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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceFoundationOne CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second Street, 1st Floor
Cambridge, MA 02141
PMA NumberP170019
Date Received06/02/2017
Decision Date11/30/2017
Product Code PQP 
Docket Number 17M-6799
Notice Date 12/15/2017
Advisory Committee Pathology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the FoundationOne CDx (F1CDx). This device is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. Additionally, F1CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. The F1CDx assay is a single-site assay performed at Foundation Medicine, Inc.Table 1: Companion diagnostic indicationsIndication: Non-small cell lung cancer (NSCLC). - Biomarker: EGFR exon 19 deletions and EGFR exon 21 L858R alterations. Therapy: Gilotrif® (afatinib), Iressa® (gefitinib), or Tarceva® (erlotinib). - Biomarker: EGFR exon 20 T790M alterations. Therapy: Tagrisso® (osimertinib). - Biomarker: ALK rearrangements. Therapy: Alecensa® (alectinib), Xalkori® (crizotinib), or Zykadia® (ceritinib). - Biomarker: BRAF V600E. Therapy: Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib).Indication: Melanoma. - Biomarker: BRAF V600E. Therapy: Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib) - Biomarker: BRAF V600E and V600K. Therapy: Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib).Indication: Breast cancer. Biomarker: ERBB2 (HER2) amplification. Therapy: Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), orPerjeta® (pertuzumab).Indication: Colorectal cancer. - Biomarker: KRAS wild-type (absence of mutations in codons 12 and 13). Therapy: Erbitux® (cetuximab) - Biomarker: KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4). Therapy: Vectibix® (panitumumab)Indication: Ovarian cancer. Biomarker: BRCA1/2 alterations. Therapy: Rubraca® (rucaparib)
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S025 
S026 S028 S029 S030 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S048 S049 S050 S051 S053