Our new liquid biopsy test is FDA-approved.
Learn more below


Every cancer is unique.
Your treatment plan
should be too.

If you ever face advanced cancer,
ask your doctor about the
FoundationOne®CDx test.

Cancer is personal.

Thankfully, doctors know more than ever before about how to treat it. But cancer isn’t just one disease. Each person’s cancer is unique. Understanding what makes your cancer unique can help you and your doctor create a treatment plan that’s more personalized for you. FoundationOne CDx could help. This website will help you understand how.

See Important Use and Risk Information.

What is FoundationOne®CDx?

FoundationOne CDx is a test for people with any type of solid . It uses comprehensive genomic profiling (CGP) to search 324 genes for cancer-relevant mutations in the of your tumor. The results of the test may help you and your doctor explore cancer treatment options beyond, or in addition to, chemotherapy and radiation therapy.

FDA-approved

FDA–APPROVED

All solid tumors

ALL SOLID
TUMORS

Covered by Medicare*

COVERED BY
MEDICARE*

*FoundationOne CDx is the first FDA-approved test of its kind and is covered by Medicare for qualifying patients.

NOW FDA-APPROVED

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FoundationOne®Liquid CDx

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FoundationOne®
Liquid CDx

FoundationOne Liquid CDx analyzes over 300 genes from a simple blood draw—making it the most comprehensive FDA-approved liquid biopsy test on the market, using just two tubes of blood. Similar to FoundationOne CDx, our liquid biopsy is approved for all solid tumors and is covered by Medicare for qualifying patients. Your doctor will determine which test is right for you.

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Available by prescription only. Use of these tests does not guarantee a patient will be matched to a treatment. Please see the Important Use and Risk Information at the bottom of this page.

"If I don’t have cancer, why do I need to know about FoundationOne CDx?"


1 in 3 people in the United States will be diagnosed with cancer in their lifetime.1 And while not all of them experience advanced cancer, knowing what to do if you or a loved one ever face such a situation can help you be better prepared.

By starting with step one—FoundationOne CDx—patients with advanced cancer and their doctors will have a clearer picture of what they’re facing.

1National Cancer Institute. Cancer Stat Facts: Cancer of Any Site (based on 2014-2016 data). Accessed May 23, 2019.

What is comprehensive genomic profiling (CGP)?

CGP reads the DNA from tumor cells to identify . CGP is also called biomarker testing, genomic profiling, or tumor profiling. The video below will help break down what causes cancer to grow and spread, and how identifying your unique biomarkers can help inform treatment plans that are as personalized as possible.

How is CGP with FoundationOne CDx different from more limited testing?

When doctors need to understand what makes a patient’s cancer unique, they have several testing options to consider. Many of these tests were designed to look for a relatively small number of biomarkers. These “hotspot” tests check between 1 and about 50 unique biomarkers. As a result, the insight hotspot tests can provide is limited.

In contrast, comprehensive genomic profiling with the FoundationOne CDx test provides a much broader analysis by looking at over 300 genomic mutations and biomarkers at once. With this level of insight, your doctor can make more informed decisions about treatment options that are personalized to your cancer.

For certain mutations and biomarkers that may be uncovered by the FoundationOne CDx test, there are already FDA-approved therapies associated with certain cancer types, including non-small cell lung cancer (NSCLC), melanoma (skin cancer), breast cancer, ovarian cancer, prostate cancer, and others. The presence of a mutation does not guarantee that you will be matched with an FDA-approved therapy. FoundationOne CDx is a test for all solid-tumor cancer types which may identify therapies your doctor may find appropriate for you.

How is genomic profiling different from genetic testing?

FoundationOne CDx testing uses genomic profiling that looks for mutations and other cancer-relevant changes in the tumor itself. The test does not distinguish between germline (inherited) and somatic (not inherited) mutations. It does not provide information about susceptibility.

Genomic profiling

Genomic profiling

Genomic profiling detects mutations that may impact a tumor's growth, spread, and/or response to therapy. Mutations may be inherited or acquired over a lifetime.

