DeviceFoundationOne CDx
Classification Namenext generation sequencing oncology panel, somatic or germline variant detection system
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
Applicant
Foundation Medicine, Inc.
150 second street, 1st floor
cambridge, MA 02141
PMA NumberP170019
Date Received06/02/2017
Decision Date11/30/2017
Product Code
PQP[ Registered Establishments with PQP ]
Docket Number 17M-6799
Notice Date 12/15/2017
Advisory Committee Pathology
Expedited Review Granted? Yes
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling