• When should I get tested?

    Foundation Medicine® tests for solid tumor cancers are generally used for more advanced disease whereas Foundation Medicine tests for hematologic malignancies and soft tissue sarcomas can also be used at diagnosis, for prognostication, and to guide overall clinical management. Talk with your doctor to see if our tests are right for you.

  • Do the tests apply to all types of cancer?

    Our suite of comprehensive genomic profiling (CGP) assays can help deliver meaningful molecular insights across the broad spectrum of tumor types including but not limited to:

    FoundationOne®: Non-Small Cell Lung (NSCLC), Breast, Colon, Melanoma, and Brain

    FoundationOne® Heme: Leukemias, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, and Sarcomas

    FoundationACT®: Lung, Breast, Prostate, Gastro-Intestinal, Melanoma, and Brain

    FoundationFocusTM CDxBRCA: Ovarian


  • Does insurance cover my test?

    Foundation Medicine accepts all insurance plans; however, we are currently not in-network providers with all insurance plans. If you are uninsured, or if you have insurance and cannot afford the applicable out-of-pocket cost, you have options. You can fill out a financial assistance application to determine upfront what your maximum out-of-pocket expense might be. Payment plans may also be available. Please contact our Client Services Team for more detailed information.

  • How does genomic testing differ from genetic testing?

    Genetic testing detects hereditary (inherited from parents) alterations in DNA while genomic testing detects acquired (over the course of a lifetime) alterations in DNA. Acquired alterations are responsible for the majority of cancers and may impact tumor growth, spread, and response to therapy.

  • Do all test results lead to actionable treatment options?

    Each individual cancer is unique and test results vary depending on the tumor type. When applicable, test results may help identify:

    1. A therapy approved to treat your specific tumor type and shown to be effective in targeting one or more of the alterations found by the test
    2. A therapy approved in another tumor type but possibly effective in targeting one or more of the genomic alterations found by the test
    3. A clinical trial evaluating therapies under development which may work by targeting an alteration found by the test

  • Who is eligible for the tests?

    Any patient with a solid tumor, hematologic malignancy, or sarcoma is eligible for our tests.

  • What is the clinical utility of these tests?

    FoundationOne may provide clinical utility for patients across many different indications, including but not limited to:

    Lung Cancer

    • Identification of targetable alterations such as ALK or ROS1 missed by standard hotspot testing
    • TMB-high status associated with response to immunotherapy

    Colorectal Cancer

    • MSI- and TMB-high status in a single assay
    • Identification of HER2 alterations or those associated with lack of benefit to anti-EGFR therapy

    Breast Cancer

    • Detection of BRCA1/2 or ERBB2 mutations undetectable by standard IHC or FISH testing

    Melanoma

    • Identification of novel BRAF mutations
    • TMB-high status associated with response to immunotherapy

    Ovarian Cancer


    FoundationOneHeme may provide clinical utility for patients across several different indications, including but not limited to:

    Acute Lymphoblastic Leukemia (ALL)

    • To identify BCR-ABL-like fusions that confer sensitivity to targeted therapies
    • To assess for mutations that predict adverse outcomes indicating the role of allogeneic transplantation
    • Identification of rare actionable BCR-ABL1 mutation missed by standard testing
    • View case report

    Acute Myeloid Leukemia (AML)

    • In newly diagnosed patients: for the development of an integrated risk profile for targeted treatment and maintenance plans
    • In relapsed/ refractory patients: to provide deeper insight which may lead to more targeted treatment options for patients
    • Identification of targeted therapies that may serve as a bridge to transplantation
    • View case report

    Myelodysplastic Syndrome (MDS)

    • For the evaluation of patients with suspected MDS to help determine prognosis and risk of leukemic transformation
    • For patients with confirmed MDS to establish presence of clonal hematopoiesis and refine disease prognosis

    Myeloproliferative Neoplasm (MPN)

    • To confirm diagnosis and provided deeper insights into prognosis and risk stratification
    • To guide the use of transplantation or novel therapies
    • Identification of novel fusion which can lead to diagnostic reclassification
    • View case report

    Sarcomas

    • To confirm molecular subtype and inform treatment pathway
    • To guide the use of novel therapies and immune-oncology agents
    • Identification of VEGFR amplifications which helped guide treatment using VEGFR inhibitors
    • View case report


    In all patients with relapsed/ refractory disease to provide deeper insight which may lead to more targeted treatment options for patients

