A comprehensive approach to genomic profiling
The Roche Foundation Medicine CGP approach analyses the tumour genome to identify clinically relevant alterations and potentially expand patients’ treatment options.1–6,* Clinicians then receive clear, detailed information to inform the use of immunotherapies, identify other therapy options or identify trial opportunities.†7,8
FoundationOne® CDx offers opportunities for patients where there is uncertainty about the next clinical choice, helping to identify their personalised pathway. These results are evidence-based and validated, and thus further demonstrate Roche's continued vision and committment to personalised healthcare.1,9–11
Genomics vs genetics
What's the difference?
FoundationOne®: an established portfolio of genomic services
FoundationOne® CDx is a next-generation sequencing-based diagnostic test. The service provides access to the largest global molecular information currently available, analysing 324 known cancer‑relevant genes, across the four main classes of genomic alterations, in addition to tumour mutational burden and microsatellite instability, to inform treatment decision-making.8,17,18
Our established portfolio of services should be used proactively, at the first point of clinical uncertainty in any metastatic tumour to inform the use of immunotherapies, identify alternative therapy options or identify trial opportunities, to help optimise and personalise treatment strategies for patients in diverse clinical situations.2,5–7
Overview of services
FoundationOne® CDx informs a patient’s personalised pathway at the first point of clinical uncertainty.7,24,25
The combined strengths of both pharmaceuticals and diagnostics are putting Roche at the forefront of personalised healthcare.26
Our continuously growing genomic database, and ability to analyse and extract meaningful genomic information, is central to Roche's commitment to bringing about a new era of personalised healthcare in oncology.19,26 This individualised approach enhances the services provided by healthcare professionals and thus may have a positive impact on individual patient outcomes.26
- Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.26
- The combined strengths of both pharmaceuticals and diagnostics are putting Roche at the forefront of personalised healthcare.26
*CGP is a tumour testing method that utilises next-generation sequencing technology to identify all four classes of alterations (base substitutions, insertions or deletions, copy number alterations and gene rearrangements)1,7,8 across a large set of cancer-related genes (>50) known to drive cancer across tumour types.7,8 CGP is a ‘pan‑tumour’ approach, applicable for use across any type of cancer.1–6
†Therapies contained within the report may have been approved through a centralised EU procedure or a national procedure in an EU Member State (FoundationOne® CDx) or by the FDA (FoundationOne® Liquid).
§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. [RXUKRFMI00001e(2)] October 2018. Available to view here.
CGP: comprehensive genetic profiling; FDA: Food and Drug Administration.
RXUKRFMI00096 November 2019
- 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. RXUKRFMI00001e(2). October 2018.
- FoundationOne® Liquid Technical Specifications. RXUKRFMI00071. February 2019.
- Food and Drug Administration. Approved medical devices: FoundationOne® CDx. Available at: https://www.fda.gov/medical-devices/recently-approved-devices/foundationone-cdx-p170019
- A search for “Foundation Medicine”[Affiliation] on the NCBI database resulted in 413 results, as of July 2019. Available at: https://www.ncbi.nlm.nih.gov/pubmed/?term=%E2%80%9CFoundation+Medicine%E2%80%9D%5BAffiliation%5D
- Roche Foundation Medicine. Data on file. RXUKRFMI00117. July 2019
- National Human Genome Research Institute. Introduction to genomics. Available at: https://www.genome.gov/About-Genomics/Introduction-to-Genomics
- World Health Organization. Definitions of genetics and genomics. Available at: https://www.who.int/genomics/geneticsVSgenomics/en/
- Pao W, Hutchinson KE. Nat Med. 2012;18:349–351.
- Meldrum C, et al. Clin Biochem Rev. 2011;32:177–195.
- Schwaederle M, Kurzrock R. Oncoscience. 2015;2:779–780.
- Roche. RXUKRFMI00065. FoundationOne® CDx Gene List. October 2018.
- Chalmers ZR, et al. Genome Med. 2017;9:34.
- FoundationCore™. FoundationInsights™. Available at: https://www.foundationmedicine.com/insights-and-trials/foundation-insights
- Clark TA, et al. J Mol Diagn. 2018;20:686–702.
- Allen JM, et al. Clin Lung Cancer. 2017;18 :e219–e222.
- FoundationOne® Liquid Specimen Instructions. RXUKRFMI00080. November 2018.
- Roche. RXUKRFMI00091. FoundationOne® Liquid Gene List. February 2019.
- Rozenblum AB, et al. J Thorac Oncol. 2017;12:258–268.
- ASCO Post. Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available. April 2018. Available at: https://www.ascopost.com/News/58695
- Roche Media Release. Roche and Foundation Medicine reach definitive merger agreement to accelerate broad availability of comprehensive genomic profiling in oncology. Basel, 19 June 2018.
- Sun JX, et al. Cancer Res. 2018;78: Abstract 4757.