*Base substitutions, insertions or deletions, copy number alterations and gene rearrangements.
†Clinical validation based on demonstrated concordance with the following companion diagnostics: cobas® EGFR Mutation Test, Ventana ALK (D5F3) CDx Assay, Vysis ALK Break-Apart FISH Probe Kit, therascreen® KRAS RGQ PCR Kit, Dako HER2 FISH PharmDx® Kit, cobas® BRAF V600 Mutation Test, THxID® BRAF kit. For more information, please see the FoundationOne®CDx Technical Information available at: www.rochefoundationmedicine.com/f1cdxtech.
‡For additional information on the NCCN categories please refer to the NCCN Compendium® (www.nccn.org).
§Therapies contained in the EU version of the report may have been approved through a centralised EU procedure or a national procedure in an EU Member State.
¥Based on a concordance study with FoundationOne®. FoundationOne CDx leverages the same comprehensive genomic profiling approach and is highly concordant with FoundationOne.
EGFR, epidermal growth factor receptor. FDA, US Food and Drug Administration. FISH, fluorescence in situ hybridisation. IHC, immunohistochemistry. MSI, microsatellite instability. NCCN, National Comprehensive Cancer Network. NGS, next generation sequencing. NSCLC, non-small cell lung cancer. PD-L1, programmed death-ligand 1.
TKI tyrosine kinase inhibitor. TMB, tumour mutational burden.