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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

A single, tissue- and time-saving test Delivers all insights at oncein a single test, thus saving tissue and time versus sequential biomarker testing1,2,6Supports clinical decision-makingClear, 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 trials5FDA
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.24,2S

Tumour mutational burdenBase SubstitutionsInsertions and deletionsCopy number alterationsRearrangementsMicrosatellite instabilityMSILoHTMBAnalyses324known cancer-relevant genes
FoundationOne CDx gene list FoundationOne CDx gene list
View FoundationOne CDx Technical Specifications View FoundationOne CDx Technical Specifications
Learn more about comprehensive genomic profiling Learn more about comprehensive genomic profiling

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
Learn more about the impact of FoundationOne CDx Learn more about the impact of FoundationOne CDx
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.

FoundationOne CDx sample report FoundationOne CDx sample report

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(743–754)EGFRΔ exon 19(753–761)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
Ordering

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 eligibi lity for several immunotherapies across many different cancer types.

Order Order
View FoundationOne CDx Specimen Instructions View FoundationOne CDx Specimen Instructions
View FoundationOne CDx Technical Specifications View FoundationOne CDx Technical Specifications
Any questions? Any questions?

*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. 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. Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing. Nat Biotechnol; 31: 1023–1031. 2013
  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. Broad, Hybrid Capture–Based Next-Generation Sequencing Identifies Actionable Genomic Alterations in Lung Adenocarcinomas Otherwise Negative for Such Alterations by Other Genomic Testing Approaches. Clin Cancer Res ; 21: 3631–3639. 2015
  7. Rankin A et al. Broad Detection of Alterations Predicted to Confer Lack of Benefit From EGFR Antibodies or Sensitivity to Targeted Therapy in Advanced Colorectal Cancer. Oncologist ; 21: 1306–1314. 2016
  8. Ross JS et al. Nonamplification ERBB2 genomic alterations in 5605 cases of recurrent and metastatic breast cancer: An emerging opportunity for anti-HER2 targeted therapies. Cancer; 122: 2654–2662. 2016
  9. Suh JH et al. Comprehensive Genomic Profiling Facilitates Implementation of the National Comprehensive Cancer Network Guidelines for Lung Cancer Biomarker Testing and Identifies Patients Who May Benefit From Enrollment in Mechanism-Driven Clinical Trials. Oncologist ; 21: 684–691. 2016
  10. Hirshfield KM et al. Clinical Actionability of Comprehensive Genomic Profiling for Management of Rare or Refractory Cancers. Oncologist ; 21: 1315–1325. 2016
  11. Rozenblum AB et al. Clinical Impact of Hybrid Capture-Based Next-Generation Sequencing on Changes in Treatment Decisions in Lung Cancer. J Thorac Oncol; 12: 258–268. 2017
  12. Schwaederle M et al. Precision Oncology: The UC San Diego Moores Cancer Center PREDICT Experience. Mol Cancer Ther; 15: 743–752. 2016
  13. Wheler JJ et al. Cancer Therapy Directed by Comprehensive Genomic Profiling: A Single Center Study. Cancer Res; 76: 3690–3701. 2016
  14. Dhir M et al.Impact of genomic profiling on the treatment and outcomes of patients with advanced gastrointestinal malignancies. Cancer Med; 6: 195–206. 2017
  15. Zhao P et al. Mismatch repair deficiency/microsatellite instability-high as a predictor for anti-PD-1/PD-L1 immunotherapy efficacy. J Hematol Oncol; 12: 54. 2019
  16. Abida W et al. Analysis of the Prevalence of Microsatellite Instability in Prostate Cancer and Response to Immune Checkpoint Blockade. JAMA Oncol; 5: 471–478. 2019
  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. How I treat MSI cancers with advanced disease. ESMO Open; 4(Suppl 2): e000511. 2019
  20. Gandara DR et al. Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab. Nat Med; 24: 1441–1448. 2018
  21. 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).
  22. Marabelle A et al. Association of tumor mutational burden with outcomes in patients with select advanced solid tumors treated with pembrolizumab in KEYNOTE-158. Ann Oncol.;30(suppl_5):v475-v532. 2019
  23. Yarchoan M et al. PD-L1 expression and tumor mutational burden are independent biomarkers in most cancers. JCI Insight; 4: e126908. 2019
  24. Swisher EM et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol; 18:75−87. 2018
  25. Coleman RL et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet; 390:1949−61.2017
  26. Merker JD et al. Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review. J Clin Oncol; 36: 1631–1641. 2018
  27. Scheerens H et al. Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch. Clin Transl Sci; 10: 84–92. 2017
  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. Comprehensive Genomic Profiling Identifies Frequent Drug-Sensitive EGFR Exon 19 Deletions in NSCLC not Identified by Prior Molecular Testing. Clin Cancer Res; 22: 3281–3285. 2016
  30. Ali SM et al. Comprehensive Genomic Profiling Identifies a Subset of Crizotinib-Responsive ALK-Rearranged Non-Small Cell Lung Cancer Not Detected by Fluorescence In Situ Hybridization. Oncologist; 6: 762–770. 2016
  31. Pekar-Zlotin M et al. Fluorescence in situ hybridization, immunohistochemistry, and next-generation sequencing for detection of EML4-ALK rearrangement in lung cancer. Oncologist; 20: 316–322. 2015
  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.