Our pioneering, FDA-validated, tissue-based, comprehensive genomic profiling service for all solid tumours to help guide informed, personalised treatment decisions.1─3
This site is not intended to provide medical advice and/or treatment guidance. It is produced by Roche as a partner of Foundation Medicine.
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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.24,25
FoundationOne CDx is based on our analytically and clinically validated, FDA-approved comprehensive platform.3,4 You can be confident in the insights generated by FoundationOne CDx thanks to the review and approval of the workflow by the FDA, including analytical and clinical validation, and bioinformatics.3,4
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 alphabetically within 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
Experience how FoundationOne CDx can help guide informed, personalised treatment decisions. Find out more about getting started.
PD-L1 by IHC can be ordered as a supplemental test and may inform eligibility for several immunotherapies across many different cancer types.
*Base substitutions, insertions or deletions, copy number alterations and gene rearrangements.
†Clinical validation 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).
§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; LoH, Loss of Heterozygosity; IHC, immunohistochemistry; MSI, Microsatellite Instability; NCCN, National Comprehensive Cancer Network; NGS, next generation sequencing; NSCLC, non-small cell lung cancer; PARP, poly-ADP ribose polymerase; PD-L1, programmed cell death ligand 1; TKI, tyrosine kinase inhibitor; TMB, Tumour Mutational Burden.