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FoundationOne® CDx - P170019/S017


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: October 23, 2020
Approval Letter: Link to Approval Order

What is it? 

FoundationOne CDx (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes. F1CDx is a companion diagnostic that has been approved for the detection of genetic mutations in patients who may benefit from one of twenty-three FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, ovarian cancer, cholangiocarcinoma, prostate cancer, and TMB for solid tumors.

This approval expands the indications for use of the F1CDx test to include an additional companion diagnostic indication for solid tumor patients who have  gene rearrangements that can lead to fusions of the genes NTRK1, NTKR2, and NTRK3. Gene fusions in NTRK1, NTRK2, NTRK3, collectively referred to as NTRK gene fusions lead to fusion proteins that are both abnormally expressed and activated, resulting in activation of downstream pathways that can cause cancer. Identifying NTRK1, NTRK2, and NTRK3 gene fusions will help determine if patients with solid tumors are eligible for personalized treatment with VITRAKVI® (larotrectinib).

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 searched for the presence or absence of NTRK1, NTRK2 or NTRK3 fusions. A trained medical professional reviews the results and sends a report to the ordering doctor. The doctor uses this information to help manage the patient’s solid tumor, cancerous mass, or cancerous lumps of tissue.

When is it used?

F1CDx is used to help doctors decide if a patient with metastatic, solid tumors might be a candidate for treatment with VITRAKVI® (larotrectinib). This may be an option when the cancer has spread and the tumor removal is too risky, the tumors continue to grow after other treatments have been tried, or if there are no other treatments available.

What will it accomplish?

The F1CDx test helps to determine if  patients with a solid tumor are eligible for treatment with VITRAKVI® (larotrectinib) 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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