Cancer is personal—your treatment plan should be, too

Cancer 101

Understanding how Foundation Medicine biomarker testing works starts with understanding the basics of cancer and how reading its DNA can help you and your doctor navigate available treatment options. The more you know, the more confident you may feel talking to your doctor and making decisions.

Cancer explained

Cancer may occur when cells grow out of control and potentially spread into your body’s tissues. This happens because the DNA that tells a cell what to do is not working as it should. This is known as a alteration. Usually, our natural immune system can stop abnormal cell growth before problems happen. But when it doesn’t, cells keep growing and dividing.

In some cases, the cancer stays in one place (known as a localized tumor). In other cases, it spreads (known as a metastatic tumor). When tumors are metastatic, they consume the body’s resources as they grow and can damage healthy tissue and organs.

The basics of biomarker testing

It’s important to understand key terms that play a role in biomarker testing.

Cells

Cells are basic units that make up your body. Our bodies are made up of trillions of cells.

DNA

DNA carries genetic information and passes it from one generation to the next. DNA instructs cells how to grow and divide; DNA mutations may lead to cancer growth. DNA is like an instruction manual inside every cell, with chapters called genes.

Genes

Genes are segments of DNA where alterations may be found with genomic testing. Genes tell cells what to do, including when to make new cells.

Alterations

Alterations are a subset of alterations and can cause DNA changes that can influence cancer growth. For example, mutations in BRAF, EGFR, HER2, and KRAS genes are associated with advanced solid cancers.

Biomarkers

Biomarkers are measurable characteristics within a cancer cell. The status of certain biomarkers may predict response to immunotherapy treatments. Analyzing both genomic alterations and biomarkers can provide critical information about how your cancer may respond to treatment.

Now that you know the basics, let’s bring it all together. Foundation Medicine biomarker testing reads your tumor’s DNA, searches for genomic alterations in over 300 genes, and analyzes biomarkers. This information can be used to identify how your tumor may respond to treatment.

Discover how understanding the specifics of your cancer can help you and your doctor make informed treatment decisions.

Differences between genomic tests

When doctors need a more comprehensive understanding of your cancer, they may order a genomic test. However, not all genomic tests are created equal.

Comprehensive genomic profiling (CGP) provides a broad analysis by analyzing many genes with one test.

Hotspot tests look for a relatively small number of biomarkers. They check multiple genes for a specific tumor’s “hotspot” region. However, hotspot testing can miss opportunities to identify alterations due to the test’s limited scope.

Your doctor will work with you to determine which test is right for you.

What kind of information can the test provide?

No matter your results, your report can help inform treatment decisions. Your results may include alterations and biomarkers that have been identified. This information may lead to the following:

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Targeted therapies that may stop the growth of cancer cells by targeting certain alterations

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Immunotherapies that may help your body’s own natural immune system attack cancer cells

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Clinical trials that allow eligible patients to access new potential treatments that are in development

Important Safety Information

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FoundationOne CDx and FoundationOne Liquid CDx

FoundationOne®CDx and FoundationOne®Liquid CDx are qualitative next-generation sequencing based in vitro diagnostic tests for advanced cancer patients with solid tumors and are for prescription use only. FoundationOne CDx utilizes FFPE tissue and analyzes 324 genes as well as genomic signatures. FoundationOne Liquid CDx analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes. The tests are companion diagnostics to identify patients who may benefit from treatment with specific therapies in accordance with the 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 tests does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy for testing with FoundationOne CDx when archival tissue is not available which may pose a risk. When considering eligibility for ROZLYTREK® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are tested with FoundationOne Liquid CDx and 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 important risk information, please visit www.F1CDxLabel.com and www.F1LCDxLabel.com.