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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

What is FoundationOne®CDx?

RFMI_F1LCDx launch_Blueprint EU_image 7 editable LT Delivers all insights at once in a single test, thus saving tissue and time versus sequential biomarker testing 1,2,6 Provides insights that can help support treatment decisions and may improve clinical outcomes ¥2,11–14 Potentially expands your patients treatment options ¥1,6–10 Reports vary according to regional differences, e.g. EU reports list EU-approved therapy options to support clinical decision-making §5 Clear, in-depth report provides insights on the genomic profile of your patient as well as associated targeted therapies, immunotherapies (ranked alphabetically within NCCN therapy categories) and relevant clinical trials 5 Based on our analytically and clinically validated, FDA-approved comprehensive platform† 3,4 Assesses the four main classes of genomic alterations* in 324 cancer-relevant genes and reports TMB, MSI and LoH 1,2 A single, tissue- and time-saving test Opens possibilities EU report Supports clinical decision-making Extensively validated 324 genes, TMB, MSI and LoH FDA
Genes and genomic signatures

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

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

EU report includes EU-approved therapies to support clinical decision-making§5

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.

223156Genomic signaturesTMB and MSI status, which may help predict response to immunotherapy, as well as LoH status, which may help inform the use ofPARP inhibitorsPertinent negative resultsRules out important alterations that are not presentGene alterationsClinically relevant alterations in 324 tested cancer-related genesTherapies with clinical benefitApproved targeted therapies (ranked alphabetically within NCCN therapy categories)for the patients genomic signatures and gene alterations134Clinical trialsRelevant trials that your patient may be eligible for, based on their genomic profile and geographical locationGenomic findings with no reportable optionsTo help you rule out uncertainty and determine the most appropriate course of action564

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
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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 eligibi lity 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.

References
  1. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
  2. FoundationOne®CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed August 2020).
  3. FoundationOne®CDx FDA Approval, 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed August 2020).
  4. FoundationOne®CDx clinical validation, 2017. Available at: http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx (Accessed August 2020).
  5. FoundationOne®CDx Sample Report. Available at: https://www.foundationmedicine.nl/content/dam/rfm/sample-reports/f1cdx/eu_version_-_ema_without_page_1/F1CDx%20EU%20Sample%20Report%20(Lung).pdf (Accessed August 2020).
  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 August 2020).
  18. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2.2020, May 2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf (Accessed August 2020).
  19. Kok M et al. ESMO Open 2019; 4(Suppl 2): e000511.
  20. Gandara DR et alNat 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 August 2020).
  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 6.2020, June 2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf (Accessed August 2020).
  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. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020. Available at: http://www.eifu.online/FMI/190070862 (Accessed August 2020).
  33. Data on file: Clinical and analytical validation data file for FoundationOne Liquid CDx.