Frequently asked questions

How does FoundationOne work?

A patient’s FoundationOne report is a molecular profile of genomic alterations with potential therapeutic options

FoundationOne uses comprehensive and validated techniques to examine over 99% of the coding sequence of 315 cancer-related genes plus select introns from 28 other genes, using hybrid capture-based next-generation sequencing (NGS).1,2 FoundationOne also detects tumour mutational burden and microsatellite instability, which have been associated with the potential efficacy of some immunotherapies.3–6

By detecting genomic alterations that may be missed by others, FoundationOne helps to provide peace of mind in the knowledge that the potential to find relevant treatment options is maximised.1,3,7–9

How might FoundationOne be useful in clinical practice?
FoundationOne can identify clinically relevant alterations missed by other testing options. This information can then be used by the physician when considering the most appropriate treatment, including options that might not have been otherwise considered, such as therapies currently in clinical trials.1,3,7–9
Who is eligible for FoundationOne?
FoundationOne is suitable for anyone with a recurrent or metastatic solid tumour cancer. The benefits of using FoundationOne have been studied mostly in people with advanced disease.1,3,10–12
How to order FoundationOne?

FoundationOne has a straightforward ordering process that is powered by a global team of experts who help to assess, advise and support.

Please visit our Order page to download the forms and get started today.

What type of tissue sample is needed for FoundationOne?

FoundationOne requires:

·      ≥40µm of formalin-fixed paraffin-embedded tissue, including core needle biopsies, fine-needle aspirates and effusion cytologies, of which ~20% or more is of malignant origin, on 8 to 10 unstained slides or from a block reviewed and approved by a pathologist as the most representative block for the diagnosis13

·      All solid tumour types are acceptable13

Download detailed specimen requirements

Foundation Medicine is able to process any clinical sample that meets these guidelines. Should the sample be insufficient, notification will be provided within approximately two days of receipt. However, in some circumstances, a qualified report may be issued.1,13

How long does it take to get the results?

The report will be issued 11–14 days after receipt of the sample and all necessary documentation at our laboratory.1

It is important to provide an appropriate sample and all necessary documentation in order to ensure the sample can be processed in the laboratory.  This includes:

[Local markets to confirm details]

Please note that the above estimate does not include the time taken to retrieve and send the sample and all necessary documentation to Foundation Medicine.1

How are the results delivered?

Results will be sent via e-mail approximately 11–14 days after the sample and all necessary documentation are received. 1

[Local markets to provide details]

How much does FoundationOne cost?

For information on the cost of profiling with FoundationOne, please contact customer services:

Email:           [Local countries to provide details]

Telephone:    [Local countries to provide details]

The cost of profiling with FoundationOne also includes shipping fees for both delivery and return of samples (upon request), as well as continued access to our customer services team. 

Do these tests predict response to chemotherapy or the likelihood of recurrence?
These tests are not designed to predict response to chemotherapy or recurrence of disease. They help to match the genomic alterations present in a cancer with specific targeted and immunotherapies either approved, launched or being investigated in clinical trials.3,14
  1. FoundationOne technical information.
  2. Frampton, GM et al. Nat Biotechnol 2013; 31:1023–1031
  3. Rozenblum AB et al. J Thorac Oncol 2017; 2:258–268 (and supplementary material).
  4. Masucci GV et al. Int J Immunother Cancer Res 2016; 4:16.
  5. Chalmers ZR et al. Genome Med 2017; 9:34.
  6. Castro MP et al. J. Immunother 2015; 3:58.
  7. Ali SM et al. Oncologist 2016; 6:762–670.
  8. Schrock AB et al. Clin Cancer Res 2016; 13:3281–3285.
  9. Chmielecki J et al. Oncologist 2015; 20:7–12.
  10. Ross JS et al. JAMA Oncol 2015; 1:40–49.
  11. Ross JS et al. Cancer 2016; 17:2654–2562.
  12. Drilon A et al. Clin Cancer Res 2015; 16:3631–3639.
  13. FoundationOne specimen guidelines
  14. Schwaederle M et al. Mol Cancer Ther 2015; 14:1488–1494.