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Guardant360 CDx - P200010/S010

Image of the external packaging for the Guardant360 CDx test.

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: 505 Penobscot Drive Redwood City, CA 94063 USA
Approval Date: January 27, 2023
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 people with breast 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 ESR1 missense mutations between codons 310 and 547 in patients with breast cancer. Identifying ESR1 missense mutations between codons 310 and 547 will help people with breast cancer get personalized treatment with ORSERDU (elacestrant).

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 a patient's plasma sample and mixed with chemical substances, called reagents, that find and test the DNA sequences for the ESR1 missense mutations between codons 310 and 547. 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 breast cancer.

When is it used?

Doctors use Guardant360 CDx to test if a patient with breast cancer may be eligible for a specific therapy or personalized treatment for their cancer.

What will it accomplish?

Guardant360 CDx helps doctors identify patients with breast cancer whose blood has DNA with ESR1 missense mutations between codons 310 and 547 and who may be eligible for treatment with ORSERDU (elacestrant) based on 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):

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