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® Liquid CDx (F1 Liquid CDx)
Applicant:  Foundation Medicine, Inc.
Address:  150 Second Street, Cambridge, MA 02141
Approval Date:   November 6, 2020
Approval Letter:  Approval Order

What is it? 

The FoundationOne Liquid CDx is a laboratory test designed to detect the presence of mutations in the ATM, BRCA1 and/or BRCA2 genes in circulating cell-free DNA (cfDNA) that has been isolated from whole blood plasma specimens, also called liquid biopsy specimens, from patients with (metastatic) castration resistant prostate cancer (mCRPC).  This laboratory test is a companion diagnostic that can help doctors identify if patients with mCRPC may benefit from treatment with LYNPARZA® (olaparib).

How does it work?

A patient’s blood sample is sent to the laboratory for testing. At the laboratory, the blood is spun to separate the blood cells from the plasma portion. The cfDNA is then isolated from a patient’s plasma specimen.  The cfDNA is mixed with chemical substances, called reagents, that specifically detect and analyze mutations in ATM, BRCA1, or BRCA2 genes. A trained medical professional reviews the results and sends a report to the ordering doctor. The doctor uses this information to help create a treatment plan for patients with mCRPC.

When is it used?

FoundationOne Liquid CDx is used to test the blood samples from patients with mCRPC to determine if they are eligible for a specific therapy to treat their cancer.

What will it accomplish? 

Test results from the FoundationOne Liquid CDx are used to help doctors decide if patients with mCRPC can receive treatment with LYNPARZA® (olaparib). If mutations in ATM, BRCA1, or BRCA2 are not detected, then the patient’s eligibility for treatment of their cancer with the respective drugs should be determined by testing their tumor tissue specimen with an FDA approved tumor tissue test, unless a tumor biopsy cannot be obtained.

When should it not be used? 

There are no known reasons not to use this test.

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

• Summary of Safety and Effectiveness Data (SSED)
• Physician Labeling
• PMA Database entry