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.
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)
| Device | FoundationOne CDx |
| Classification Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Foundation Medicine, Inc. |
| Date Received | 2017-06-02 |
| Decision Date | 2017-11-30 |
| Notice Date | 2017-12-15 |
| PMA | P170019 |
| Supplement | S |
| Product Code | PQP |
| Docket Number | 17M-6799 |
| Advisory Committee | Pathology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Foundation Medicine, Inc. 150 Second Street, 1st Floor cambridge, MA 02141 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170019 | Original Filing | |
| S038 | 2022-08-29 | Special (immediate Track) |
| S037 | ||
| S036 | ||
| S035 | 2022-06-09 | Normal 180 Day Track No User Fee |
| S034 | 2022-03-18 | Normal 180 Day Track No User Fee |
| S033 | 2021-12-23 | Real-time Process |
| S032 | ||
| S031 | ||
| S030 | 2021-07-01 | Normal 180 Day Track |
| S029 | ||
| S028 | 2021-03-23 | Normal 180 Day Track |
| S027 | ||
| S026 | 2020-12-28 | Normal 180 Day Track |
| S025 | ||
| S024 | ||
| S023 | 2020-12-01 | Normal 180 Day Track |
| S022 | ||
| S021 | 2020-10-29 | Normal 180 Day Track |
| S020 | 2020-07-20 | Real-time Process |
| S019 | 2020-04-27 | Real-time Process |
| S018 | 2020-04-16 | 30-day Notice |
| S017 | ||
| S016 | ||
| S015 | 2019-12-16 | Panel Track |
| S014 | ||
| S013 | 2019-10-31 | Panel Track |
| S012 | 2019-10-21 | Special (immediate Track) |
| S011 | ||
| S010 | ||
| S009 | 2019-07-23 | Special (immediate Track) |
| S008 | 2019-04-09 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | 2018-10-12 | Normal 180 Day Track |
| S004 | 2018-09-24 | Normal 180 Day Track |
| S003 | 2018-08-30 | Real-time Process |
| S002 | 2018-08-24 | Real-time Process |
| S001 |