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bTMB, blood mutational tumour burden; ctDNA: circulating tumour DNA; FDA: US Food and Drug Administration; MSI, microsatellite instability; TMB: tumour mutational burden. Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine®, Inc. Roche is the licensed distributor of Foundation Medicine® products outside of the United States.

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.

Base substitutions, insertions or deletions, copy number alterations and gene rearrangements.

§Based on a concordance study with FoundationOne®. FoundationOne CDx leverages the same comprehensive genomic profiling approach and is highly concordant with FoundationOne.

¥ Clinical validation based on 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: [XXXX].