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  1. Recently-Approved Devices

FoundationOne CDx - P170019/S013

Image of FoundationOne CDx box

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, 1st Floor, Cambridge, MA 02141
Approval Date: April 17, 2020
Approval Letter: Approval Order

What is it? FoundationOne®CDx (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes, including FGFR2 gene variation, in tumor tissue. F1CDx is a companion diagnostic that was originally approved for the detection of genetic variations in patients who may be eligible for treatment with one of fifteen FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer.

This approval expands the indications for use of the F1CDx test to include bile duct cancer patients with genetic variationsin the FGFR2 gene. Identifying the genetic variations in FGFR2 will help patients with bile duct cancer get personalized treatment with PEMAZYRE® (pemigatinib).

How does it work? The doctor orders the test. A tissue sample from the bile duct tumor tissue of a patient is taken by the doctor, and the prepared sample is sent to Foundation Medicine, Inc. At Foundation Medicine, Inc., DNA is isolated from a tumor tissue section, and then mixed with chemical substances (reagents) that detect and analyze the DNA sequences. The patient’s sequenced DNA is then evaluated for the presence or absence of FGFR2 variations or other. A trained medical professional reviews the results, and then a report is sent to the ordering doctor. The doctor uses this information to help treat patients with bile duct cancer.

When is it used? Doctors use F1CDx to determine if a patient with bile duct cancer that is advanced (metastatic) or cannot be removed with surgery might be eligible for treatment with PEMAZYRE® (pemigatinib).

What will it accomplish? The F1CDx test helps doctors to decide if patients with bile duct cancer that is advanced (metastatic) or cannot be removed with surgery should be considered for treatment with PEMAZYRE® (pemigatinib).

When should it not be used? There are no known reasons not to use the test.

Additional information (including warnings, precautions, and adverse events):

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