How is my information used?
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 email@example.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.
Can you describe your available tests?
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.
What can I learn from a Foundation Medicine test?
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.
How does genomic testing differ from genetic testing, and what does Foundation Medicine perform?
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.
What mutations and biomarkers are included in Foundation Medicine tests?
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 for a description of these biomarkers.
When should I get a Foundation Medicine test if I have solid tumor cancer?
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.
Does insurance cover my Foundation Medicine comprehensive genomic profiling test?
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.
*Financial assistance is only available for tests ordered within the U.S. and its territories.
What is the process for sending a sample to Foundation Medicine?
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.
What types of samples can be sent in for a solid tumor cancer diagnosis?
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.
What are some reasons I may not be able to get results after my sample is sent in?
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.
Is there a charge if results cannot be obtained?
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.