FoundationOne®CDx 

Our pioneering, FDA-validated, tissue-based, comprehensive genomic profiling service for solid tumours to help guide informed, personalised treatment decisions.1−3

What is FoundationOne CDx?

What is FoundationOne CDx?

Genes and genomic signatures

Genes and genomic signatures

Comprehensive assessment in a single test

FoundationOne CDx comprehensively examines the tumour genome, assessing the four main classes of genomic alteration 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

Validation

Validation

Based on FDA-approved comprehensive platform

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

IN-DEPTH REPORT

In-depth report

EU report includes EU-approved therapies to support clinical decision-making

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 Reports vary according to regional differences, e.g. EU reports list EU-approved therapy options to support clinical decision-making.§

CLINICAL USE IN SOLID CANCERS

Clinical use in solid cancers

Opens up treatment possibilities

FoundationOne CDx may detect clinically relevant genomic alterations missed by other tests, thereby opening up new treatment options.¥6–14

Saves tissue and time

FoundationOne CDx delivers all insights at once in a single test, saving tissue and time.

Ordering

Ordering

Order FoundationOne CDx

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 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; 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.