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What is Precision Medicine? Comprehensive genomic profiling
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FoundationOne®
offers comprehensive
genomic profiling

Our approach

Our approach is designed to improve testing efficiency when compared with multiple, single-biomarker tests1

The Roche Foundation Medicine platform leverages next-generation sequencing (NGS) technology to examine regions of the tumour genome that common diagnostic techniques such as PCR/IHC/FISH, and multigene hotspot NGS tests may miss.2–11 Comprehensive genomic profiling (CGP) detects the four main classes of genomic alterations–base substitutions, insertions and deletions, copy number alterations and gene rearrangements–in a comprehensive set of over 300 cancer‑relevant genes, and reports tumour mutational burden (TMB) and microsatellite instability (MSI).*2,6,7,12,13–17

How is CGP different to existing diagnostic tests?

Multigene hotspot NGS tests

Multigene hotspot tests risk missing genomic alterations while comprehensive genomic profiling broadly analyses the genome to identify all relevant alterations

Comprehensive genomic profiling

Multigene hotspot tests risk missing genomic alterations while comprehensive genomic profiling broadly analyses the genome to identify all relevant alterations
Clear in-depth reports

The FoundationOne® report provides clear, detailed information to support treatment
decision-making†2,9,11,17

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 Roche Foundation Medicine report (FoundationOne CDx) may also highlight important disease-relevant genes that have no alterations but are particularly relevant for the specific tumour type,17 and identify approved targeted therapies, which are constantly assessed and monitored for safety and efficacy.18,19

Detailed patient profile reports2,9,11,17

Ultimately the decision as to what is the most appropriate course of treatment for the patient resides entirely within the discretion of the treating physician. Decisions on patient care and treatment must be based on the independent medical judgment of the treating physician, taking into consideration all applicable information concerning the patient’s individual situation in accordance with the standard of care in a given community. A treating physician’s decisions should not be based on a single test, such as this test, or the information contained in this report. Certain sample or variant characteristics may result in reduced sensitivity.

To view a sample report, please contact the team at Roche Foundation Medicine by clicking here.

Validation

Quality and validation of evidence with FoundationOne® CDx and FoundationOne® Liquid CDx aims to provide service confidence

FoundationOne® CDx and FoundationOne® Liquid CDx have been approved as a companion diagnostic by the FDA. Foundation Medicine also features in over 750 publications in peer-reviewed journals.20,21 The information provided in the report is reliable, accurate and validated clinically and analytically.

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.22–24 Clinical validation is the ability to divide one population into two or more groups on the basis of outcomes, such as treatment response.22–24

V a l i d a t i o n p u b l i s h e d i n N a t u r e B i o t e c h n o l o g y 2 0 1 3 2 and Plos One 2 0 2 2 V a l i d a t i o n p u b l i s h e d i n Plos One 2 0 2 0 11 17 P a p e r p u b l i s h e d i n Blood 2 0 1 6 9 I t h a s n o t b e e n c l e a r e d o r a p p r o v e d b y t h e F D A . HEME

*TMB and MSI reported in FoundationOne® CDx and FoundationOne® HEME. FoundationOne® Liquid CDx reports blood TMB, MSI-high and tumour fraction.

†Therapies contained in the report may have been approved through a centralised EU procedure or a national procedure in an EU Member State.

For more information, please see the FoundationOne® CDx Technical Specifications and the FoundationOne® Liquid CDx  Technical Specifications and FoundationOne® HEME Technical Specifications

CGP: comprehensive genomic profiling; EMA: European Medicines Agency; FISH: fluorescence in situ hybridisation; IHC: immunohistochemistry; MSI: microsatellite instability;  NGS: next-generation sequencing; PCR: polymerase chain reaction; TMB: tumour mutational burden.

M-GB-00009116 April 2023

References

  1. Munoz J, et al. Am Soc Oncol Educ Book. 2013;127–134.
  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. Schrock AB, et al. Clin Cancer Res. 2016;22:3281–3285.
  9. He J, et al. Blood. 2016;127:3004–3014.
  10. Rozenblum AB, et al. J Thorac Oncol. 2017;12:258–268.
  11. Woodhouse R et al. Plos One Sept 2020.
  12. Cheng DT, et al. J Mol Diagn. 2015;17:251–264.
  13. Le DT, et al. N Engl J Med. 2015;372:2509–2520.
  14. Rizvi NA, et al. Science. 2015;348:124–128.
  15. Chalmers ZR, et al. Genome Med. 2017;9:34.
  16. Hall MJ, et al. J Clin Oncol. 2016;30(15_suppl):1523.
  17. Milbury CA et al. PLoS One. 2022;17(3):e0264138.
  18. FoundationOne® Liquid CDx Technical Specifications.
  19. European Medicines Agency. Authorisation of medicines. 2018. Available at: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines.
  20. 796 results, as of October 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/?term=%22Foundation+Medicine%22+%5BAffiliation%5D.
  21. Food and Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available at https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.
  22. Merker JD, et al. J Clin Oncol. 2018;36:1631–1641.
  23. Scheerens H, et al. Clin Transl Sci. 2017;10:84–92.
  24. Masucci GV, et al. J Immunother Cancer. 2016;4:76.
  25. Milbury CA et al. PLoS One. 2022;17(3):e0264138. doi: 10.1371/journal.pone.0264138.