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 the licensed distributor of Foundation Medicine products outside of the US.
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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 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
When using different Foundation Medicine services across the patient journey, consistency of the reports aid comparison of the results.
TMB and MSI status, which may help predict response to immunotherapy, as well as LoH status, which may help inform the use of PARP inhibitors
Rules out important alterations that are not present
Relevant trials that your patient may be eligible for, based on their genomic profile and geographical location
Clinically relevant alterations in 324 tested cancer-related genes
Approved targeted therapies (ranked alphabetically within NCCN therapy categories)‡ for the patient's biomarker findings and genomic findings
To help you rule out uncertainty and determine the most appropriate course of action
Experience how FoundationOne CDx can help guide informed, personalised treatment decisions. Find out more about getting started.
PD-L 1 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 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.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine.
‡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. 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.