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  1. Recently-Approved Devices

FoundationOne CDx (F1CDx) – P170019/S048

 

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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)
Applicant: Foundation Medicine, Inc.
Address: 150 Second Street, Cambridge, MA 02141
Approval Date: November 16, 2023
Approval Letter: Approval Order

What is it?

FoundationOne CDx is a laboratory test designed to detect genetic variations in 324 genes in addition to select gene rearrangements and other biomarkers in the genomic makeup of a tumor. FoundationOne CDx is a companion diagnostic that was previously approved for the detection of genetic mutations in people who may benefit from FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, cholangiocarcinoma, prostate cancer, ovarian cancer, and solid tumors.

This approval expands the indications for use of the FoundationOne CDx test to include testing people with breast cancer that is spreading within the breast (locally advanced) or to other areas of the body (metastatic) for changes (alterations) to the PIK3CA/ AKT1/PTEN genes. Identifying solid tumors with PIK3CA/ AKT1/PTEN alterations will help identify people who may benefit from personalized treatment with TRUQAP (capivasertib) in combination with FASLODEX (fulvestrant).

How does it work?

A doctor takes a sample of cancer tissue from a solid tumor. The sample is sent to the laboratory for testing. At the laboratory, DNA is isolated from the tumor cells and mixed with chemical substances, called reagents, that can find and test DNA sequences. The sequenced DNA is then evaluated for the presence of PIK3CA/ AKT1/PTEN alterations. A medical professional reviews the results and sends a report to the doctor. The doctor uses this information to help manage the patient’s care.

When is it used?

Doctors use FoundationOne CDx to test if a person with a solid tumor is eligible for a specific therapy or personalized treatment for their cancer.

What will it accomplish?

The FoundationOne CDx test helps identify people with breast cancer who may be eligible to receive treatment with TRUQAP (capivasertib) in combination with FASLODEX (fulvestrant) 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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