Actionable: A finding in the report that is tied to an FDA-approved treatment option or clinical trial.
Advanced Cancer: Stage 3 or Stage 4 cancer (also called “metastatic cancer”).
Alterations: Changes in the DNA that can influence cancer growth (also called “mutations”).
Biomarker: A measurable characteristic within a cancer cell. The status of a biomarker may provide your doctor with information about potential treatment options. For example, the status of certain biomarkers can predict response to immunotherapy.
Biomarker Findings: On your Foundation Medicine report, the “Biomarker Findings” section includes the following biomarkers: microsatellite instability (MSI) and tumor mutational burden (TMB). A high level of either of these two biomarkers may indicate that you could benefit from immunotherapy. Please note, however, that in other contexts, “biomarkers” may also include gene mutations.
Biomarker Testing: You may also hear the testing referred to as genomic testing, tumor testing, molecular testing, next-generation sequencing (NGS), and genomic profiling. Biomarker testing is a general category of testing that looks for mutations in cancer genes to identify potential treatment options. Foundation Medicine performs a type of biomarker testing called comprehensive genomic profiling (CGP).
Blood Tumor Mutational Burden (bTMB): A biomarker that can be detected from your blood sample and that may help predict response to immunotherapy. bTMB is a measure of the frequency of mutations in your circulating-tumor DNA (ctDNA) when performing FoundationOne Liquid CDx.
Cells: Basic units that make up your body.
Circulating-tumor DNA (ctDNA): small DNA fragments that have come from your tumor and can be found circulating in your blood.
Clinical Trial: Process by which new potential treatments are studied and compared to existing treatment options. This can allow you to access the latest treatments that are in development.
Companion Diagnostic (CDx): A medical device which provides information essential for the safe and effective use of a corresponding drug or therapy. The test helps doctors determine if a particular treatment’s benefits to a patient will outweigh any potential risks.
Comprehensive Genomic Profiling (CGP): A method of genomic sequencing using a single test to assess hundreds of cancer-relevant genes and detect genomic alterations known to drive cancer growth. This type of genomic testing can be performed on multiple sample types. This is the type of testing performed by Foundation Medicine.
Diagnosis: The determination of a tumor type and stage of cancer.
DNA: The molecules inside cells that carry genetic information and pass it from one generation to the next. DNA instructs cells how to grow and divide; DNA mutations may lead to cancer growth.
Food and Drug Administration (FDA): The official US government agency responsible for review and approval of drugs and diagnostic tests to determine their safety and effectiveness for the intended use in patients.
Foundation Medicine: Company that performs biomarker/genomic testing called comprehensive genomic profiling (CGP).
FoundationOne CDx: A next-generation sequencing test developed by Foundation Medicine that analyzes over 300 genes and biomarkers in your tumor tissue to identify potential treatment options for advanced cancer patients with solid tumors.
FoundationOne Liquid CDx: A next-generation sequencing test developed by Foundation Medicine that analyzes over 300 genes and biomarkers detected in your blood to identify potential treatment options for advanced cancer patients with solid tumors.
FoundationOne Heme: A next-generation sequencing test developed by Foundation Medicine that analyzes a set of genes and biomarkers to identify potential treatment options for patients with hematologic (blood) cancers and sarcomas.
Genes: Segments of DNA where mutations may be found with genomic testing.
Genomic Testing: You may also hear the testing referred to as biomarker testing, tumor testing, molecular testing, next-generation sequencing (NGS), and comprehensive genomic profiling. Genomic testing is a general category of testing that looks for mutations in the genes within your tumor to identify potential treatment options. Foundation Medicine performs a type of genomic testing called comprehensive genomic profiling (CGP).
Genetic Testing: You may also hear the testing referred to as germline testing. Genetic testing looks at inherited mutations in all cells that can be passed on from your parents. Foundation Medicine does not perform genetic testing, but may incidentally identify these mutations during the testing process.
Germline Mutations: Mutations that can be found in all cells and can be inherited (passed on from your parents).
Hematologic Cancers: Blood cancers like leukemias and lymphomas.
Immunotherapy: A type of cancer treatment that helps the body’s immune system attack cancer cells.
Inherited Mutations: Mutations that can be found in all cells and that can be passed on from your parents (also called “germline mutations”).
Liquid Biopsy: This type of testing is performed on a blood sample instead of a tissue sample. It looks at DNA from your tumor that is circulating in your blood.
Genomic Loss of Heterozygosity (gLOH): A biomarker that may help predict response to a type of targeted therapy called PARP therapy. LOH refers to a change in the functioning of a gene pair that can mean there is no normal function at that location. This means a cell can be more likely to show cancer growth. This biomarker is relevant for ovarian cancer.
Microsatellite Instability (MSI): A biomarker that may help predict benefit from immunotherapy. MSI refers to a type of instability in a tumor’s DNA.
Mobile Phlebotomy: A service where a professional can come to your home to draw a blood sample for testing.
Monitoring: A type of testing that looks for disease progression and how the body responds to treatment over time.
Mutations: Changes in the DNA that can influence cancer growth (also called “alterations”).
Progression: The spread of cancer.
Solid Tumor Cancers: Cancers that start in tissue, like lung, breast, and colorectal cancer.
Somatic Mutations: Mutations that are found in cancer cells and which can lead to cancer growth. They are acquired and not inherited from a parent.
Targeted Therapy: A type of cancer treatment that attacks cancer cells with specific gene mutations. Targeted therapies often come in the form of a pill.
Tissue: A part of the body where cancer can form.
Tumor: A mass within the body caused by abnormal growth of cells.
Tumor Fraction: An estimate of the percentage of DNA found in your blood sample that is tumor DNA.
Tumor Mutational Burden (TMB): A biomarker that may help predict response to immunotherapy. TMB is a measure of the frequency of mutations in your tumor’s DNA.
Tumor Type: The type of cancer (e.g., lung cancer, breast cancer, etc.).
Turnaround Time (TAT): Amount of time to get test results.
Important Safety Information
For prescription use only. FoundationOne CDx is a qualitative genomic sequencing test for advanced cancer patients with solid tumors and analyzes 324 genes. It is intended to help doctors identify which patients may benefit from treatment with certain therapies or through clinical trials. Use of the test does not guarantee that a patient will be matched to a treatment or that all relevant genomic alterations will be detected. Some patients may require a biopsy which poses certain risks. For the full product labeling, including indications for use and risk information, visit StartWithStepOne.com.
FoundationOne Liquid CDx
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who are negative for other companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.