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FoundationOne®CDx - P170019/S006

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
PMA Applicant: Foundation Medicine, Inc.
Address: 150 Second Street, 1st Floor, Cambridge, MA 02141
Approval Date: December 3, 2019
Approval Letter: Approval Order

What is it? FoundationOne®CDx (F1CDx) is a laboratory test designed to detect genetic mutations in 324 genes and two genomic signatures in tumor tissue. F1CDx is a companion diagnostic that was originally approved for the detection of genetic mutations 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 breast cancer patients with certain genetic mutations in the PIK3CA gene. Identifying these changes will help breast cancer patients get personalized treatment with PIQRAY® (alpelisib), a drug used to treat patients with breast cancer.

How does it work? The doctor orders the test. The doctor obtains a piece of tissue from the breast tumor of a patient, and the specially prepared sample is sent to Foundation Medicine, Inc. At Foundation Medicine, Inc., DNA is isolated from a breast tumor tissue section, and then mixed with chemical substances, called reagents, that detect and analyze the DNA sequences. The patient’s sequenced DNA is then evaluated for the presence or absence of PIK3CA mutations. A trained medical professional reviews the results, and then a report is sent to the ordering doctor. The doctor uses this information to help manage breast cancer patients. The presence of a mutation in the PIK3CA gene in a patient’s cancer tissue indicates that a patient with advanced or metastatic breast cancer is eligible for treatment with PIQRAY® (alpelisib).

When is it used? Doctors use F1CDx to help decide if a patient with advanced or metastatic breast cancer with a mutation in the PIK3CA gene is eligible for treatment with PIQRAY®.

What will it accomplish? The F1CDx test helps doctors identify if patients with advanced or metastatic breast cancer patients should be considered for treatment with PIQRAY® based on their test results.

When should it not be used? There are no known reasons not to use the test.

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