Our extensively validated, tissue-based comprehensive genomic profiling service for all solid tumours that helps guide efficient, personalised treatment decisions.1,2
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FoundationOne CDx comprehensively examines the tumour genome, assessing the four main classes of genomic alterations in 324 known cancer-relevant genes, while also reporting TMB and MSI, which can help inform eligibility for
immunotherapies.1,2,15-23 In addition, FoundationOne CDx reports high Loss of Heterozygosity (LoH), which may reflect if a tumour is homologous recombination deficient (HRD+) and which can help inform the use of poly-ADP ribose polymerase (PARP) inhibitors.24,2S
A clear, in-depth report provides insights on your patient's genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials.5 Approved therapies are ranked alphabetica lly with in NCCN therapy categories.‡ The report also highlights important disease-relevant genes with no reportable alterations identified and genomic alterations associated with potential resistance to therapy to help rule out potentially ineffective treatment.5 Reports vary according to regional differences, e.g. EU reports list EU-approved therapy options to support clinical decision-making.§
When using different Foundation Medicine services across the patient journey, consistency of the reports aid comparison of the results.
*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.