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A leading comprehensive genomic profiling approach

 

Our approach

Foundation Medicine approach broadly examines the tumour genome

The Foundation Medicine comprehensive genomic profiling approach* leverages next generation sequencing (NGS) technology to examine regions of the tumour genome that other tests miss.1-13 It detects both novel and known variants, including the four main classes of genomic alterations - base substitutions, insertions or deletions, copy number alterations and gene rearrangements - in a comprehensive set of cancer-relevant genes, and reports Tumour Mutational Burden (TMB) or blood Tumour Mutational Burden (bTMB), and Microsatellite Instability (MSl).†1-7

Multigene hotspot NGS tests

Multigene hotspot tests risk missing genomic alterations while comprehensive genomic profiling broadly analyses the genome to identify all relevant alterations

Comprehensive genomic profiling

Multigene hotspot tests risk missing genomic alterations while comprehensive genomic profiling broadly analyses the genome to identify all relevant alterations

*TMB reported by FoundationOne CDx and FoundationOne Heme. bTMB reported by FoundationOne Liquid CDx. MSI reported by FoundationOne CDx and FoundationOne Heme, MSI-H reported by FoundationOne Liquid CDx.

 

 

 

Clear in-depth reports

Clear, in-depth report supports clinical decision-making

Our clear, in-depth report supports clinical decision-making by providing insights on the patient's genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials. Approved therapies are ranked alphabetically within NCCN therapy categories (for additional information on the NCCN categories please refer to the NCCN Compendium® at www.nccn.org). Reports vary according to regional differences, e.g. EU reports list EU-approved therapy options to support clinical decision-making.‡14

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.14

When using different Foundation Medicine services across the patient journey, consistency of the reports aids comparison of the results.

1. Biomarker Findings

TMB/bTMB and MSI status, which may help inform immunotherapy treatment decisions

 

 

 

3. Clinical trials

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


2. Genomic Findings

Clinically relevant alterations in analysed cancer-related genes

 

 

 

4. Therapies with clinical benefit

Approved targeted therapies and immunotherapies (ranked alphabetically within NCCN therapy categories)§ for your patients Genomic Findings and Biomarker Findings

View a sample report:

 

 

 

Validation

Extensively validated and supported by clinical evidence

Our services are supported by a large and growing body of clinical evidence with over 500 publications since the founding of Foundation Medicine.15-16 The validations of Foundation Medicine's comprehensive genomic profiling services are published in top-tier peer-reviewed journals.4-7

*Comprehensive genomic profiling provides prognostic, diagnostic and predictive insights that inform treatment decisions for individual patients across all cancer types.

†TMB reported by FoundationOne CDx and FoundationOne Heme. bTMB reported by FoundationOne Liquid CDx. MSI reported by FoundationOne CDx and FoundationOne Heme, MSI-H reported by FoundationOne Liquid CDx.

‡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.

§For additional information on the NCCN categories please refer to the NCCN Compendium® (www.nccn.org).

¥Clinical validation demonstrated concordance with the following companion diagnostics: cobas® EGFR Mutation Test. Ventana ALK (DSF3) CDx Assay, Vysis ALK BreakApart FISH Probe Kit, therascreen® KRAS RGQ PCR Kit, Dako HER2 FISH PharmDx® Kit, cobas® BRAF V600 Mutation Test, THxlD® BRAF kit. For more information, please see the FoundationOne®CDx Technical Specifications available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine.

¶Clinical validation demonstrated concordance with the following diagnostics: cobas® EGFR Mutation Test v2, a tumor tissue polymerase chain reaction-based clinical trial assay (CTA), and an externally validated circulating cell-free DNA-based next-generation sequencing assay. For more information please see the FoundationOne Liquid®CDx Technical Specifications available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine.

bTMB, blood Mutational Tumour Burden; FDA, US Food and Drug Administration; MSI, Microsatellite Instability; NCCN, Nat ional Comprehensive Cancer Network; NGS, next generation sequencing; TMB, Tumour Mutational Burden.

References
  1. FoundationOne®CDx Technical Specifications, 2019. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed July 2021).
  2. FoundationOne Liquid®CDx Technical Specifications, 2020. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed July 2021).
  3. FoundationOne®Heme Specimen instructions, 2019. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed July 2021).
  4. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
  5. Woodhouse R et al. PLoS One 2020; 15: e0237802
  6. Clark TA et al. J Mol Diagn 2018; 20: 686–702.
  7. He J et al. Blood 2016; 127: 3004–3014.
  8. Suh JH et al. Oncologist 2016; 21: 684–691.
  9. Chalmers ZR et al. Genome Med 2017; 9: 34.
  10. Rozenblum AB et al. J Thorac Oncol 2017; 12: 258–268.
  11. Schrock AB et al. Clin Cancer Res 2016; 22: 3281–3285.
  12. Ross JS et al. Gynecol Oncol 2013; 130: 554–559.
  13. Hall MJ et al. J Clin Oncol 2016; 34: 1523–1523
  14. FoundationOne®CDx Sample Report. Available at: www.rochefoundationmedicine.com/F1CDxreport_TMBLung_RoW (Accessed July 2021).
  15. A search for "Foundation Medicine"[Affiliation] on the NCBI database resulted in 518 publications, as of April 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/?term=%22Foundation+Medicine%22%5BAffiliation%5D (Accessed August 2020)
  16. Foundation Medicine. Available at: www.foundationmedicine.com (Accessed July 2021)
  17. FoundationOne®CDx FDA Approval, 2017. Available at: 
    www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed July 2021).
  18. FoundationOne®CDx Clinical Validation, 2021. Available at: www.foundationmedicine.com/test/foundationone-cdx (Accessed July 2021).
  19. FoundationOne Liquid CDx FDA Approval, 2020. Available at: www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721 (Accessed July 2021).