| 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. |
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| Device | FoundationOne CDx |
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| Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
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| Applicant | Foundation Medicine, Inc.
400 Summer St.
Boston, MA 02210 |
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| PMA Number | P170019 |
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| Date Received | 06/02/2017 |
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| Decision Date | 11/30/2017 |
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| Product Code |
PQP |
| Docket Number | 17M-6799 |
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| Notice Date | 12/15/2017 |
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| Advisory Committee |
Pathology |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S011 S012 S013 S016 S017 S002 S003 S018 S019 S036 S037
S038 S032 S042 S043 S034 S048 S061 S062 S063 S058 S059 S060
S007 S008 S009 S010 S021 S022 S023 S020 S005 S006 S014 S015
S004 S044 S045 S049 S050 S035 S028 S029 S025 S026 S030 S033
S039 S040 S041 S053 S065 S067 S051 S052 S054 S056 S057 S046
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