Genetic testing

Genetic testing

Genetic testing looks at inherited traits in a person’s genes and certain cancer-relevant mutations a person could get from their parents.

FoundationOne CDx is not a home-based ancestry test.


Home-based ancestry tests may look at inherited cancer-relevant mutations, typically from saliva cells. FoundationOne CDx is not an ancestry test and does not provide information about genetic risks for developing disease. Our CGP approach looks within a solid tumor’s cells for cancer-relevant mutations in hundreds of genes. They may be inherited or acquired over a lifetime. This test is by prescription only.

How is the test performed?

Foundation Medicine offers the FoundationOne CDx test and conducts the tumor testing in its laboratory.

1

It starts in your doctor’s office

Your doctor will need to determine if this test is right for you and if you are a candidate for a biopsy. A biopsy may pose a risk to a patient. Past biopsied tissue may also be used.

2

Your doctor orders the test for you

After your doctor orders the test, Foundation Medicine contacts the lab that has your tumor sample and coordinates to have it sent to our lab.

3

Your tumor sample is analyzed in our lab

We study the DNA in your tumor sample using CGP to detect mutations and other biomarkers that may indicate if a , , or a could be an option for you.

See Important Use and Risk Information.

4

Your report arrives in about 2 weeks*

We send the report containing your results to your doctor in about 2 weeks. You can also request a copy of your report by contacting our Care Team.
*Typical turnaround time from the time Foundation Medicine receives your specimen from your doctor is <2 weeks.

FoundationOne(R)CDx packaging

Does Foundation Medicine offer other types of genomic tests?


Foundation Medicine also offers a CGP test that is a laboratory developed test for and .

Your doctor will determine which test is best for you.

Learn more about Foundation Medicine’s testing options on our corporate website.

learn more

Your report may help you and your doctor
answer three important questions.

See Important Use and Risk Information.

sample report

Sample report

Are there any FDA-approved therapies for my cancer?

We report FDA-approved targeted therapies that your doctor may consider if there are certain present in your solid tumor. Here’s a list of the FDA-approved targeted therapies for which FoundationOne CDx is an FDA-approved .

We also report FDA-approved immunotherapies if there are present in your solid tumor. Your doctor will determine if any of these therapies may be right for you.

Are there any clinical trials we could consider?

When applicable, your results are matched with potential treatments that are currently being tested in clinical trials. Talk to your doctor about which clinical trials may be available and if you qualify for them.

Are there any FDA-approved therapies for my cancer?

We report FDA-approved targeted therapies that your doctor may consider if there are certain present in your solid tumor. Here’s a list of the FDA-approved targeted therapies for which FoundationOne CDx is an FDA-approved .

We also report FDA-approved immunotherapies if there are present in your solid tumor. Your doctor will determine if any of these therapies may be right for you.

Are there any therapies that we can rule out?

FoundationOne CDx looks at hundreds of important genes and biomarkers to help your doctor know which treatments may not work for you, which could potentially help you avoid unnecessary treatments.

Financial questions?


FoundationOne CDx is covered by Medicare for qualifying patients.

Foundation Medicine accepts all insurance plans; however, we are out of network with most. 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 point during the testing process by filling out a financial assistance application.

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If you don’t have cancer, your next step could help someone who does.

If you or a loved one ever faces advanced cancer, make sure you, and they, know what to say. Now, you can ask your doctor to start with step one, FoundationOne CDx. Help spread awareness about CGP and how FoundationOne CDx could help doctors connect patients with personalized treatment options. Use the buttons below to post to Facebook or Twitter and use our hashtag #StartWithStepOne. Or, copy a link and share via email or text message.

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Metastatic colorectal cancer (mCRC) is a complex disease, and mCRC patients have a 14% survival rate five years after their diagnosis. 43% of mCRC patients are matched to an on-label therapy, but a match does not guarantee that the treatment is right for a patient or that a patient will achieve a similar outcome. Speak with your doctor for more information.

If you or someone you love is facing advanced cancer, you can start with step one.

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