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Comprehensive genomic profiling (CGP) — also known as biomarker testing or tumor profiling — is a method of cancer testing that can find the mutations in your cancer’s DNA that may be causing your cancer to grow. The mutations in your cancer’s DNA may help your doctor identify a targeted therapy, immunotherapy, or clinical trial that is right for you. The resources below can help you navigate through the Foundation Medicine testing process.
For general information about CGP testing, available treatment options, and patient videos please visit StartWithStepOne.com.
FoundationOne CDx is an FDA-approved test for all solid tumor cancers performed on a tissue biopsy. It uses CGP to search 324 genes for cancer-relevant mutations in the DNA of your tumor to help identify targeted therapy, immunotherapy, and clinical trial options that may be right for you.
FoundationOne Liquid CDx is also an FDA-approved test for all solid tumors that analyzes over 300 genes from just a simple blood draw, called a liquid biopsy. FoundationOne Liquid CDx can help identify targeted therapy, immunotherapy, or clinical trial options that may be right for you.
FoundationOne Heme is a laboratory developed test for blood cancers like leukemia and lymphoma, and for sarcomas, that tests over 400 genes and biomarkers to identify targeted therapy, immunotherapy, or clinical trial options that may be right for you. The test can be performed on blood, bone marrow, or a tissue biopsy.
What Do the Results Mean?
When testing is complete, a report will be sent to your doctor. You can also request a copy of your report by contacting us. Ask your doctor about your Foundation Medicine testing options so they can help guide treatment decisions for you.
After we test your tumor tissue, blood, or bone marrow sample for gene mutations, we will list any mutations found in the report.
We also provide information about additional biomarkers that may be associated with immunotherapy response.
Making Testing Accessible
Foundation Medicine is committed to providing patients with resources and support throughout the testing process with the help of the FoundationAccess™ program. After your doctor orders a Foundation Medicine test and we receive your sample, we will contact you by phone, or mail you materials, to share important information about what you can expect as your test moves forward.
Some commercial health plans such as Cigna and many BlueCross BlueShield plans offer coverage for Foundation Medicine testing services.1 Medicare covers FoundationOne CDx, FoundationOne Liquid CDx, and FoundationOne Heme for qualifying patients.2 FoundationOne CDx is also covered by TRICARE for qualifying patients. FoundationOne Heme has limited commercial health plan coverage at this time.
Financial assistance is available for qualifying patients who have out-of-pocket costs associated with Foundation Medicine testing.* Financial assistance is based on need and can be applied for at any time before during or after testing. Payment plans may also be available based on your financial situation.
*Foundation Medicine's Financial Assistance Program is only available to patients whose tests were ordered within the United States and U.S. territories.
For many patients with advanced solid tumors, FoundationOne CDx and FoundationOne Liquid CDx are covered by Medicare.
If you are an Original Medicare beneficiary and you meet the following criteria, Foundation Medicine expects that you will have no out-of-pocket costs for FoundationOne CDx or FoundationOne Liquid CDx solid tumor testing:
You have either recurrent, relapsed, refractory, metastatic, or advanced (stages III or IV) cancer;
This is your first time having a FoundationOne CDx or FoundationOne Liquid CDx test for this cancer diagnosis OR you had a FoundationOne CDx or FoundationOne Liquid CDx test before, but this is a different type of cancer—a “new primary” cancer diagnosis;
You have decided to seek further cancer treatment such as therapeutic chemotherapy; and
Your testing is ordered by a treating physician.
Note: If you are an Original Medicare beneficiary, you may need to sign an Advance Beneficiary Notice (ABN) prior to the test order. Your physician will determine if an ABN is required.
If you are an Original Medicare beneficiary and you meet the following criteria, Foundation Medicine expects that you will have no out-of-pocket expenses for your FoundationOne Heme testing:
You have been diagnosed with refractory/metastatic acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPN) or you have a suspected myeloid malignancy with an undefined cytopenia for greater than 4 months, and other possible causes have been reasonably excluded, AND
You have not previously received or are not currently receiving NGS testing on the specimen for which the test is currently being ordered, AND
You have not been tested with the same test for the same genetic content
Note: If you are an Original Medicare customer, you may need to sign an Advance Beneficiary Notice (ABN) prior to the test order. Your physician will determine if an ABN is required.
