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FoundationOne®CDx – P170019/S016

Photo of FoundationOne®CDx Box

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, Cambridge, MA 02141
Approval Date: June 16, 2020
Approval Letter: Approval Order

What is it? FoundationOne®CDx (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes in addition to select gene rearrangements and other biomarkers, such as tumor mutational burden (TMB), in the genomic makeup of a tumor. F1CDx is a companion diagnostic that was originally approved for the detection of genetic mutations in patients who may benefit from 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 solid tumor patients who have high tumor mutational burden (TMB). The TMB score comes from finding the number of mutations per megabase (length of a genome segment) in the tumor DNA. Identifying tumors with high levels of TMB will help patients with solid tumors get personalized treatment with KEYTRUDA® (pembrolizumab).

How does it work? The doctor orders the test and takes a small amount of cancer tissue from the solid tumor in the patient. The doctor sends this tissue sample to Foundation Medicine, Inc. for analysis. At Foundation Medicine, Inc., DNA is isolated from a patient’s tumor cells and mixed with chemical substances, called reagents, that find and test the DNA sequences. The patient’s sequenced DNA is then given a TMB score. A trained medical professional reviews the results and sends a report to the ordering doctor. The doctor uses this information to help manage patients with a solid tumor.

When is it used? To help doctors decide if a patient with a solid tumor might be eligible for treatment with KEYTRUDA® (pembrolizumab). A TMB score greater than or equal to 10 mutations per megabase in a patient’s cancer tissue means that a patient with a solid tumor may be eligible for treatment.

What will it accomplish? The F1CDx test helps to determine if patients with a solid tumor are eligible for treatment with KEYTRUDA® (pembrolizumab) based on their test results.

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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