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  1. Recently-Approved Devices

FoundationOne Liquid CDx (F1 Liquid CDx) – P190032/S010

FoundationOne Liquid CDx – P190032


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:  June 8, 2023
Approval Letter: Approval Order

What is it?

The FoundationOne Liquid CDx assay is a laboratory test that detects a number of mutations in circulating cell-free DNA (cfDNA). This test helps doctors identify people who may benefit from specific FDA-approved treatments.

This approval expands the indications for use of the FoundationOne Liquid CDx test to include people with metastatic colorectal cancer who have a change to the DNA of their tumors (BRAF V600E alteration). Identifying whether a patient has a BRAF V600E alteration in their tumor may help determine if they may benefit from personalized treatment with BRAFTOVI (encorafenib) in combination with cetuximab.

How does it work?

A patient’s blood sample is sent to the laboratory for testing. At the laboratory, the blood cells are separated from the plasma. The cfDNA is then isolated from the plasma and mixed with chemical substances, called reagents, that find alterations in BRAF V600E. 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 Liquid CDx to test if a person with metastatic colorectal cancer is eligible for a specific therapy or personalized treatment for their cancer.

What will it accomplish?

FoundationOne Liquid CDx helps identify people who may be eligible to receive treatment with BRAFTOVI (encorafenib) in combination with cetuximab for their metastatic colorectal cancer.

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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