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FoundationOne CDx – P170019/S015


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: May 19, 2020
Approval Letter: Approval Order

What is it? FoundationOne® (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes and two genomic signatures in addition to homologous recombination repair (HRR) genes in tumor tissue. 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 prostate cancer patients with certain genetic mutations in the HRR genes. In prostate cancer, mutations in the HRR genes cause abnormal functioning of the HRR proteins resulting in defective homologous DNA repair. Identifying these genetic alterations will help prostate cancer patients to get personalized treatment with Lynparza (olaparib).

How does it work? The doctor orders the test and takes a small amount of cancer tissue from the patient’s prostate cancer tumor. The doctor sends the 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 detect and analyze mutations in the HRR genes. A trained medical professional reviews the results and sends a report to the ordering doctor. The doctor uses this information to help manage prostate cancer patients.

When is it used? Doctors use the results from F1CDx test to decide if patients with metastatic castration resistant prostate cancer (mCRPC) might be eligible for treatment with Lynparza (olaparib).

What will it accomplish? The F1CDx test helps doctors identify if select prostate cancer patients are eligible for treatment with Lynparza (olaparib) 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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