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Overview
We’re Here to Help
Comprehensive genomic profiling (CGP) — also known as biomarker testing or tumor profiling — is a method of cancer sequencing using a single test to access hundreds of cancer relevant genes and detect genomic mutations known to drive cancer growth. 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
FoundationOne CDx is an FDA-approved test for all solid tumors 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
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
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.
Results
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.
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Genomic Mutations
After we test your tumor tissue, blood, or bone marrow sample for gene mutations, we will report any mutations found.
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Additional Biomarkers
We also provide information about additional biomarkers that may be associated with immunotherapy response.
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Therapies
Alongside gene mutations and additional biomarkers, we list any targeted therapies or immunotherapies that your doctor may want to consider as a next step in your treatment.
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Clinical Trials
We also list clinical trial options that your doctor may want to consider.
Financial Support
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 All Foundation Medicine tests are covered by Original Medicare and Medicare Advantage for qualifying beneficiaries.2 FoundationOne CDx is also covered by TRICARE for qualifying patients. FoundationOne Heme has limited commercial health plan coverage at this time.
How does Foundation Medicine support me through the billing process?
Giving you access to insurance, billing, and financial assistance is a top priority at Foundation Medicine—and FoundationAccess™ is here to help. After we receive your test order, we start reviewing what your plan covers. If we believe you will have out-of-pocket costs, we’ll contact you by phone or mail to share important information.
Thanks to broad insurance coverage, nearly 9 out of 10 patients pay $0 for Foundation Medicine CGP tests.** If there is patient responsibility for test cost, you may qualify for a $100 out-of-pocket maximum through our financial assistance program.* You can apply at any time to see if you qualify. If you don’t qualify, payment plans may be available.
State Medicaid recipients pay $0 out-of-pocket and don’t need to apply. If you have Managed Medicaid, you should apply for financial assistance.
Applying is easy. Complete an online form or this PDF application. Or talk to a Client Services team member at:
Phone: 888.988.3639
Email: client.services@foundationmedicine.com
*Financial assistance is only available for tests ordered within the U.S. and its territories.
**Data on File, Foundation Medicine, Inc., 2022. Based on U.S. settled claims from 1/1/21 to 3/31/22 for all CGP and IHC tests offered by Foundation Medicine and reported during that time before considering any financial assistance. 64% of commercially insured and 97% of Medicare and Medicare Advantage patients had a $0 financial responsibility for Foundation Medicine testing. Some patients may have higher financial responsibility.
All Foundation Medicine tests are covered by Original Medicare and Medicare Advantage for qualifying beneficiaries
FoundationOne CDx and FoundationOne Liquid CDx
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 this is not your first FoundationOne CDx or FoundationOne Liquid CDx test, but this is a different type of cancer, either a “new primary” cancer diagnosis or your cancer has progressed* since your prior test
You have decided to seek further cancer treatment such as therapeutic chemotherapy; and
Your testing is ordered by a treating physician.
*Repeat testing (FoundationOne®CDx, FoundationOne®Liquid CDx, or FoundationOne®Heme) after disease progression (i.e., there is evidence of a new malignant growth despite response to a prior targeted therapy) may be covered under the Centers for Medicare and Medicaid Services (CMS) National Coverage Decision (NCD) for qualifying Medicare beneficiaries.)
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.
FoundationOne Heme
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. Learn more about patient protections against surprise billing.
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.
Note: If you have private/commercial insurance, a prior authorization form may be required in some cases.
FAQs
Answers to Common Questions
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Your health information may be used and disclosed for treatment, payment, healthcare operations, and other purposes permitted or required by law. Foundation Medicine may also use your health information to create and use “de-identified” datasets and provide these datasets to biopharma partners, academic researchers and other third parties to help identify new and better treatments and to advance our understanding of how cancer treatments work. De-identified datasets means that information that could be used to identify a specific individual was removed.
Your de-identified information may be aggregated with thousands of other patients’ de-identified information to generate insights essential to accelerating new discoveries in cancer treatment and ultimately enabling better patient care. However, Foundation Medicine respects the individual rights of its patients, including a right to opt-out of disclosure of their de-identified information to third parties for future research purposes. Any de-identified information already included in a dataset created prior to your opt-out will not be impacted. If you would like to opt out, please contact Foundation Medicine at privacy@foundationmedicine.com or 1 (888) 988-3639.
Please visit Foundation Medicine’s Notice of Privacy Practices for more information on how Foundation Medicine uses your health information.
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Foundation Medicine has test options available across different cancer types and sample types:
FoundationOne CDx: All solid tumor cancers (e.g. lung, ovarian, breast, colorectal). It is performed from a tissue biopsy.
