FoundationOne®

About Genomic Profiling

What is FoundationOne®?

FoundationOne provides a comprehensive genomic profile to identify molecular alterations in a patient's cancer and match them with targeted therapies and clinical trials to support decision making by multi-disciplinary teams.

Who is it suitable for?

Who is eligible for the FoundationOne tumour profiling service?

FoundationOne is suitable for most patients with malignant solid tumour cancers.

It is most frequently used in patients with advanced, recurrent and / or metastatic cancers who have exhausted standard of care treatment options.

FoundationOne reports reveal clinically relevant alterations in tumour DNA which are associated with the effect of targeted cancer treatments either documented in the existing clinical literature or which are being explored in clinical studies.

This service is not designed to predict response to chemotherapy or recurrence.

Ordering Foundation One

How the process works:

  • The oncologist orders FoundationOne from Roche
  • The pathologist prepares tumour sample
  • Pathologist sends the sample to Foundation Medicine Inc.
  • Foundation Medicine analyse the tumour sample and produce a clinical report containing the results
  • The clinical report is sent from Foundation Medicine to the oncologist via a secure portal

For Oncologists

Getting started:

Please download the Order Form, complete all of the information requested.
Sign and send with a valid Purchase Order from your organisation to
welwyn.foundationmedicine_custcare@roche.com or freefax
0800 917 8307.

You will be required to confirm that you will either (i) use the Informed Consent Form provided or (ii) warrant
that existing consent form(s) appropriately obtain the consent as detailed in our Informed Consent Form, with particular
regard to the exchange of personal and/or sensitive personal data beyond the EU and/or EEA.

Do not send the Informed Consent Form to Roche or Foundation Medicine

Download Order & Informed
Consent Form


Download link to pathology and Oncology information pack




Your next steps

For Pathologists

Getting started

FoundationOne requires 40\0x03BCm of FFPE tissue, 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 patient diagnosis. All solid tumour types are acceptable.

Foundation Medicine is able to process any clinical sample that meets these guidelines.
Should your sample be insufficient, you will be notified as soon as possible following reciept.

If you have a question about the order process, collection or the status of your order,
please contact the Roche Foundation Medicine Customer Care team on
0800 731 5711 or by e-mail welwyn.foundationmedicine_custcare@roche.com.

If you have a question about the sample please contact the Medical Information team on
0800 328 1629 or email medinfo.uk@roche.com.



Your next steps

Learn more

FAQ

For Healthcare Professionals

  • Who is eligible for the FoundationOne service?

    FoundationOne is suitable for most patients with malignant solid tumour cancers.

    It is most frequently used in patients with advanced, recurrent and / or metastatic cancers who have exhausted standard of care treatment options.

    FoundationOne reports reveal clinically relevant alterations in tumour DNA which are associated with the effect of targeted cancer treatments either documented in the existing clinical literature or which are being explored in clinical studies.

  • What are the specimen requirements for FoundationOne?

    FoundationOne requires 40 \0x03BCm of FFPE tissue, 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 patient diagnosis. All solid tumour types are acceptable. Click here to download detailed specimen guidelines.

    Foundation Medicine is able to process any clinical sample that meets these guidelines. Should your sample be in sufficient or unsatisfactory you will be notified as soon as possible following reciept.

  • How long does it take to get results?

    The ordering Oncologist will receive a report approximately 11 to 14 days after Foundation Medicine receives a satisfactory tissue sample.

  • How do I obtain the results?

    We will send the results via your FoundationICE account.

    You are solely responsible for any and all action(s) undertaken as a result of the information provided in the Foundation One and/or Foundation One Heme report(s) (“Report”) and Roche does not seek to recommend any particular medication(s) referred therein. It is your responsibility to evaluate and interpret the information provided in the Report, along with all other available clinical information regarding your patient, in order to determine the best treatment decision(s) in your own independent medical judgment, and as far as possible in collaboration with other healthcare professionals involved in the care of your patient.

  • Does this service predict response to chemotherapy or the likelihood of recurrence?

    No, this service is not designed to predict response to chemotherapy or recurrence. They help match the genomic alterations present in a tumour with specific targeted therapies or clinical trials.

  • What information does the FoundationOne service provide?

    FoundationOne may identify an "actionable" mutation(s) helping:
    1. Identify an FDA approved therapy for the patients tumour type and shown to target one or more of the genomic alterations found by the service,

    2. Identify an FDA approved therapy in another tumour type and shown to target one or more of the genomic alterations found by the service, or

    3. Identify clinical trials of a licensed or experimental treatment which may work by targeting an alteration found by the service or a relevant pathway.

  • Will another biopsy need to be taken for the service?

    A recent sample of a patient’s tumour is preferred as genomic alterations are known to change over time and with treatment. The service can be run on a tissue sample from an earlier biopsy of either the primary tumour or cancer cells that have spread to other parts of the body. If there is not enough tissue remaining from an earlier biopsy to run the service an additional biopsy may need to be collected. It may be required to take a new biopsy to get a more recent sample.

  • Does it matter what kind of cancer a patient presents with or how advanced the cancer is?

    FoundationOne is designed to any type of tumour regardless of where it is found in the body or how advanced the cancer. However, the service is generally used for more advanced disease or disease that has spread.

  • Are the results intended to provide information on both hereditary and acquired genomic alterations found in an individual’s tumour?

    The results will provide information on any acquired genomic alterations found in a patients tumour but are not intended to provide information on inherited genetic alterations. It is important to remember that only 5-10 percent of cancers are caused by hereditary alterations. However, since these alterations can be inherited by multiple family members and passed down from generation to generation, information about inherited alterations affects entire families, raising personal and ethical considerations that factor into the decision to receive that information. FoundationOne is not a service for inherited alterations.

  • What are the limitations of the service?

    In about 15-20 percent of cases, FoundationOne results don't identify an actionable genomic alteration, meaning there are no approved treatments or therapies in clinical trials that have been shown to be effective against the alterations found in a patient’s tumour. Additionally, there may be obstacles to obtaining therapy in cases where the service finds actionable alterations. For example, if the therapy has been approved in a different tumour type, there may be no reimbursement for the cost of that treatment for an unapproved tumour type. It is also possible that a patient may not be eligible for, or able to enroll in an ongoing clinical trial of a therapy targeted against an alteration found by the service.

    It is important to understand that while the service often provides valuable information to help healthcare professionals make the best possible decisions about treatment, there is no guarantee that the treatment identified will work for the patient. While significant progress has been made in treatments targeting the underlying genomic alterations that cause cancer, cancer is a complex disease driven by multiple factors, no therapy is 100 percent effective and responses to therapies vary.

About FoundationMedicine

About FoundationMedicine

We are a passionate group of experts in genome technology, cancer biology, clinical oncology and information science. We are also supported by leaders in business development and commercialisation.

Foundation Medicine Vision:

Foundation Medicine is leading a transformation in cancer care, where each patient’s treatment is informed by a deep understanding of the molecular changes that contribute to their disease.

Roche Products Limited is the sole distributor for the Services of Foundation Medicine, Inc. for patients in the United Kingdom.

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