Foundation Medicine will work directly with your insurance company to try to obtain coverage.
Depending on the terms of your insurance plan, you may have financial responsibility for co-pay, co-insurance, or deductible as directed by your plan.
If your insurance company denies coverage, with your consent, we will work on your behalf to attempt to obtain coverage and will work with you and your doctor in pursuing appeals to minimize the financial burden. If you are eligible for financial assistance, this is applied to your out-of-pocket cost.
Note: If you have private/commercial insurance, a prior authorization form may be required in some cases.
Answers to Common Questions
Foundation Medicine testing looks at the genes inside your cancer cells to find mutations (also called alterations) and other biomarkers. The test results may provide potential options for you and your doctor to consider in your treatment:
Therapies you may be eligible for: We identify FDA-approved targeted therapies or immunotherapies that may help you based on the mutations and biomarkers found in your cancer. These therapies may have been approved for your cancer type or they may have been approved in other cancer types.
Rule out therapies: We look at over 300 important genes to help your doctor know which treatments may not work for you.
Clinical trials: We match your results with treatments that are currently in development through clinical trials. Talk to your doctor about which clinical trial options may be available and if you might qualify.
Even if you have a report with no actionable mutations, that is helpful for your doctor to know for your treatment plan, and new treatment options may become available in the future.
If you can get tested soon after your diagnosis of advanced cancer (Stage 3 or Stage 4), that can give you and your doctor a chance to follow a personalized treatment strategy right away. The testing can also be performed when your cancer has progressed or at a point when you and your doctor are looking to decide on your next treatment step. Your doctor will work with you to decide when testing may be appropriate for your specific cancer.
Genomic testing looks at mutations found in the tumor itself (somatic mutations). Genetic testing looks at inherited mutations that are in all cells, including the tumor, and are passed on from your parents (germline mutations). The testing offered by Foundation Medicine is a type of genomic testing called comprehensive genomic profiling (CGP). It looks for mutations in over 300 genes in the tumor with one sample. The mutations in the tumor are what may impact tumor growth, spread, and response to therapy.
Foundation Medicine testing may identify both kinds of mutations (somatic and germline), but does not distinguish between the two. If you have a Foundation Medicine test which incidentally identifies a gene mutation that is potentially germline, then genetic counseling and follow-up genetic (germline) testing can be considered by you and your doctor.
You should talk to your doctor about whether testing your tumor tissue or a blood sample might be the best option for you at this time:
FoundationOne CDx requires a tissue sample from a biopsy. You may already have a tissue sample available, or a new biopsy could be required. The most recent sample will most closely reflect the current state of the cancer.
FoundationOne Liquid CDx testing requires a blood sample (sometimes called a “liquid biopsy”) and can be a good option to consider if you do not have a tissue sample available, or if a tissue biopsy cannot be performed.
If a bone sample is your only tissue sample available, talk to your doctor about whether it makes sense to send the bone sample, a blood sample, or consider a new tissue biopsy. If you or your doctor have additional questions, we are here to help.
Foundation Medicine accepts all insurance plans; however, we are currently not in-network providers with all insurance plans. Through our FoundationAccess program, we complete a benefits investigation and reach out to patients whom we expect may have out-of-pocket costs. If you are uninsured, or if you have insurance and cannot afford the out-of-pocket cost, you can apply for financial assistance, and payment plans may also be available. Medicare coverage is available for FoundationOne CDx and FoundationOne Liquid CDx for eligible Medicare beneficiaries. Please contact our Client Services Team for more detailed information.
A copy of the report can be shared with a patient if you request it by contacting our Client Services Team at email@example.com or by calling +1 (888) 988-3639.
FoundationOne Heme was developed and its performance characteristics determined by Foundation Medicine. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information on this laboratory developed test please see the Technical Specifications at foundationmedicine.com/f1h.
1A select number of commercial payers have developed medical policy coverage for Foundation Medicine's FoundationOne CDx and FoundationOne Liquid CDx tests for commercially-insured patients. Foundation Medicine's other CGP test (FoundationOne Heme) has limited third party payer commercial coverage. In each case, coverage is pursuant to applicable payer medical policy and patient benefit plans.
2Medicare and Medicare Advantage members have coverage of FoundationOne CDx, FoundationOne Liquid CDx and FoundationOne Heme in accordance with the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) criteria
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. Patients who are negative for 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.