• 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.

  • 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
    • To determine microsatellite instability status, which has been established in the clinical setting to confer sensitivity to immunotherapy agents including nivolumab and pembrolizumab
    • 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

    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

  • Who is eligible for the tests?

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

  • Whom can I contact with additional questions?

    Client Services

    Phone: 888.988.3639

    Fax: 617.418.2290

    Email: client.services@foundationmedicine.com

If you have a question that isn't answered above, you can also contact us using the form below and we'll follow up by email in 1-2 days