A comprehensive approach to genomic profiling
The Foundation Medicine comprehensive genomic profiling approach broadly analyses the tumour genome to identify clinically relevant alterations and potentially expand patients’ treatment options.*1–5 Clinicians then receive a clear, in-depth report that supports clinical decision-making by providing insights on the patient’s genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials.11
A high-quality portfolio of services
Our high-quality portfolio of services helps optimise and personalise treatment strategies for patients in diverse clinical situations.7–9
Overview of services
*Comprehensive genomic profiling is a tumour testing method that utilises next-generation sequencing technology to identify all four classes of alterations across a large set of cancer-related genes (>50) known to drive cancer across tumour types. Comprehensive genomic profiling is a ‘pan-tumour’ approach, or applicable for use across any type of cancer.
†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. FFPE, formalin-fixed paraffin-embedded.
- Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
- Drilon A et al. Clin Cancer Res 2015; 21: 3631–3639.
- Rankin A et al. Oncologist 2016; 21: 1306–1314.
- Ross JS et al. Cancer 2016; 122: 2654–2662.
- Suh JH et al. Oncologist 2016; 21: 684–691.
- Hirshfield KM et al. Oncologist 2016; 21: 1315–1325.
- 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).
- FoundationOne®CDx FDA Approval, 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed March 2019).
- FoundationOne®CDx Sample Report, 2018. Available at: www.rochefoundationmedicine.com/reporting (Accessed March 2019).
- FoundationOne®CDx FDA Approval Press Release, 2017. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587273.htm (Accessed March 2019).
- Clark TA et al. J Mol Diagn 2018; 20: 686–702.
- Roche Media Release, 2018. Available at: https://www.roche.com/media/releases/med-cor-2018-06-19.htm (Accessed March 2019).