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FoundationOne CDx – P170019/S014

FoundationOne CDx

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 CDx (F1CDx)
PMA Applicant: Foundation Medicine, Inc.
Address: 150 Second Street, Cambridge, MA 02141
Approval Date: May 31, 2022
Approval Letter: Approval order

What is it?

FoundationOne CDx is a laboratory test designed to find genetic variations in 324 genes, as well as some specific gene rearrangements and other biomarkers, including microsatellite instability (MSI) in the genomic makeup of a tumor.

This test is a companion diagnostic that is used to help match a patient to a specific drug or therapy. It is approved to find genetic mutations in patients that might show they would benefit from FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, bile duct cancer (cholangiocarcinoma), prostate cancer, ovarian cancer, and solid tumors.

This approval expands the indications for use of the FoundationOne CDx test to include patients with non-small cell lung cancer who have a gene fusion in their ROS1 gene. The approval also includes an indication for patients with solid tumors who have gene fusions in three genes: NTRK1, NTRK2, or NTRK3. Identifying non-small cell lung cancer with ROS1 gene fusions and solid tumors with rearrangements in NTRK1, NTRK2, NTRK3 may help doctors determine if a patient will benefit from treatment with ROZLYTREK (entrectinib).

How does it work?

The doctor orders the FoundationOne CDx test and takes a small amount of cancer tissue from the patient. The tissue sample is sent to the laboratory for testing. At the laboratory, DNA is separated from the tumor cells and mixed with chemical substances, called reagents, that find and test the DNA sequences. The tumor’s sequenced DNA is then reviewed by a trained medical professional to see if these gene fusions are present. The report is sent to the patient’s doctor, and the doctor uses this information to help manage the care of the patient’s cancer.

When is it used?

Doctors use FoundationOne CDx to test if a patient with solid tumors or non-small cell lung cancer may be eligible for a specific therapy to treat their cancer.

What will it accomplish?

The Foundation CDx helps doctors identify patients with solid tumors or non-small cell lung cancer who may be eligible to receive treatment with ROZLYTREK (entrectinib) 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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