*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, National Comprehensive Cancer Network; NGS, next generation sequencing; TMB, Tumour Mutational Burden.
- FoundationOne®CDx Technical Specifications, 2022. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed September 2023).
- FoundationOne Liquid®CDx Technical Specifications, 2022. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed September 2023).
- FoundationOne®Heme Specimen instructions, 2022. Available at: www.foundationmedicine.qarad.eifu.online/foundationmedicine/en/foundationmedicine (Accessed September 2023).
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- FoundationOne®CDx Sample Report. Available at: www.rochefoundationmedicine.com/F1CDxreport_TMBLung_RoW (Accessed July 2021).
- 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)
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- FoundationOne®CDx FDA Approval, 2017. Available at:
www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed July 2021). - FoundationOne®CDx Clinical Validation, 2021. Available at: www.foundationmedicine.com/test/foundationone-cdx (Accessed July 2021).
- FoundationOne Liquid CDx FDA Approval, 2020. Available at: www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721 (Accessed July 2021).