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FoundationOne Liquid CDx – P190032/S001

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: July 15, 2021
Approval Letter: Approval Order

What is it?

The FoundationOne Liquid CDx assay is a laboratory test designed to find a number of different mutations in circulating cell-free DNA (cfDNA). This test helps doctors identify patients with non-small cell lung cancer who may benefit from specific FDA-approved treatments.

This approval expands the indications for use of the FoundationOne Liquid CDx test to include patients who have non-small cell lung cancer (NSCLC), a type of lung cancer, with certain genetic mutations in the MET gene of their tumors. Identifying these changes will help patients with lung cancer get personalized treatment with TABRECTA® (capmatinib).

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 plasma. The cfDNA is then separated from the plasma and mixed with chemical substances, called reagents, that find and test mutations in the MET gene. A medical professional reviews the results and sends a report to the patient’s doctor. The doctor uses this information to help manage the care of patients with non-small cell lung cancer.

When is it used?

FoundationOne Liquid CDx is used to test the blood of patients with non-small cell lung cancer 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 non-small cell lung cancer can receive treatment with TABRECTA (capmatinib). If mutations in MET 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):

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