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  6. FoundationOne Liquid CDx (F1 Liquid CDx) – P190032/S011
  1. Recently-Approved Devices

FoundationOne Liquid CDx (F1 Liquid CDx) – P190032/S011


FoundationOne Liquid CDx - P200016


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 (F1LCDx)
Applicant: Foundation Medicine, Inc.
Address: 150 Second Street, Cambridge, MA 02141
Approval Date: October 11, 2023
Approval Letter: Approval Order

What is it?

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

This approval expands the indications for use of the FoundationOne Liquid CDx to include testing people with non-small cell lung cancer who may have a specific genetic mutation called BRAF V600E in their tumors. Identifying whether a person with non-small cell lung cancer has BRAF V600E may help determine if they will benefit from treatment with BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib).

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 after mixing with chemical substances, called reagents, that can find BRAF V600E. A medical professional review 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 non-small cell lung 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 MEKTOVI (binimetinib) for their non-small cell lung 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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