Foundationone® liquid cdx is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions, insertions and deletions (indels) in 311 genes, including rearrangements in three (3) genes, and copy number alterations in three (3) genes. Foundationone® liquid cdx utilizes circulating cell-free dna (cfdna) isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients collected in foundationone® liquid cdx cfdna blood collection tubes included in the foundationone® liquid cdx blood sample collection kit. The test is intended to be used 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. Table 1: companion diagnostic indicationstumor type biomarker(s) detected therapynon-small cell lung cancer (nsclc) egfr exon 19 deletions andegfr exon 21 l858r alteration iressa® (gefitinib)tagrisso® (osimertinib)tarceva® (erlotinib) alk rearrangements alecensa® (alectinib)prostate cancer brca1, brca2 alterations rubraca® (rucaparib)ovarian cancer brca1, brca2 alterations rubraca® (rucaparib)breast cancer pik3ca mutations c420r, e542k, e545a, e545d [1635g>t only], e545g, e545k, q546e, q546r, h1047l, h1047r, and h1047y piqray® (alpelisib)additionally, foundationone® liquid cdx 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. A negative result from a plasma specimen does not mean that the patient’s tumor is negative for genomic findings. Patients who are negative for the mutations listed in table 1 should be reflexed to routine biopsy and their tumor mutation status confirmed using an fda-approved tumor tissue test, if feasible. Genomic findings other than those listed in table 1 of the intended use statement are not prescriptive or conclusive for labeled use of any specific therapeutic product. Foundationone® liquid cdx is a single-site assay performed at foundation medicine, inc. In cambridge, ma.
| Device | FoundationOne Liquid CDx (F1 Liquid CDx) |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Foundation Medicine, Inc. |
| Date Received | 2020-02-03 |
| Decision Date | 2020-10-26 |
| PMA | P200006 |
| Supplement | S |
| Product Code | PQP |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Foundation Medicine, Inc. 150 Second Street cambridge, MA 02141 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200006 | Original Filing | |
| S003 | 2022-09-30 | Normal 180 Day Track No User Fee |
| S002 | 2022-08-22 | Special (immediate Track) |
| S001 | 2021-03-23 | Normal 180 Day Track No User Fee |