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FoundationOne CDx - P170019/S011

FoundationOne CDx

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: FoundationOne®CDx (F1CDx)
PMA Applicant: Foundation Medicine, Inc.
Address: 150 Second Street, 1st Floor, Cambridge, MA 02141
Approval Date: May 6, 2020
Approval Letter: Approval Order

What is it? 

FoundationOne® CDx (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes, including the MET gene, in tumor tissue. F1CDx is a companion diagnostic that was originally approved for the detection of genetic variations in patients who may be eligible for treatment with one of fifteen FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer.

This approval expands the indications for use of the F1CDx test to include lung cancer patients with certain genetic mutations in the MET gene in tumor tissue who may benefit from treatment with TABRECTA® (capmatinib). Identifying these changes will help patients with lung cancer get personalized treatment with TABRECTA® (capmatinib). 

When is it used? 

Doctors use F1CDx to determine if a patient with lung cancer that is advanced (metastatic) or cannot be removed with surgery might be eligible for treatment with TABRECTA® (capmatinib).

How does it work? 

The doctor orders the test. A tissue sample from the lung tumor tissue of a patient is taken by the doctor, and the prepared sample is sent to Foundation Medicine, Inc. At Foundation Medicine, Inc., DNA is isolated from a tumor tissue section, and then mixed with chemical substances (reagents) that detect and analyze the DNA sequences. The patient’s sequenced DNA is then evaluated for the presence or absence of certain mutations in the MET gene. A trained medical professional reviews the results, and then a report is sent to the ordering doctor. The doctor uses this information to help treat patients with lung cancer. Lung cancer patients whose cancer has spread to other areas and are found to have mutations in the MET gene are eligible for treatment with TABRECTA® (capmatinib).

What will it accomplish?

The F1CDx test helps to determine whether patients with lung cancer that has spread to other areas should be considered for treatment with TABRECTA® (capmatinib).

When should it not be used? 

There are no known reasons not to use this test.

Additional information (including warnings, precautions, and adverse events): 

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