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FoundationOne Liquid CDx – P190032

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
PMA Applicant:  Foundation Medicine, Inc.
Address:  150 Second Street, Cambridge, MA 02141
Approval Date:   August 26, 2020
Approval Letter:  Approval Order

What is it?  The FoundationOne Liquid CDx is a lab test that detects specific gene mutations found in circulating cell-free DNA (cfDNA) isolated from whole blood plasma specimens, also called liquid biopsy specimens to help doctors identify patients with metastatic castration resistant prostate cancer who may benefit from treatment with the cancer drug RUBRACA. (rucaparib).  It can also help identify patients with non-small cell lung cancer  who may benefit from treatment with IRESSA (gefitinib), TAGRISSO (osimertinib), or TARCEVA (erlotinib). This lab test is a companion diagnostic for these indications.

For patients with mCRPC, the assay detects the presence of mutations in the “BReast Cancer”genes, BRCA1 and BRCA2 will help prostate cancer patients get personalized treatment with RUBRACA® (rucaparib).

For patients with NSCLC, the assay detects the presence of specific mutations in the epidermal growth factor receptor (EGFR) gene (i.e., exon 19 deletions and exon 21 L858R substitution mutations) will help lung cancer patients get personalized treatment with IRESSA® (gefitinib), TAGRISSO® (osimertinib), or TARCEVA® (erlotinib).

How does it work?  A patient’s blood sample is sent to a lab for testing. The cfDNA is separated from the sample and mixed with chemical substances, called reagents, that find and test the DNA for changes in the genes. A medical professional reviews the results and sends a report to the patient’s doctor. The doctor uses this information to help create a treatment plan for patients with metastatic castration resistant prostate cancer and non-small cell lung cancer.

When is it used?  The FoundationOne Liquid CDx test is used to test the blood of patients with metastatic castration resistant prostate cancer or non-small cell lung cancer. However, if the specific mutations in the BRCA1, BRCA2, or EGFR genes are not found, then the patient’s eligibility for treatment of their cancer with the specific drugs should be determined by testing their tumor tissue specimen with an FDA approved tumor tissue test, unless a tumor biopsy cannot be done.

What will it accomplish?  Test results from the the FoundationOne Liquid CDx test are used to help doctors match patients with prostate cancer or non-small cell lung cancer with an appropriate drug to treat their disease.

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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