*TMB reported in FoundationOne CDx and FoundationOne Heme. MSI reported in FoundationOne CDx, FoundationOne Liquid and FoundationOne Heme.
†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 Specifications available at: www.rochefoundationmedicine.com/f1cdxtech.
FDA, US Food and Drug Administration. MSI, microsatellite instability. NGS, next generation sequencing. TMB, tumour mutational burden.