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  1. Recently-Approved Devices

FoundationOne Liquid CDx (F1 Liquid CDx) – P190032/S005


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:   May 3, 2023
Approval Letter: Approval Order

What is it?

The FoundationOne Liquid CDx assay is a laboratory test designed to detect several mutations in circulating cell-free DNA (cfDNA). This test helps doctors identify people with cancer 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 non-small cell lung cancer who have an EGFR exon 20 insertion in their tumor DNA. Identifying whether a patient has this insertion may help people with non-small cell lung cancer get personalized treatment with EXKIVITY (mobocertinib).

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 patient’s plasma. The cfDNA is isolated from the plasma and mixed with chemical substances, called reagents, that find insertions in EGFR exon 20. A medical professional reviews the results and sends a report to the patient’s 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 patient 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 doctors identify patients with non-small cell lung cancer who may be eligible to receive treatment with EXKIVITY (mobocertinib) 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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