*Base substitutions, insertions or deletions, copy number alterations and gene rearrangements.
†Analytical 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 Specifications.
‡Therapies contained in 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 CGP approach and is highly concordant with FoundationOne.1
CGP: comprehensive genomic profiling; EGFR: epidermal growth factor receptor; EMA: European Medicines Agency; FISH: fluorescence in situ hybridisation; IHC: immunohistochemistry; MSI: microsatellite instability; NSCLC: non-small cell lung cancer; TMB: tumour mutational burden.
M-GB-00001595 September 2020