FoundationOne Liquid CDx: Also all solid tumor cancers. FoundationOne Liquid CDx is a blood-based test or “liquid biopsy” that tests circulating tumor DNA (ctDNA) that can be released from cancer cells into the bloodstream. It is performed from a simple blood draw.
FoundationOne Heme: Blood cancers (e.g. leukemias) and sarcomas (soft tissue cancers). It can be performed from a tissue biopsy or from a liquid sample, like blood or bone marrow, depending on your cancer type. You can discuss the preferred sample type with your doctor.
Foundation Medicine tests must be ordered by a doctor or healthcare provider. -
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.
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Testing identifies the DNA alterations that may be driving the growth of a specific tumor. 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. Genetic testing looks at inherited mutations that are in all cells, including the tumor, and are passed on from your parents.
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Foundation Medicine tests each look at over 300 cancer-related genes to see if there are mutations, or changes, that may be relevant to your cancer. Gene lists are available on our website, on the page for each Foundation Medicine test. Knowing these mutations can help your doctor understand what types of treatment might work best for your cancer.
The Foundation Medicine tests also look at biomarkers – like TMB (tumor mutational burden), MSI (microsatellite instability), and gLOH (genomic loss of heterozygosity) – which can provide more information that might be helpful for determining your treatment options. See the glossary below for a description of these biomarkers.
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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.
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Foundation Medicine accepts all insurance plans; however, we are currently not in-network providers with all insurance plans and not all plans may provide coverage for CGP tests. Through our FoundationAccess program, we complete a benefits investigation and reach out to patients whom we expect may have out-of-pocket costs. Foundation Medicine accepts all insurance plans. More than 80 health plans cover one or more Foundation Medicine CGP tests including Original Medicare and Medicare Advantage. Qualifying Original Medicare beneficiaries have no out-of-pocket costs for Foundation Medicine NGS testing.
Our FoundationAccess™ program reviews your benefit information and contacts you if we expect you’ll incur out-of-pocket costs. If there is a cost and you can’t afford it, financial assistance is available for those who qualify.* You can apply anytime to see if you qualify. If you do qualify, you’ll pay no more than $100 in out-of-pocket costs. Financial assistance isn’t available for patients who have insurance and choose to be self pay.
Applying is easy. Complete an online form or this PDF application.
Or talk to a Client Services team member at:
Phone: 888.988.3639
Email: client.services@foundationmedicine.com*Financial assistance is only available for tests ordered within the U.S. and its territories.
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For patients in the United States who are paying directly (self-pay), the rates for testing are:
FoundationOne®CDx, FoundationOne®Liquid CDx, and FoundationOne®Heme: $3,500.00
PD-L1 (Immunohistochemistry): $125.00
If you have an out-of-pocket cost for our testing and can’t afford it, Foundation Medicine offers financial assistance for those who qualify.* You can apply at any time to see if you qualify. If you qualify, you'll pay no more than $100 in out-of-pocket costs. Financial assistance isn’t available for patients who have insurance and choose to be self pay.
Applying is easy. Complete an online form or this PDF application.
Or talk to a Client Services team member at:
Phone: 888.988.3639
Email: client.services@foundationmedicine.com*Financial assistance is only available for tests ordered within the U.S. and its territories.
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When your doctor orders a Foundation Medicine test, they can send your tissue, blood, or bone marrow sample directly to Foundation Medicine. Here are some additional options:
Tissue samples: Foundation Medicine can reach out to your lab to request the tissue sample after getting the order from your doctor.
Blood samples: Foundation Medicine can arrange for an at-home blood draw called “mobile phlebotomy,” where a professional can come to your home to draw your blood sample. Please contact our Client Services Team for more detailed information.
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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.
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After we receive your sample in our lab, we go through a series of detailed checks to make sure we can return results to your doctor. For a tissue sample, we check that there is enough tumor material and tumor DNA in the sample. For all tests, we have additional quality checks before we can issue results.
If we are not able to get results, we will let your doctor know so that a different sample could be sent in. For a tissue test, this could be a different tissue sample or a blood sample. For a test on blood, this could be a redraw. We are committed to working with you and your doctor to find the best chance for getting results to help guide your care.
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There is no charge for any test where we cannot get results, only if it produces a final report. If we cannot get results, a failed report will be issued.
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A copy of the report can be shared with a patient if you request it by contacting our Client Services Team at client.services@foundationmedicine.com or by calling +1 (888) 988-3639.
We’re Here to Help
If you didn’t find what you need or want to talk to someone further, our Client Services team is on hand to help. Call +1 (888) 988-3639 or email client.services@foundationmedicine.com.
Additional Notes
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
*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 our laboratory developed test (LDT) please see the Technical Specifications.
Important Safety Information
Select
FoundationOne CDx
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.