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New: Introducing our new FDA-validated FoundationOne® Liquid CDx liquid biopsy*

Like every person living with cancer, every tumour is unique. Our established portfolio includes comprehensive genomic profiling (CGP)* for metastatic solid tumours and haematological malignancies to help you choose tailored treatment strategies for your patients.1

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.2–7,* Clinicians then receive clear, detailed information to inform the use of immunotherapies, identify other targeted therapy options or identify trial opportunities.†8,9

FoundationOne® 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.1,2,10–11

Insertions and deletions GENOMIC ALTERATIONS
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FoundationOne®: an established portfolio of genomic services

FoundationOne® CDx and FoundationOne® Liquid CDx are next generation sequencing-based diagnostic tests. 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.8,9,17

Our established portfolio of services should be used proactively, at the first point of clinical uncertainty in any tumour to inform the use of immunotherapies, identify alternative targeted therapy options or identify trial opportunities, to help optimise and personalise treatment strategies for patients in diverse clinical situations.3,6–8

06_foundationOne CDx_03_genes and biomarkers_v2MSITMBBase substitutionsTumour mutationalburdenMicrosatellite instabilityRearrangementsAnalyses324known cancer-relevant genes

Overview of services

8 9 §1,2 1 , 9 , 1 1 9 3 , 6 , 7 20 20 8 19

If you require details around the certifications for these products, please submit a request to Medical Information on
0800 328 1629 or by email at medinfo.uk@roche.com 
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Genomics vs genetics

What's the difference?

Genetics The study of genes and their role in inheritance 12,13 Genomics The study of all of one person’s genes and their functions 12,13

The main difference between the two terms is that genetics focuses on single genes, whereas genomics assesses all the genes together, and how they interact with each other to influence the growth and development of cells.12,13 Genetic testing can help to provide a risk assessment for the patient by predicting the chance of developing a specific disorder or how a patient may react to a certain medication.12 As our knowledge increases around the specific genomic alterations in cancer, treatment options can now be more personalised based on the assessment of molecular alterations identified from a specific tumour.12-16

FoundationOne® CDx informs a patient’s personalised pathway at the first point of clinical uncertainty.8,23,24

Combined commitment

The combined strengths of both pharmaceuticals and diagnostics are putting Roche at the forefront of personalised healthcare.23

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.18,23 This individualised approach enhances the services provided by healthcare professionals and thus may have a positive impact on individual patient outcomes.23

  • Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.22-25
Oncology Molecular insights Precisionmedicine The Foundation Medicine platform has been analytically validated, with high sensitivity and specificity scores, to ensure genomic alterations are identified accurately and methodically, providing you with detailed information to support confident clinical decision-making 1,2,8,9,11 Roche is spearheading the next generation of healthcare with partners around the globe. Our vision is to ensure that the screening, diagnosis, treatment and even prevention of diseases will more quickly and effectively transform the lives of people everywhere The right treatment for the right patient at the right time
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*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)2,8,9 across a large set of cancer-related genes known to drive cancer across tumour types.8,9 CGP is a ‘pan‑tumour’ approach, applicable for use across any type of cancer.2–7

†Therapies contained within 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, FoundationFocus CDx BRCA.1

CGP: comprehensive genomic profiling; FDA: Food and Drug Administration.

M-GB-00005288 May 2022

References

  1. https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools 
  2. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.
  3. Drilon A et al. Clin Cancer Res 2015; 21: 3631–3639.
  4. Rankin A et al. Oncologist 2016; 21: 1306–1314.
  5. Ross JS et al. Cancer 2016; 122: 2654–2662.
  6. Suh JH et al. Oncologist 2016; 21: 684–691.
  7. Hirshfield KM et al. Oncologist 2016; 21: 1315–1325.
  8. FoundationOne® CDx Technical Specifications.
  9. FoundationOne® Liquid CDx Technical Specifications.
  10. Available at: A search for 'Foundation Medicine' on the NCBI database resulted in. https://pubmed.ncbi.nlm.nih.gov/?term=%22Foundation+Medicine%22+%5BAffiliation%5D 
  11. Woodhouse R.et al.Plos One. September 25, 2020
  12. https://www.genome.gov/about-genomics/fact-sheets/Genetics-vs-Genomics
  13. Available at: World Health Organisation definition of genetics and genomics
  14. Pao W, Hutchinson KE. Nat Med. 2012;18:349–351.
  15. Meldrum C, et al. Clin Biochem Rev. 2011;32:177–195.
  16. Schwaederle M, Kurzrock R. Oncoscience. 2015;2:779–780.
  17. Chalmers ZR, et al. Genome Med. 2017;9:34.
  18. Available at https://www.foundationmedicine.com/service/genomic-data-solutions.
  19. FoundationOne® CDx Specimen Instructions
  20. FoundationOne® Liquid CDx Specimen Instructions
  21. Rozenblum AB, et al. J Thorac Oncol. 2017;12:258–268.
  22. ASCO Post. Comprehensive Genomic-Profiling assay FoundationOne® CDx is commercially available April 2018. Available at https://www.ascopost.com/news/58695
  23. 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.
  24. Sun JX, et al. Cancer Res. 2018;78: Abstract 4757.