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: Guardant360 CDx
PMA Applicant: Guardant Health, Inc.
Address: Penobscot Drive
Redwood City, CA 94063 USA
Approval Date: August 11, 2022
Approval Letter: Approval order

What is it?

Guardant360 CDx is a laboratory test designed to detect gene mutations found 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 Guardant360 CDx to include the detection of ERBB2 activating mutations [single nucleotide variants (SNVs) and exon 20 insertions] in  patients with non-small cell lung cancer. Identifying these mutations will help doctors determine if a patient with non-small cell lung cancer may benefit from personalized treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki).  

How does it work?

A patient’s blood sample is sent to a laboratory for testing. At the laboratory, the blood cells are separated from the patient’s plasma. The cfDNA is isolated from the plasma sample and mixed with chemical substances, called reagents, that find and test the DNA sequences for the ERBB2 activating mutations (SNVs and exon 20 insertions). A trained 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?

Doctors use Guardant360 CDx to test if a patient with non-small cell lung cancer may be eligible for a specific therapy or personalized treatment for their cancer. 

What will it accomplish?

The Guardant360 CDx helps doctors identify patients with non-small cell lung cancer carrying ERBB2 activating mutations (SNVs and exon 20 insertions) who may be eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki) based on the test results. The test also provides information to the doctor about mutations in 55 genes that could be associated with the patient’s tumor.

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)
• Labeling
• PMA Database entry