Our approach is designed to improve operation efficiency when compared with multiple, narrower tests1
The Roche Foundation Medicine platform leverages NGS technology to examine regions of the tumour genome, which common diagnostic techniques such as PCR/IHC/FISH, and multigene hotspot NGS tests may miss.2–11 CGP detects the four main classes of genomic alterations – base substitutions, insertions or deletions, copy number alterations and gene rearrangements – in a comprehensive set of over 300 cancer‑relevant genes, and reports TMB and MSI.*2,6,7,12,13–16
How is CGP different to existing diagnostic tests?
Multigene hotspot NGS tests
Comprehensive genomic profiling
Clear in-depth reports
The FoundationOne® report provides clear, detailed information to support treatment decision-making†17
Our clear, detailed report supports clinical decision-making by providing insights into the patient’s genomic profile and using these to inform the use of immunotherapies, identify alternative therapy options and identify trial opportunities. The FoundationOne® CDx report may also highlight important disease-relevant genes that have no alterations but are particularly relevant for the specific tumour type,17 and identify European Medicines Agency (EMA)‑validated therapies,17† which have been assessed and authorised before being made available to patients.18
Quality and validation of evidence with FoundationOne® CDx aims to provide service confidence
FoundationOne® CDx has been approved as a companion diagnostic by the FDA for 17 different therapies, as well as featuring in over 250 publications in peer-reviewed journals.19,20 This level of validation should provide confidence that the information you are acting upon is well-informed, accurate and reliable.
All services are analytically and clinically validated
All testing procedures should be validated prior to being introduced into routine clinical care. Analytical validation is the ability to detect and measure the presence of a specific biomarker of interest with high sensitivity, accuracy and robustness.21–23 Clinical validation is the ability to divide one population into two or more groups on the basis of outcomes, such as treatment response.21–23
*TMB and MSI reported in FoundationOne® CDx and FoundationOne® Liquid CDx.
†Therapies contained in the report may have been approved through a centralised EU procedure or a national procedure in an EU Member State.
‡ Analytical 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 [Hyperlink to CDx Tech Specs] and the FoundationOne® Liquid CDx Technical Specifications [Hyperlink to Liquid Tech Specs].
CGP: comprehensive genomic profiling; EMA: European Medicines Agency; FISH: fluorescence in situ hybridisation; IHC: immunohistochemistry; MAF: mutant allele fraction; MSI: microsatellite instability; NCCN: National Comprehensive Cancer Network; NGS: next-generation sequencing; NHS: National Health Service; PCR: polymerase chain reaction; TMB: tumour mutational burden.
M-GB-00001593 September 2020
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