    Multiple Myeloma

    • Detection of actionable alterations impacting the RAS/MAPK pathway
    • View case report

    Non Hodgkins Lymphoma (NHL)


    FoundationACT may provide clinical utility for patients across several different disease indications including, but not limited to:

    Lung Cancer

    • Identification of resistance mutations or fusions such a ROS1, often missed by other ctDNA assays

    Gastrointestinal (GI) Carcinomas

    • Identification of reportable alterations in cancers of the GI tract and anus

    Breast Cancer

    • Detection of ESR1 mutations in hormone-resistant metastatic breast cancer,

    Prostate Cancer

    • Ability to detect a number of alterations such as BRCA1/2 reversion mutations, when obtaining tissue is not feasible

  • How is comprehensive genomic profiling different from single-gene ("hot spot") testing for solid tumors?

    Single-gene testing identifies only one or two classes of genomic alterations. Comprehensive genomic profiling (CGP) approach identifies four classes of genomic alterations: base substitutions, insertions and deletions/indels, copy number alterations, and rearrangements.

  • Whom can I contact with additional questions?

    Client Services

    Phone: 888.988.3639

    Fax: 617.418.2290

    Email: Client.Services@foundationmedicine.com

  • What services does Foundation Medicine offer for biopharmaceutical companies?

    Foundation Medicine is your partner to help accelerate biomarker-driven drug development - from target discovery to commercial launch, we can assist Biopharma partners with the following offerings:

    Research

    Our partners can leverage our genomic knowledgebase in their clinical scientific investigations or use our assays to perform biomarker discovery in prospective and retrospective clinical specimens.

    Development

    We facilitate molecularly-guided clinical trial design by connecting patients with trials, targeting their unique genomic profiles. We utilize our comprehensive genomic platform as a Clinical Trial Assay (CTA) for prospective patient selection.

    Commercialization

    We offer comprehensive Companion Diagnostic development, full regulatory support services (including submissions), as well as integrated post-approval services.

  • When does Foundation Medicine expect approval of its universal companion diagnostic?

    For all available information, please refer to our press release “FoundationOne® Accepted by FDA and CMS for Parallel Review and FDA Expedited Access Pathway.

  • How can genomic data generated by Foundation Medicine assays be used for biomarker discovery?

    FoundationCORE™ is a molecular information knowledgebase that contains genomic information from more than 120,000 patients whose tumors have been profiled by Foundation Medicine. Our partners can access and query this knowledgebase through our web-based platform, FoundationINSIGHTSTM. This dataset is notably enriched for rare cancers relative to population prevalence, making it an invaluable source for genomic targeting of populations with high unmet medical need.

    Learn more about how you can partner with us for biomarker discover.

  • How can working with Foundation Medicine help facilitate drug development?

    Foundation Medicine offers a next-generation sequencing (NGS) cancer assay with the potential to incorporate multiple companion diagnostic (CDx) markers into one test. This novel CDx development model can help our partners meet accelerated clinical development timelines, facilitate CDx and drug approval, and supports rapid commercial launch.

    Learn more about our companion diagnostic development offering.

  • How does Foundation Medicine help with clinical trial design and enrollment?

    Foundation Medicine sits at the nexus of medicine and pharmaceutical research, combining our multi-faceted expertise with more than 120,000 sequenced patient samples and over 30 pharmaceutical partners. We help our partners optimize their clinical trials in a number of ways:

    Trial Design

    Utilize more than 120,000 profiles in the FoundationCORETM knowledgebase to define biomarker criteria, map geographic ordering patterns and select sites with the highest testing volumes.

    Trial Screening for Enrollment

    Find and enroll patients efficiently, including those with rare genomic findings. We profile hundreds of new patients per week.

    Trial Access

    Access a just-in-time network of more than 300 sites to enroll matched patients in remote geographies.

    Learn more about our clinical trial offerings.

  • What are the specifications of Foundation Medicine’s FoundationCORE™ database?

    FoundationINSIGHTSTM is a secure web application, which pulls data from our FoundationCORE knowledgebase of more than 120,000 de-identified patient genomic profiles, spanning more than 150 cancer subtypes. Learn more about our FoundationINSIGHTS platform.

  • How do I contact someone in the biopharma group to discuss a project?

    To contact our Biopharma Solutions team please email: pharmasolutions@foundationmedicine.com or call 617-418-2200.