication.
