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.1–12 Comprehensive genomic profiling detects 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) and microsatellite instability (MSI).*1–6
What makes comprehensive genomic profiling different?
Multigene hotspot NGS tests
Comprehensive genomic profiling
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. 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.13
Validated and supported by clinical evidenceOur services are supported by a large and growing body of clinical evidence with over 200 publications since the founding of Foundation Medicine.14,15 The validation of Foundation Medicine’s comprehensive genomic profiling services is published in top-tier peer-reviewed journals.4–6
(predecessor to FoundationOne CDx)
Validation published in Nature Biotechnology 20134
Based on our analytically and clinically validated, FDA-approved comprehensive platform† 16,17
Validation published in Journal of Molecular Diagnostics 20185
Validation published in Blood 20166
*TMB reported in FoundationOne CDx and FoundationOne Heme. MSI reported in FoundationOne CDx, FoundationOne Liquid and FoundationOne Heme.
†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 Specifications available at: www.rochefoundationmedicine.com/f1cdxtech.
FDA, US Food and Drug Administration. MSI, microsatellite instability. NGS, next generation sequencing. TMB, tumour mutational burden.
- FoundationOne®CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed March 2019).
- FoundationOne®Liquid Technical Specifications, 2018. Available at: https://www.foundationmedicine.com/genomic-testing/foundation-one-liquid (Accessed March 2019).
- FoundationOne®Heme Technical Specifications, 2017. Available at: www.foundationmedicine.com/genomic-testing/foundation-one-heme (Accessed March 2019).
- Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
- Clark TA et al. J Mol Diagn 2018; 20: 686–702.
- He J et al. Blood 2016; 127: 3004–3014.
- Suh JH et al. Oncologist 2016; 21: 684–691.
- Chalmers ZR et al. Genome Med 2017; 9: 34.
- Rozenblum AB et al. J Thorac Oncol 2017; 12: 258–268.
- Schrock AB et al. Clin Cancer Res 2016; 22: 3281–3285.
- Ross JS et al. Gynecol Oncol 2013; 130: 554–559.
- Hall MJ et al. J Clin Oncol 2016; 34: 1523–1523.
- FoundationOne®CDx Sample Report, 2018. Available at: www.rochefoundationmedicine.com/reporting (Accessed March 2019).
- A search for “Foundation Medicine”[Affiliation] on the NCBI database resulted in 321 publications, as of October 2018. Available at: https://www.ncbi.nlm.nih.gov/pubmed/term=%E2%80%9CFoundation+Medicine%E2%80%9D%5BAffiliation%5D (Accessed March 2019).
- Foundation Medicine Publications. Available at: https://www.foundationmedicine.com/publications (Accessed March 2019).
- FoundationOne®CDx FDA Approval, 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed March 2019).
- FoundationOne®CDx clinical validation, 2017. Available at: http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx (Accessed March 2019).