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

FoundationOne CDx

What is FoundationOne®CDx?

Untitled-4A single, tissue-andtime-savingtestDelivers all insightsat oncein a singletest, thus savingtissue and timeversussequential biomarkertesting1,2,6Supports clinicaldecision-makingClear, in-depthreportprovides insights on thegenomic profile ofyourpatient aswell asassociated targetedtherapies, immunotherapies(ranked alphabeticallywithin NCCN therapycategories) and relevantclinical trials5FDA

 

 

Genes and biomarkers

Comprehensive assessment in a single test

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
Tumour mutational burdenBase SubstitutionsInsertions and deletionsCopy number alterationsRearrangementsMicrosatellite instabilityMSILoHTMBAnalyses324known cancer-relevant genes

 

 

Validation

Based on FDA-approved comprehensive platform

Review and approval of the FoundationOne CDx platform workflow by the FDA

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

Review and approval of the FoundationOne CDx platform workflow by the FDA

Analytical validation Clinical validation Bioinformatics




What is the difference between analytical and clinical validation?

Analytical validationClinical validationWhat does it mean?Ability to detect and measure the presence of a biomarker of interest accurately, reproducibly and reliably26,27

 

 

In-depth report

In-depth report supports clinical decision-making5

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.

1. Biomarker Findings

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

2. Genomic Findings

Clinically relevant alterations in 324 tested cancer-related genes

3. Pertinent negative results

Rules out important alterations that are not present


4. Therapies with clinical benefit

Approved targeted therapies (ranked alphabetically within NCCN therapy categories) for the patient's biomarker findings and genomic findings

5. Clinical trials

Relevant trials that your patient may be eligible for, based on their genomic profile and geographical location

6. Genomic findings with no reportable options

To help you rule out uncertainty and determine the most appropriate course of action

 

 

Impact of FoundationOne CDx

Opens up treatment possibilities

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

Key alterations in NSCLC

PCR-based (single gene, hotspot NGS) Assesses pre-specified region6,28 Detects limited number of alterations6,28 Low sensitivity for small insertions and deletions6,29 May require supplemental FISH9,28Comprehensive genomic profiling Detects all four classes of NSCLC clinically relevant alterations1,2,32,33FISH/IHC Detects rearrangements and copy number changes6,28 May miss rearrangements not known prior to testing30,31DeletionDeletionRearrangementPoint mutationAmplificationRearrangementMETBRAFALKEGFREGFRNTRKUp to 50% missed9Up to 50% missed9Up to 50% missed935% missed3083% missed2917% missed29Up to 50% missed9Class of genetic alterationEGFRΔ exon 19(743754)EGFRΔ exon 19(753761)ALKBRAFV600EMETNTRK17%35%83%50%Up to50%Up to50%Up to50%Up to

 

 

Efficient testing

Saves tissue and time

FoundationOne CDx delivers all insights at once in a single test, saving tissue and time.
Single biomarker testing FoundationOne CDx Biopsy Negative for tested biomarker Biopsy Delivers all insights at once Repeat testing Negative for tested biomarker Re-biopsy due to

 

 

Order

Order FoundationOne CDx

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.

References
  1. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
  2. FoundationOne®CDx Technical Specifications, 2019. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed July 2021).
  3. FoundationOne®CDx FDA Approval, 2017. Available at: 
    www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed July 2021).
  4. FoundationOne®CDx Clinical Validation, 2021. Available at: www.foundationmedicine.com/test/foundationone-cdx (Accessed July 2021)
  5. FoundationOne®CDx Sample Report. Available at: www.rochefoundationmedicine.com/F1CDxreport_TMBLung_RoW (Accessed July 2021).
  6. Drilon A et al. Clin Cancer Res 2015; 21: 3631–3639.
  7. Rankin A et al. Oncologist 2016; 21: 1306–1314.
  8. Ross JS et al. Cancer 2016; 122: 2654–2662.
  9. Suh JH et al. Oncologist 2016; 21: 684–691.
  10. Hirshfield KM et al. Oncologist 2016; 21: 1315–1325.
  11. Rozenblum AB et al. J Thorac Oncol 2017; 12: 258–268.
  12. Schwaederle M et al. Mol Cancer Ther 2016; 15: 743–752. 
  13. Wheler JJ et al. Cancer Res 2016; 76: 3690–3701. 
  14. Dhir M et al. Cancer Med 2017; 6: 195–206. 
  15. Zhao P et al. J Hematol Oncol 2019; 12: 54.
  16. Abida W et al. JAMA Oncol 2019; 5: 471–478.
  17. FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer. Available at: www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-first-line-treatment-msi-hdmmr-colorectal-cancer (Accessed July 2021).
  18. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2.2021, February 2021. Available at: www.nccn.org/professionals/physician_gls/pdf/prostate.pdf (Accessed July 2021)
  19. Kok M et al. ESMO Open 2019; 4(Suppl 2): e000511. 
  20. Gandara DR et al. Nat Med 2018; 24: 1441–1448.
  21. FDA approves pembrolizumab for adults and children with TMB-H solid tumors, 2020. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors (Accessed July 2021).
  22. Marabelle A et al. Ann Oncol. 2019;30(suppl_5):v475-v532.
  23. Yarchoan M et al. JCI Insight 2019; 4: e126908.
  24. Swisher EM et al. Lancet Oncol 2017; 18:75−87.
  25. Coleman RL et al. Lancet 2017; 390:1949−61.
  26. Merker JD et al. J Clin Oncol 2018; 36: 1631–1641.
  27. Scheerens H et al. Clin Transl Sci 2017; 10: 84–92.
  28. NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 5.2021, June 2021. Available at: www.nccn.org/professionals/physician_gls/pdf/nscl.pdf (Accessed July 2021).
  29. Schrock AB et al. Clin Cancer Res 2016; 22: 3281–3285.
  30. Ali SM et al. Oncologist 2016; 6: 762–770.
  31. Pekar-Zlotin M et al. Oncologist 2015; 20: 316–322.
  32. FoundationOne Liquid®CDx Technical Specifications, 2020. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed July 2021).
  33. Woodhouse R et al. PLoS One 2020; 15: e0237802