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
PMA Applicant: Foundation Medicine, Inc.
Address: 150 2nd Street 1st Floor, Cambridge, MA 02141
Approval Date: November 30, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf
What is it? FoundationOne CDx (F1CDx) is a laboratory test designed to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor. F1CDx is a companion diagnostic used to identify patients with certain genetic mutations who may benefit from FDA-approved treatments for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer.
When is it used? F1CDx is used to detect mutations in tumors from patients previously diagnosed with any type of solid tumor cancer, for clinical management purposes, including selection of appropriate FDA-approved treatments in certain cancer types.
The test is used to help doctors decide if a patient might be a candidate for following treatments:
- non-small cell lung cancer (NSCLC) patient with GILOTRIF® (afatinib), IRESSA® (gefitinib), TARCEVA® (erlotinib), TAGRISSO® (osimertinib), ALECENSA® (alectinib), XALCORI® (crizotinib), ZYKADIA® (ceritinib), or TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib).
- melanoma patient might be a candidate for treatment with TAFINLAR® (dabrafenib), ZELBORAF® (vemurafenib), MEKINIST® (trametinib), or COTELLIC® (cobimetinib) in combination with ZELBORAF® (vemurafenib).
- breast cancer patient might be a candidate for treatment with HERCEPTIN® (trastuzumab), KADCYLA® (ado-trastuzumab-emtansine), or PERJETA® (pertuzumab).
- colorectal cancer patient might be a candidate for treatment with ERBITUX® (cetuximab) or VECTIBIX® (panitumumab).
- ovarian cancer patient might be a candidate for treatment with RUBRACA® (rucaparib).
How does it work?
- The doctor orders the test. A tissue sample from the tumor of a patient is taken by the doctor, and the fixed sample is sent to Foundation Medicine, Inc.
- At Foundation Medicine, Inc., DNA is isolated from a tumor tissue section, and then mixed with reagents that specifically detect and analyze the DNA sequences. The patient's sequenced DNA is then evaluated for the presence or absence of mutations.
- A trained medical professional reviews the results, and then a report is sent to the ordering doctor.
- The report will indicate the mutations detected and which, if any, FDA-approved treatments may be appropriate for the patient.
What will it accomplish? F1CDx can help doctors identify patients who may benefit from treatment with targeted therapies for a variety of cancer types (listed above). This test provides profiling information on a number of different cancer tumor mutations that may help in the clinical management of oncology patients. This is an important advancement, because it allows patients and health care providers to access all of this information in one test report, and avoid duplicative biopsies.
When should it not be used? There are no known contraindications.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.
- FDA Press Release
- FDA Fact Sheet: CDRH's Approach to Tumor Profiling Next Generation Sequencing Tests